Pubblicazione schede-paese-borderline1

La registrazione dei dispositivi medici a base
di sostanze in alcuni Paesi extraeuropei
Una disamina dei diversi contesti, requisiti e richieste,
sulla base di esperienze sul campo
Prima Edizione

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A cura di Enrico Porri
Si ringraziano le Imprese associate che hanno contribuito fattivamente alla
realizzazione della presente pubblicazione.

1
INTRODUZIONE
Scopo di questa analisi è dare un quadro di sintesi delle procedure e requisiti per
la registrazione di dispositivi medici a base di sostanze (di classe I-III secondo la
Direttiva Europea 93/42 e successive modifiche e integrazioni) in diversi Paesi
extra-UE.
Per l’esportazione nei Paesi extra-UE di dispositivi medici è spesso necessaria una
vera e propria registrazione con requisiti specifici a seconda dei casi e variabili per
tempistiche (dalla semplice valutazione documentale, fino ad arrivare ad una vera
e propria analisi qualitativa-quantitativa del prodotto da registrare a studi di
stabilità o di biocompatibilità).
Eterogenei anche i requisiti sul piano documentale: un certificato di libera vendita
dal Paese di origine, piuttosto che la certificazione ISO 13485 del produttore e/o
fabbricante, nonché in taluni casi una certificazione GMP del produttore o la
registrazione dell’azienda. Senza contare dichiarazioni di vario genere relative a
prodotto, processo, produttori, prezzi, etc. piuttosto che il confezionamento
riportante scritte in lingua locale.
Anche sul fronte degli studi clinici, non sempre vengono accettati quelli
riconosciuti in Europa, richiedendone quindi di specifici.
Gli elementi riportati sono da intendersi frutto dell’esperienza acquisita in tali
Paesi con diversi prodotti negli ultimi anni da parte di Imprese associate che
hanno reso disponibile la propria esperienza sul campo. Questo al fine di dare un
contributo di approccio ai diversi Paesi per quelle Imprese che intendono iniziare
ad operare all’estero, in un contesto – quello dei dispositivi medici a base di
sostanze – nel quale può risultare in taluni addirittura differente la classificazione
dei prodotti come dispositivi medici piuttosto che essere riclassificati come
cosmetici o farmaci o come dispositivi medici di una classe differente.
Disclaimer: Tutti i contenuti delle schede raccolte nel documento sono di proprietà
esclusiva e riservata delle singole aziende, e/o dei loro aventi causa, e/o terzi
soggetti e protetti dalle vigenti norme nazionali e internazionali in materia di
tutela dei diritti di proprietà intellettuale e/o industriale.
Assobiomedica dichiara che i contenuti del presente documento sono frutto
dell'attività di studio e ricerca delle singole aziende e che i dati contenuti, in
considerazione del continuo evolversi della materia, potrebbero non essere
aggiornati, in tutto o in alcune delle sue parti.
Assobiomedica declina pertanto ogni responsabilità per eventuali inesattezze
contenute nel documento e ogni responsabilità rispetto a qualunque tipo di utilizzo
fatto da terzi del materiale in esso contenuto.

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SOMMARIO
INTRODUZIONE.........................................................................................................1
SOMMARIO...............................................................................................................3
PAESI EUROPEI .........................................................................................................5
BOSNIA......................................................................................................................7
KOSOVO ....................................................................................................................9
MACEDONIA............................................................................................................10
MONTENEGRO........................................................................................................11
SERBIA.....................................................................................................................12
SVIZZERA .................................................................................................................14
TURCHIA..................................................................................................................15
PAESI AMERICANI...................................................................................................17
ARGENTINA.............................................................................................................19
BRASILE ...................................................................................................................20
CANADA ..................................................................................................................25
COSTA RICA.............................................................................................................29
EL SALVADOR ..........................................................................................................31
GUATEMALA ...........................................................................................................33
HONDURAS .............................................................................................................35
MESSICO..................................................................................................................36
PANAMA .................................................................................................................38
REPUBBLICA DOMINICANA.....................................................................................40
VENEZUELA .............................................................................................................42
PAESI CIS.................................................................................................................49
AZERBAIJAN.............................................................................................................51
BIELORUSSIA ...........................................................................................................52
GEORGIA .................................................................................................................54
KAZAKISTAN............................................................................................................55
RUSSIA.....................................................................................................................59

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TURKMENISTAN......................................................................................................61
UCRAINA .................................................................................................................63
PAESI AFRICANI ......................................................................................................65
ALGERIA...................................................................................................................67
EGITTO ....................................................................................................................68
LIBIA ........................................................................................................................70
MAROCCO...............................................................................................................71
SUD AFRICA.............................................................................................................72
PAESI MEDIO ORIENTE...........................................................................................73
ARABIA SAUDITA.....................................................................................................75
EMIRATI ARABI UNITI..............................................................................................77
GIORDANIA .............................................................................................................79
IRAN ........................................................................................................................81
IRAQ ........................................................................................................................89
ISRAELE....................................................................................................................91
KUWAIT...................................................................................................................92
LIBANO....................................................................................................................93
QATAR.....................................................................................................................94
SIRIA........................................................................................................................96
PAESI ASIATICI........................................................................................................97
CINA ........................................................................................................................99
COREA DEL SUD.....................................................................................................101
FILIPPINE ...............................................................................................................103
HONG KONG..........................................................................................................105
INDONESIA............................................................................................................114
MALESIA................................................................................................................117
SINGAPORE ...........................................................................................................118
TAILANDIA.............................................................................................................124
TAIWAN.................................................................................................................126
VIETNAM...............................................................................................................137

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BOSNIA
(Rev. 0 – 2012)
Prodotti: Dispositivi medici di classe I-III classificati in
Europa secondo la Direttiva 93/42 e
successive modifiche e integrazioni
Procedure di autorizzazione: registrazione
Tempo necessario per la
registrazione:
12 mesi
Tasse ministeriali: fino a 200 euro (dipende dalla classe di
rischio del dispositivo)
Documentazione necessaria: vedi tab.1
Analisi di prodotto: no
Materiale di confezionamento: lingua locale
Criticità E’ necessario nominare un distributore
locale e presentare una lettera di
autorizzazione per il distributore.
Sono richiesti il certificato ISO13485 ed il
certificato di libera vendita.
Necessari studi clinici e/o expert report
clinico.
Richiesta copia della assicurazione contro
danni causati dai dispositivi
Validità della registrazione: 5 anni
Requisiti per l’importazione: n.a.

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Tab. 1 – Documentazione per la registrazione dei dispositivi medici in Bosnia e
Herzegovina

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KOSOVO
(Rev. 0 – 2012)
Procedure di autorizzazione: nessuna registrazione/notifica è necessaria
registrazione:
n.a.
Tasse ministeriali: n.a.
Documentazione necessaria: n.a.
Analisi di prodotto: n.a.
Materiale di confezionamento: preferibilmente labelling in lingua locale
Criticità Nessuna
Validità della registrazione: n.a.
Requisiti per l’importazione: per dispositivi medici non sterili:
- certificato CE o Dichiarazione di
conformità
- ISO9001 o ISO13485
Per dispositivi medici sterili:
- certificato CE o Dichiarazione di
conformità
- ISO9001 o ISO13485
- certificato di sterilità per ciascun lotto
In caso il Fabbricante sia diverso dal
Produttore o dall’Azienda che rilascia il
lotto, l’Autorità locale richiede uno
statement al Fabbricante.

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MACEDONIA
(Rev. 0 – 2012)
Tab. 1 – Documentazione per la registrazione dei dispositive medici in Macedonia
ISO 9001 Certificate
CE certificate
Free Sale Certificate
Declaration of Conformity
FDA approval (if available)
Certificate of Analysis
Liability Insurance
Label
Instruction for use
Prodotti: Dispositivi medici di classe I – III classificati
in Europa secondo la Direttiva 93/42 e
successive modifiche e integrazioni.
Procedure di autorizzazione: Registrazione
registrazione:
210 giorni
Tasse ministeriali: 1.000 euro di tasse amministrative, a cui si
aggiungono 500 euro per ogni singolo
dosaggio.
Analisi di prodotto: SI
Materiale di confezionamento: Il box può essere in inglese, tuttavia è
obbligatorio apporvi uno sticker in lingua
macedone.
Il foglio illustrativo in lingua macedone è
obbligatorio.
Criticità Tutti i documenti devono essere in
originale oppure legalizzati.
E’ richiesto il certificato di libera vendita.

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MONTENEGRO
(Rev. 0 – 2012)
Tab. 1 – Documentazione per la registrazione dei dispositive medici in Montenegro
EC-Certificate
ISO 13485 certificate
Free sale Certificate
Policy Insurance
Letter of authorization
Manufacturer’s statement that will, upon request of the Agency, provide the technical file
for Medical Devices.
registrazione:
12 mesi
Tasse ministeriali: Sino a 350 € (dipende dalla classe di rischio
del dispositivo)
Analisi di prodotto: NO
Materiale di confezionamento: Lingua locale
Criticità Alcuni documenti devono essere legalizzati
dal consolato, con relativi costi e tempi.
Viene richiesto il Certificato 13485
Validità della registrazione: Per i classe I, IIa e IIb dipende dalla data
della dichiarazione di conformità, mentre
per i classe III dipende dalla data del
Certificato CE.

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SERBIA
(Rev. 0 – 2012)
registrazione:
3 mesi
Tasse ministeriali: SI
Materiale di confezionamento: E’ ammesso l’utilizzo di materiale di
confezionamento in lingua inglese (anche
multilingua), con foglietto in serbo allegato
esternamente per importazioni annuali
molto ridotte.
Per la nomale commercializzazione
astuccio e foglietto in Serbo sono
obbligatori.
Criticità Molti documenti devono essere in originale
o copia conforme.
Necessità di nominare un distributore
locale.
E’ richiesta una dichiarazione di copertura
assicurativa del prodotto nel territorio.
Validità della registrazione: L’autorizzazione ha una scadenza
(solitamente 90 giorni dalla scadenza della
certificazione EU) e deve essere rinnovata
periodicamente

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Tab. 1 – Checklist documentation required to obtain licence for importing and
distributing medical devices with CE mark in Serbia
All documentations must be from COUNTRY OF ORIGIN, where is PRODUCT registered,
manufactured and sold
All mentioned documents should be original or notarized and also within expiry date
(at least 1 year)
1 EC-certificate NOTARIZED
2 ISO (QMS) -certificate (13485) NOTARIZED or
ORIGINAL
3 Declaration of conformity ORIGINAL (or
NOTARIZED COPY)
4 Free sale certificate NOTARIZED or
ORIGINAL
NOT OLDER THAN 6
MONTHS
5 Product liability insurance policy
worldwide or local (Serbian)
NOTARIZED or
ORIGINAL
(Products Liability insurance provides
coverage to manufacturers and
distributors for bodily injury and
property damage resulting from
products sold.)
6 Product name
7 Generic name for all the variants
8 Package insert /Instructions for
Use/Service Manual, both English
and Serbian language version
MULTILINGVAL
VERSION IS
ALLOWED
(TO BE SIGNED
AND SEALED BY
local CLINICAL
DOCTOR)
9 Labeling, both English and Serbian
language version
MULTILINGVAL
VERSION IS
ALLOWED
(Serbian printed package is obligatory
only for products directly assigned.
For the products directly delivered to
the doctor only sticker in Serbian is
obligatory)
10 Information on Shelf life and
stability data- storage conditions
11 GMDN code
12 Distribution agreement, both
English and Serbian language
version
(NOTARIZED)
13 Manufacturer statement that the
local partner is authorized to
obtain marketing authorization at
Serbian authorities orig.

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SVIZZERA
(Rev. 0 – 2012)
Procedure di autorizzazione: La Svizzera riconosce la normativa europea
in materia di dispositivi medici. Nessuna
registrazione/notifica è necessaria.
registrazione:
n.a.
Documentazione necessaria: Il Distributore locale deve tenere a
disposizione la documentazione attestante
la marcatura CE (per dispositivi superiori
alla Classe I).
Analisi di prodotto: n.a.
Materiale di confezionamento: Italiano, francese, tedesco.
Criticità Nessuna

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TURCHIA
(Rev. 0 – 2012)
Tab. 1 – Documentazione per la registrazione dei dispositive medici in Turchia
CE Certificate
13485 Certificate
To obtain the reimbursement: declaration of fully Reimbursement by the Health Care
System in other european countries (if applicable)
Declaration on sale prices in other european countries
registrazione:
6 - 12 mesi
Tasse ministeriali: NO
Materiale di confezionamento: Turco
Criticità Molti documenti devono essere legalizzati,
con relativi costi e tempi.
Sono richiesti il certificato ISO 13485 ed il
Validità della registrazione: Senza limite fino alla scadenza del
Certificato CE (pertanto, alla scadenza di
questo documento è necessario effettuare
nuovamente la registrazione).

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ARGENTINA
(Rev. 0 – 2012)
Tab. 1 – Lista dei documenti per la registrazione dei dispositivi medici in Argentina
Campioni di prodotto finito e relativi certificati di analisi
Metodi analitici e relative convalide per il prodotto finito
Working standard e relativi certificati d’analisi
FSC a postillato
Certificato GMP a postillato
Certificati CE a postillati
Prodotti: Dispositivo medico di classe I-III classificato
registrazione:
12/24 mesi
Tasse ministeriali: Fino a 400 € (a seconda della classe di
rischio cui appartiene il dispositivo)
Metodi analitici e relative convalide per il
prodotto finito.
Analisi di prodotto: SI (campioni prodotto finito unitamente ai
working standard)
Materiale di confezionamento: Lingua locale
Criticità Certificato GMP.
Il GMP, i Certificati CE e il FSC devono
essere a postillati.
Non è richiesto il certificato ISO 13485.

20
BRASILE
(Rev. 0 – 2012)
Procedure di autorizzazione: Registrazione del prodotto.
Al termine della procedura viene assegnato
un numero di registrazione, che viene
pubblicato nella Gazzetta Ufficiale
brasiliana.
registrazione:
n.d.
Documentazione necessaria: vedi tab.1, 2, 3 e 4
Materiale di confezionamento: Portoghese
Criticità La classificazione locale non rispecchia
completamente la classificazione EU.
E’ necessario nominare un
distributore/rappresentante locale.
Viene richiesto il Certificato di Libera
Vendita ed il Certificato ISO 13485.
Richiesti dati tecnici oltre a clinici, preclinici
e di biocompatibilità.

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Tab. 1 – Lista dei documenti per il Brasile
The manufacturers or importers at the moment of request the registration of medical
products fell under in classes II, III and IV shall submit to ANVISA the following documents:
a) Voucher of payment of the corresponding surveillance sanitary duties.
b) Information for identifying the manufacturer or importer and its medical product
described in Annexes III.A, III.B and III.C of the present document, declared and signed
by legal responsible and technical responsible.
c) Copy of the authorization from manufacturer or exporter in the exterior addressed
to the importer to market its medical product in the Country. When authorized by the
exporter, the importer shall demonstrate the trade relationship between exporter
and manufacturer.
d) For imported medical products, receipt of registration or certificate of free-market
or equivalent document, granted by the competent authority of countries where the
medical product is manufactured and/or marketed.
e) Certificate of compliance with legal provisions established in the technical
regulations, in the form of ANVISA law which regulates medical products.
The manufacturers or importers requesting the registration of medical products fell under
in class I, shall submit to ANVISA the documents indicated in sections 5(a), 5(b) and 5(e).
Tab. 2 – Annex III.A - FORM OF MEDICAL PRODUCTS MANUFACTURER OR IMPORTER
1 – Identification of the Process
1.1 Register of the Product
1.2 Cadastre of the Product
1.3 Alteration
1.4 Revalidation
1.5 Cancellation
No. Register of the Product in M.S. [Health Ministry] in cases 1.3, 1.4 or 1.5)
2 – Data of the Manufacturer or Importer
2.1 – Corporate Name
2.2 – Fantasy Name
2.3 – Address
2.4 – City
2.5 – State
2.6 – Post Code
2.7 – LDC, Phone
2.9 – LDC, Fax
2.11 – E-mail
2.12 – Authorization for Operation in ANVISA No.
3 – Data of the Product
3.1 – Technical Identification of the Product
Technical Name

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Identification Code
In accordance with Codification and Nomenclature of Medical Products
NCM Code in accordance with Common Nomenclature of Merchandise
3.2 - Commercial Identification of the Product(s)
Trade Name of the Product(s)
Commercial Model of the Product
For family of products, fill out this field for each product model
3.3 – Classification of Risk of the Product
Classification Rule Class
Where the Product is fell under
3.4 – Origin of the Product:
Brazil/Abroad
Manufacturer
Manufacturing Country of the Product
Distributor
Origin Country of the Product
4 – Statement of the Legal Responsible and Technical Responsible
“I hereby declare that the information rendered in this Form are true and can be
proven by documentation available in the Enterprise
<Name, charge and signature of Legal Responsible >
<Name, charge and signature of the Technical Responsible>”
Tab. 3 – Annex III.B - INFORMATION ABOUT LABELS AND INSTRUCTIONS FOR USE OF
MEDICAL PRODUCTS
1 - General Requirements
1.1 The information contained in the label and in the instructions for use shall be
written in Portuguese language
1.2 All the medical products shall include instructions for use in their packaging.
Exceptionally, these instructions can not be included in the packaging of products
fell under in Classes I and II, provided that the safety of use of these products can
be guaranteed without such instructions.
1.3 The necessary information for the correct and safe use of medical products shall
be available, whenever possible and appropriate, in the own product and/or in
the label of its individual packaging or, if this is impossible, in the label of its
commercial packaging. If it is not possible to individually package each unit, the
information shall be contained in the instructions for use, which accompany one
or more medical products.
1.4 When appropriate, the information can be presented under the form of symbol
and/or color. The symbols and colors used for identification shall be in
accordance with technical regulations or rules. If there are not regulations or
norms, the symbols and colors shall be described in the documentation that
accompanies the medical product.
1.5 If there is the need of supplementary information for a technical regulation of a
specific medical product due to the product specificity, this information shall be
incorporate to the label or instructions for use, as applicable.

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2 - Labels
The model label shall contain the following information:
2.1 Corporate name and manufacturer and importer address, according to the case.
2.2 The strictly necessary information for the user identify the medical product and
the content of its packaging;
2.3 When applicable, the word: "Sterile";
2.4 The batch code, preceded of the word: "Batch", or the serial number, according
to the case;
2.5 As applicable, production date and validity period or the shelf life of the medical
product is appropriate for use in full safety;
2.6 When applicable, the indication that the medical product is for single use;
2.7 The special conditions of storage, conservation and/or manipulation of the
medical product;
2.8 The instructions for use of the medical product;
2.9 All the warnings and/or precautions to be adopted;
2.10 When applicable, the sterilization method;
2.11 Name of the technical responsible legally qualified for the function;
2.12 Number of the medical product registration, preceded of the identification
acronym of ANVISA.
3. Instructions for Use
The model of the instructions for use shall contain the following information, as
applicable:
3.1 The information indicated in section 2 of this Annex (label), except the information
contained in Paragraphs 2.4 and 2.5;
3.2 The performance foreseen in the General Requirements of the ANVISA regulation
disposing about the Essential Requirements for Safety and Effectiveness of
Medical Products, as well as any eventual undesirable secondary effects;
3.3 In the event of a medical product must be installed or connected to other
products to operate in agreement with the foreseen purpose, information
sufficiently detailed must be supplied about its characteristics to identify the
products that can be used with this product, for it is obtained a safe combination;
3.4 All information that make possible to prove a medical product are well installed
and it can work correctly and in complete safety, as well as the relative
information to the nature and frequency of the maintenance operations and
calibration to be accomplished to guarantee the good permanent operation and
the safety of the product;
3.5 Useful information to avoid certain risks from the implantation of medical
product;
3.6 Relative information to the risks of reciprocal interference from the presence of
medical product in trials or specific treatments;
3.7 The necessary instructions in case of damage of the packaging which protect the
sterility of a sterilized medical product, and when applicable the indication of
appropriate restirilization methods;
3.8 For reusable medical product, if the product has to be restirilized, information
about the appropriate procedures for reuse, including cleaning, disinfection,
packaging and, according to the case, sterilization method, as well as any
restrictions for the possible number of reuse. If the medical product must be
sterilized before its use, the relative instructions for the cleaning and sterilization

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shall be formulated so that, if they be executed correctly, the product satisfies
the requirements foreseen in the General Requirements of the ANVISA regulation
which disposes about Essential Requirements for Safety and Effectiveness of
Medical Products;
3.9 Information about treatment or additional procedure that should be performed
before using the medical product (for instance, sterilization or final assembly,
among other).
3.10 In the event of a medical product to emit radiations for medical purposes, the
information relative to the nature, type, intensity and distribution of referred
radiations, shall be described. The instructions for use shall include information
that allow to the medical personnel to inform the patient about contraindications
and precautions to be took. Those information shall contain, specifically:
3.11 The precautions to be adopted in case of alteration of the medical product
operation;
3.12 The precautions to be adopted regarding the exposition, in environmental
conditions reasonably previsible, to magnetic fields, external electric influences,
electrostatic discharges, pressure or variations of pressure, acceleration and
thermal sources of ignition, among others;
3.13 Appropriate information about the medicine(s) which the medical product is
destined to administer, including any restrictions on the selection of those
substances;
3.14 Precautions to be adopted if the medical product represent a specific and
unexpected risk associated with its elimination;
3.15 The medicines incorporated to the medical product as an integral part of this,
according to section 7.3 of the ANVISA regulation which disposes about the
Essential Requirements for Safety and Effectiveness of Health Products;
3.16 The level of accuracy attributed to medical products of measurement.
Tab. 4 – Annex III.C – TECHNICAL REPORT
The technical report shall contain the following information:
1.1. Detailed description of the medical product, including the foundations of its operation
and its performance, and its content or composition, when applicable, as well as the
list of accessories intended for integrating the product;
1.2. Indication, purpose intended for the medical product use, in accordance with the
manufacturer information;
1.3. Precautions, restrictions, warnings, special cares and explanations about the medical
product use, as well as its storage and transport;
1.4. Presentation forms how the medical product is supplied;
1.5. Flowchart containing the stages of production process of the medical product with a
summarized description of each process stage, until obtaining the finished product;
1.6. Description of effectiveness and safety of the medical product, in accordance with
ANVISA regulation which disposes about the Essential Requirements for Safety and
Effectiveness of Medical Products. In the case of this description not to prove the
product effectiveness and safety, the ANVISA shall request a clinical research for the
product.
In case of registration of a medical product fell under in Class I, the Technical Report shall
contain the information foreseen in section 1.1 to 1.4 of the present Annex.

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CANADA
(Rev. 0 – 2012)
Procedure di autorizzazione: Registrazione del prodotto (per classe II –
IV)
registrazione:
75 – 175 giorni, vedi tab.1
(da 270 a 15.000 Euro, a seconda della
classe e del prodotto)
Ci sono poi le Annual fees
Materiale di confezionamento: Inglese e Francese
Criticità La classificazione locale non rispecchia
E’ necessario nominare un
distributore/rappresentante locale.
Viene richiesto il Certificato ISO13485 con
requisiti per il Canada.
Richiesti dati tecnici oltre a clinici, preclinici
e di biocompatibilità.
Validità della registrazione: Va rinnovata ogni anno
(entro il 1° novembre)

26
Tab. 1 – TIMELINES (IN CALENDAR DAYS)
Target timeline for Class III medical device applications is:
15 days screening + 60 days review = 75 days
If a screening deficiency letter is received, the target timeline is:
15 days screening and issuance of screening deficiency letter + 15 calendar days for
manufacturer to respond + new 15 day screening period + 60 day review period = 90 days
If more information is required and an Additional Information letter is issued during
review, the review will stop and the manufacturer will have 60 calendar days to respond.
This will be followed by a new 10 calendar day screening period followed by a 30 day
review period = total of 175 days
Tab. 2 – APPLICATION FOR A MEDICAL DEVICE - DUCUMENTATION REQUIRED
An application for a medical device licence shall be submitted to the Minister by the
manufacturer of the medical device in a format established by the Minister and shall
contain the following:
(a) the name of the device;
(b) the class of the device;
(c) the identifier of the device, including the identifier of any medical device that is part
of a system, test kit, medical device group, medical device family or medical device
group family;
(d) the name and address of the manufacturer as it appears on the device label; and
(e) the name and address of the establishment where the device is being manufactured,
if different from the one referred to in paragraph (d).
An application for a Class II medical device licence shall contain, in addition to the
information and documents set out in subsection (1), the following:
(a) a description of the medical conditions, purposes and uses for which the device is
manufactured, sold or represented;
(b) a list of the standards complied with in the manufacture of the device to satisfy the
safety and effectiveness requirements;
(c) an attestation by a senior official of the manufacturer that the manufacturer has
objective evidence to establish that the device meets the safety and effectiveness
requirements;
(d) an attestation by a senior official of the manufacturer that the device label meets the
applicable labeling requirements of these Regulations;
(e) in the case of a near patient in vitro diagnostic device, an attestation by a senior
official of the manufacturer that investigational testing has been conducted on the
device using human subjects representative of the intended users and under
conditions similar to the conditions of use; and
(f) a copy of the quality management system certificate certifying that the quality
management system under which the device is manufactured satisfies National

27
Standard of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality management
systems — Requirements for regulatory purposes.
An application for a Class III medical device licence shall contain, in addition to the
1. a description of the device and of the materials used in its manufacture and
packaging;
2. a description of the features of the device that permit it to be used for the medical
conditions, purposes and uses for which it is manufactured, sold or represented;
3. a list of the countries other than Canada where the device has been sold, the total
number of units sold in those countries, and a summary of any reported problems
with the device and any recalls of the device in those countries;
4. a list of the standards complied with in the design and manufacture of the device to
satisfy the safety and effectiveness requirements;
5. in the case of a device to be sold in a sterile condition, a description of the
sterilization method used;
6. a summary of all studies on which the manufacturer relies to ensure that the device
meets the safety and effectiveness requirements, and the conclusions drawn from
those studies by the manufacturer;
7. a copy of the device label;
8. in the case of a near patient in vitro diagnostic device, a summary of investigational
testing conducted on the device using human subjects representative of the intended
users and under conditions similar to the conditions of use;
9. a bibliography of all published reports dealing with the use, safety and effectiveness
of the device; and
10. a copy of the quality management system certificate certifying that the quality
management system under which the device is designed and manufactured satisfies
National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality
management systems — Requirements for regulatory purposes.
An application for a Class IV medical device licence shall contain, in addition to the
(a) a description of the device and of the materials used in its manufacture and
packaging;
(b) a description of the features of the device that permit it to be used for the medical
conditions, purposes and uses for which it is manufactured, sold or represented;
(c) a list of the countries other than Canada where the device has been sold, the total
number of units sold in those countries, and a summary of any reported problems
with the device and any recalls of the device in those countries;
(d) a risk assessment comprising an analysis and evaluation of the risks, and the risk
reduction measures adopted to satisfy the safety and effectiveness requirements;
(e) a quality plan setting out the specific quality practices, resources and sequence of
activities relevant to the device;
(f) the specifications of the materials used in the manufacture and packaging of the
device;
(g) the manufacturing process of the device;

28
(h) a list of the standards complied with in the design and manufacture of the device to
satisfy the safety and effectiveness requirements;
(i) detailed information on all studies on which the manufacturer relies to ensure that
the device meets the safety and effectiveness requirements, including
1. pre-clinical and clinical studies,
2. process validation studies,
3. if appropriate, software validation studies, and
4. literature studies;
(j) in the case of a medical device other than an in vitro diagnostic device, manufactured
from or incorporating animal or human tissue or their derivative, objective evidence
of the biological safety of the device;
(k) in the case of a near patient in vitro diagnostic device, detailed information on
investigational testing conducted on the device using human subjects representative
of the intended users and under conditions similar to the conditions of use;
(l) a summary of the studies referred to in paragraph and the conclusions drawn from
those studies by the manufacturer;
(m) a summary of the investigational testing referred to in paragraph (k) and the
conclusions drawn from that testing by the manufacturer;
(n) a bibliography of all published reports dealing with the use, safety and effectiveness
of the device;
(o) a copy of the device label; and
(p) a copy of the quality management system certificate certifying that the quality
management system under which the device is designed and manufactured satisfies
National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality
management systems — Requirements for regulatory purposes.

29
COSTA RICA
(Rev. 0 – 2012)
Procedure di autorizzazione: Registrazione del prodotto
registrazione:
6-10 mesi
Valutazione documentale.
Materiale di confezionamento: Spagnolo (anche multilingua).
Criticità Alcuni documenti devono essere legalizzati,
con relativi tempi.
E’ richiesto il certificato di libera vendita e
il certificato ISO 13485.
La classificazione locale non rispecchia
E’ richiesta documentazione a supporto di
sicurezza ed efficacia (e.g. clinical expert
report).
Sono previste variazioni in caso di
modifiche dei termini della registrazione.

30
Tab. 1 – Documenti necessari (Classe 1, 2, 3, 4)
Per tutte le categorie di dispositivi:
- certificato GMP
- certificato di libera vendita e certificato di registrazione nel paese d’origine (o certificato
CE, ove applicabile).
Per i Classe 2, oltre i punti 1 e 2:
- Specifiche tecniche ed intended use
- Lista dei paesi dove il dispositivo è commercializzato
- Procedura di vigilanza del fabricante (o riassunto)
- Studi clinici
- Dichiarazione sul metodo di sterilizzazione, se applicabile
- Lista dei paesi dove il dispositivo è commercializzato
- Procedura di vigilanza del fabricante (o riassunto)
- Studi clinici
- Dichiarazione sul metodo di sterilizzazione, se applicabile
- Analisi dei rischi
- Bibliografía clinica a supporto
- In caso di dispositivi fabbricati a partire da tessuti umani o animali, o loro derivati,
documentazione attestante la sicurezza
- Layout
- Attestazione di pagamento tasse ministeriali

31
EL SALVADOR
(Rev. 0 – 2012)
registrazione:
2 mesi
Tasse ministeriali: SI (60 USD)
Materiale di confezionamento: Spagnolo
E’ necessario nominare un rappresentante
locale.
I documenti devono essere in Spagnolo.
Richiesto il certificato di libera vendita.
Devono essere pagate delle tasse annuali.

32
Tab. 1 – Documenti necessari
- Power of attorney, legalized by a Notary Public
- Signed and sealed application by the owner, its legal representative or attorney
legally authorized according each case and by the chemical-pharmacy representative
professional.
- Payment receipt for the registration procedure.
- Current Certificate of Free Sale legally authenticated by the pertinent authorities, if
the device is imported from another country. If in the certificate is declared more
than one device it should be provided as a copy legalized by a Notary Public;
- Original Good Manufacturing Practices Certificate or other current sanitary similar
rules and legalized. If in the certificate is declared more than one device it should be
provided as a copy legalized by a Notary Public;
- Technical information of the product
- National language packaging is required and the packing project should be presented
when doing the application.

33
GUATEMALA
(Rev. 0 – 2012)
registrazione:
1-2 mesi
Documentazione necessaria: vedi tab.1 e 2
Materiale di confezionamento: Spagnolo (accettabile multilingue e
stickers)
Molti documenti devono essere in
Spagnolo.
E’ necessario nominare un distributore ed
un rappresentante locale.
Sono richiesti: il certificato di libera vendita
ed i certificati ISO 13485.
E’ accettato il materiale di
confezionamento europeo, anche
multilingua.

34
- Certificate of Free Sale duly consularized and legalized of the country of origin
- Warranty Certificate of Manufacture issued by a Health Authority (any of the
following): GMP, Approval Norms, Certificate ISO 9001, FDA, DGKC or IFCC) duly
consularized and legalized
- Power of Attorney of the Authorization Holder duly consularized and legalized
- Specifications of the Finished Product in Spanish (Extended by the manufacturing
laboratory) duly signed, sealed and in letterhead
- Analytical Method in Spanish (if applicable)
- Certificate of Analysis in original issued by the manufacturer
- Description of the product in Spanish
- Product technical literature, catalog or insert (in Spanish), if applicable
- Primary packaging and Secondary packaging (4 examples in original) or artworks
Tab. 2 – Requirements of packaging
SECONDARY PACKAGING
Name of the Product (Registered Mark)
Instructions for use or form of use and warning
Quantity or content
Number of Batch
Number of the Health Registration
Name of the Manufacturer and manufacturing site
Expiry Date (if applicable)
Legend: Sterile (if applicable)
Measures (if applicable)
PRIMARY PACKAGING
Name of the Product (Registered Mark)
Number of Batch
Expiry Date (if applicable)
Legend: Sterile (if applicable)
Measures (if applicable)

35
HONDURAS
(Rev. 0 – 2012)
Certificado de Venta Libre
Declaración Jurada en la que el fabricante y Titular del registro garantiza la calidad y
asume la responsabilidad por la seguridad del producto a registrar.
Monografia del producto
Especificaciones si fuera el caso
Artworks
registrazione:
5-6 mesi
Tasse ministeriali: SI (circa 120 Euro)
Materiale di confezionamento: Spagnolo (accettabile multilingue)
E’ richiesto il certificato di libera vendita
Può essere richiesto il certificato ISO
13485.

36
MESSICO
(Rev. 0 – 2012)
registrazione:
12/24 mesi
Tasse ministeriali: Dai 500 ai 1000 € a seconda della classe di
rischio del dispositivo.
Materiale di confezionamento: In lingua spagnola.
Criticità Diversi documenti devono essere
legalizzati, con relativi tempi e costi.
Sono richiesti: il certificato ISO 13485, il
certificato di libera vendita, il certificato
GMP.
Sono accettati gli studi di stabilità in
condizioni ICH per zona II (Europa); non
sono richiesti studi aggiuntivi o modifica
packaging.

37
Tab. 1 – Requirements for sanitary register for Medical Devices in Messico
N.B.: Alla 2.3.9.6, si intende ”Vigilance report”

38
PANAMA
(Rev. 0 – 2012)
registrazione:
3-6 mesi, a seconda del prodotto (più lunga
se il prodotto contiene “sostanze attive”)
Analisi di prodotto: SI (se il prodotto contiene “sostanze
attive”)
Materiale di confezionamento: Spagnolo (accettabile multilingue, ma non
gli stickers)
E’ necessario nominare un distributore ed
un rappresentante locale.
Sono richiesti: il certificato di libera vendita
ed i certificati ISO 13485.
Puo’ essere richiesta documentazione a
supporto di sicurezza ed efficacia (e.g.
report di Biocompatibilità e clinical expert
report)
E’ accettato il materiale di
confezionamento europeo, anche
multilingua.
Sono richiesti campioni.
Validità della registrazione: Illimitata

39
Tab. 1 – Documenti necessari per la registrazione a Panama
Letter of authorisation
Free Sale Certificate (FSC)
EC Certificates
Biocompatibility Report may be required
Clinical Expert Report may be required
Packaging
One sample

40
REPUBBLICA DOMINICANA
(Rev. 0 – 2012)
Tab. 1 – Documentos legales
Poder de Representación de la Empresa titular a favor del Establecimiento
Farmacéutico (Apostillado)
Certificado de Libre Venta Original, Apostillado emitido por la Autoridad Sanitaria
Certificado de Buenas Practicas Original, Vigente y Apostillado
Copia de Marca de Onpi
registrazione:
8 mesi
Tasse ministeriali: SI (80 Euro)
E’ necessario nominare un rappresentante
locale.
I documenti devono essere in Spagnolo.
Richiesto il certificato di libera vendita.
Devono essere pagate delle tasse annuali.

41
Tab. 2 – Documentos técnicos
1. Descripción del Producto: Listado de las Partes Principales de que esta hecho el
producto y su composición Cuali- Cuantitativa, Especificaciones, funcionamiento e
información descriptiva.
2. Planos o Esquema del Producto en las que se puedan verificar las características del
producto (Dispositivo Medico).
3. En caso de Solicitud de Familias de Productos (Dispositivos Médicos)
- Anexar Resumen con la Descripción de la familia de Productos.
- Listado de códigos o productos que componen la familia
4. Estudios Técnicos y Comprobaciones analíticas. Resumen de Pruebas de Diseño y
Especificaciones del Producto.
5. Métodos de Fabricación con esquema, Descripción de procesos y Controles.
6. Métodos de Control de calidad para procesos de fabricación del producto firmado
por control de calidad.
7. Certificados de Análisis Original del Producto Terminado que Incluya Pruebas
Quimicos-Fisicas, Microbiológicas, Pirógenos esterilidad. que incluya el numero de
lote, Fecha de fabricación y Expiración del producto, asi como los valores o rangos de
aceptación , que corresponda alas muestras depositadas, firmado por control de
calidad.
8. Dos Muestras Originales del producto terminado con validez al menos de un año.
9. Método de Desechos o Disposición final del producto
10. Información de uso Profesional que incluya usos e indicaciones, advertencias,
precauciones, contraindicaciones y nivel de riesgo del producto.

42
VENEZUELA
(Rev. 0 – 2012)
Tab. 1 – Lista documentazione
ISO 13485
CE Certificates
GMP certificate
Letter showing the countries where the product is sold
Power of Attorney
Prodotti: Dispositivi medici di classe I – III classificati in
Europa secondo la Direttiva 93/42 e successive
modifiche e integrazioni
registrazione:
12-24 mesi
Documentazione necessaria: vedi tab. 1 e 2
Criticità Molti documenti devono essere legalizzati dal
consolato, con relativi costi e tempi.
certificato di libera vendita, oltre che il
certificato GMP.
Validità della registrazione: n.d.

43
Tab. 2 – Contenuto del dossier

51
AZERBAIJAN
(Rev. 0 – 2012)
registrazione:
1-2 mesi
Valutazione documentale e analisi del
prodotto, insieme ad eventuale valutazione
clinica e tossicologica.
Tasse ministeriali: SI (circa 700-900 Euro)
Documentazione necessaria: Lettera
Application form
Certificato d’analisi
Packaging, incluso foglietto
Campioni
Materiale di confezionamento: Confezionamento in Inglese e Azeri o
Russo, con foglietto in Azeri
Criticità n.a.
Validità della registrazione: 6 mesi

52
BIELORUSSIA
(Rev. 0 – 2012)
Tab. 1 – Documentazione richiesta
1. Application form (vedi tab.21)
2. Documents certifying the quality of the products, issued in the country of the
manufacturer (legalised with apostille); e.g.
- certificates of conformity,
- quality management system certificates,
- certificates of free sale,
- declaration of conformity by the manufacturer,
registrazione:
6-12 mesi
Materiale di confezionamento: Russo (anche multilingua). Stickers
accettabili.
con relativi tempi.
E’ necessario nominare un contatto locale.

53
- registration certificate.
3. Layout of the product, the instruction on the use of medical products certified by
the manufacturer.
4. Protocols of testing.
Tab. 2 – Application form
APPLICATION
for state registration (renewal of registration)
of a medical device, medical equipment
1. Applicant's name (country, de jure address) ……………………………..………………………………
2. Manufacturer's name (manufacturing country, de jure address) ……………………………….
3. The name of a medical device and (or) medical equipment, the title of the regulatory
and technical documentation in accordance with which the medical device, medical
equipment is manufactured (if any) ……………………………………………………………………………
4. List of parts (configuration) of the medical device and (or) medical equipment
(specifying the part names) ………………………………………………………………………………………..
5. Whether any changes in the registration dossier have occurred since the date of
registration of the medical device and (or) medical equipment (specify the kind of
changes) ……………..……………………………………………………………………………………………………
6. Availability of CE mark (description of package, marking) ……..…………………………..………
7. Main indications for application, mode of application of the medical device and (or)
medical equipment ………………………………………………………………………………………………..….
8. Shelf (operation) life of the medical device and (or) medical equipment ……..……….……
9. Storage conditions of the medical device and (or) medical equipment .……………………..
10. The price of the medical device and (or) medical equipment in the manufacturing
country .....………………………………………………………………………………………………………..…………
The applicant shall assume the responsibility for effectiveness, safety and quality of the
medical device and (or) medical equipment, as well as guarantee reliability of the
information in the registration dossier and the present application.

54
GEORGIA
(Rev. 0 – 2012)
Composition of the products
Reccomendation of Usage
Status in the country of origin
Certificate of origin
Procedure di autorizzazione: Registrazione non obbligatoria
registrazione:
n.a.
Materiale di confezionamento: Inglese o Russo (preferibile)
Criticità Nessuna

55
KAZAKISTAN
(Rev. 0 – 2012)
registrazione:
9 mesi
prodotto, insieme ad eventuale
valutazione clinica e tossicologica.
Tasse ministeriali: SI (circa 100 € + analisi)
Materiale di confezionamento: Russo/Kazako (anche multilingua).
con relativi tempi.

56
Tab. 1 – List of documents required for registration, re-registration of product for
medical use according to Safety Class
No. Name of document
Product for medical use
RemarkClass
1
Class 2a
Class
2b
Class
3
MIBA
medical
immunobiological
agents -
(in-vitro)
1. Application + + + + +
As per approved
form
2.
The power of attorney for the
right to represent interests of
manufacturer during state
registration in the Republic of
Kazakhstan
+ + + + +
According to
International
certification rules
3.
Data on manufacturer
including name, kind of
activity, legal address, pattern
of ownership, management
structure, list of divisions and
affiliated companies with their
legal status and powers
+ + + + +
Is provided by
parent enterprise
of manufacturer
4.
The document certifying
registration of product for
medical use in manufacturing
country, and/or Free Sale
Certificate
+ + + + +
According to
International
certification rules
5.
The document of conformity
of production conditions to
national and/or international
standards (GMP; ISO; EN)
+ + + + +
According to
International
certification rules
6.
Registration Certificate of the
Republic of Kazakhstan for
Pharmaceutical product
included in product for
medical use
+ + + +
Notary certified
copy
7.
The document of conformity
of product for medical use to
standard requirements of
National or International
Normative Documents
(Conformity Declaration;
Conformity Certificate)
+ + + + +
According to
International
certification rules
8.
The report of toxicological and
hygienic tests for the product
for medical use, including raw
materials used in products for
medical use and being the
product for medical use
+ + + +
Certified by
stamp of
manufacturer
9. The report on technical
examination of product for
+ + + + Certified by
stamp of

57
medical use, including raw
material used in product for
medical use and being a
manufacturer
10.
Stability test report (if shelf-
life is specified) for products
for medical use, including raw
material used in product for
medical use and being a
+ + + + +
Certified by
stamp of
manufacturer
11.
The report on pre-clinic (noт-
clinical) studies
+ (in presence of
pharmaceutical
agent)
+ +
Certified by
stamp of
manufacturer
12.
Results of clinic (medical)
studies (application of product
for medical use)
+ (in presence of
pharmaceutical
agent)
+ + +
Certified by
stamp of
manufacturer
13.
Normative document, which
requirements shall be met for
products for medical use:
international and/or national
standard, Internal standard
and/or specifications
+ + + + +
Copy of Internal
Standard /
Specification shall
be certified by
stamp of
manufacturer.
National /
International
Standard should
have relevant
record in Register
of RK
14.*
Specification with technical
characteristics, list of
accessories/components (as
per approved form)
+ + + + +
Shall be provided
in electronic and
hard copy. Hard
copy is certified
by stamp of
manufacturer
15.
Instruction for Use of product
for medical use (Original
document from manufacturer)
+ + + + +
Certified by
stamp of
manufacturer
16.
Draft of Instruction for Use in
Russian and Official language
(hard-copy and electronic
version)
+ + + + +
Certified by
authorized
person
17.
Samples of product for
medical use
+ + + + +
In quantity
sufficient for
threefold analysis
according to the
requirements of
Normative
Document
18.
Standard samples (if their use
is mentioned in Normative
Document) of: material used
for production of product for
medical use; pharmaceutical
agent contained in product for
medical use; control materials
for diagnostic test systems and
+ + + + +

58
reagents; impurities; including
raw material and components
for product for medical use,
which is a product for medical
use
19.
The documents regulating
quality of package materials
(for primary package)
+ + + + +
National /
International
Standard should
have relevant
record in Register
of RK
20.
Coloured photos (not less than
13х18 cm) (representing
appearance of the product,
components and accessories)
+ + + + +
21.
Coloured models of package
and label (hard copy and
electronic version)
+ + + + +
Certified by
stamp of
manufacturer
22.
Wording of label in Russian
and Official language (hard
copy and electronic version)
+ + + + +
Certified by
authorized
person
23.
Copy of Registration
Certificate of RK for Re-
registration
+ + + + +
24.
Copy of document confirming
State Registration in other
countries
+ + + + +
Certified by
stamp of
manufacturer
Note: Documents should be provided with translation into Russian. For the documents
required certification, notarization of translation into Russian is obligatory.
The applicant is responsible for reliability and accuracy of such document.
*Form of Specification for the product for medical use:
Name Manufacturing
country
(manufacturer)
Package contents Field of
application,
indication
Technical data
Name of
components
Manufacturer,
country
4.
5.
6.

59
RUSSIA
(Rev. 0 – 2012)
Procedure di autorizzazione: Registrazione del prodotto a nome di una
azienda russa.
registrazione:
9-24 mesi
prodotto, insieme a eventuale valutazione
Tasse ministeriali: SI (tasse amministrative e per le analisi, che
possono raggiungere i 10-12.000 euro, esclusi
costi per eventuali studi clinici e di
biocompatibilità)
Materiale di confezionamento: Russo (anche multilingua). Stickers accettabili.
Criticità Possono essere richiesti studi clinici e di
biocompatibilità locali.
Alcuni documenti devono essere legalizzati, con
relativi tempi e costi.
E’ richiesto il certificato di libera vendita e il
certificato ISO 13485.
Validità della registrazione: Illimitata.
Il “Certificate of compliance” e la“Declaration
of compliance” locali vengono rinnovati ogni 3
anni.

60
Tab. 1 – Lista documentazione richiesta
1. Application for registration
2. Information about Medical Device, containing:
- Name of the product
- Description of product (including assortment, modifications, versions of device,
dimensions)
- Description of operating principle of product.
- Information about functional characteristics related to operating principles (including
design, using materials and physical properties).
- Information about field of application, including short description of diseases and
conditions, in which this medical device can be used for diagnostics, treatment,
prophylaxis or improvement condition. If available, definition frequency of occurrence of
such diseases or conditions. (including opportunity of use in different terms: inpatient use,
transportable use, portable use, use in medical transport, in field conditions and others).
- Photo of product or illustrated materials.
3. Draft of Normative Document (quality analytical documentation)
- the function of the product
- special characteristics, which only this medical device has
- technical specifications (description, using materials, list of chemical substances, physical
and mechanical characteristics, microbiological characteristics, methods of control,
description of package and marking, storage conditions and shelf life).
- description of condition of transportation
- description of packaging
- storage and shelf life
4. Instruction for use
5. Documents confirming registration of the manufacturer in his country.
6. Documents confirming compliance with the conditions of manufacture of the medical
device to requirements of the legislation of the Russian Federation (ISO 13485)
7. Documents confirming the conformity of medical devices to technical requirements
or standards, e.g.:
- Declaration of Conformity (medical device products classes 1 and 2a);
- Certificate of Conformity (medical device products classes 2b, 3);
8. Power of Attorney from the manufacturer to the firm of the applicant
9. Certificate of Tax Registration of the applicant (notarized copy)
10. Certificate of registration of legal entity of the applicant (notarized copy)
11. An extract from the register (notarized copy)
12. Document certifying the payment of state fees
13. Composition
14. Mock-ups
N.B.: Foreign documents must be Apostilled.
Tab. 2 – Lista documentazione aggiuntiva che può venire richiesta
Valutazione clinica
Procedure del Sistema di Qualità
Certificato GMP
Studi di biocompatibilità
Specifiche dei componenti
Studi di stabilità

61
TURKMENISTAN
(Rev. 0 – 2012)
registrazione:
5/6 mesi
Tasse ministeriali: SI (circa 1400 USD)
Materiale di confezionamento: Inglese/Russo (anche multilingua). Stickers non
accettabili.
Criticità Alcuni documenti devono essere legalizzati, con
relativi tempi.
certificato ISO 13485.

62
Tab. 1 – List of the documents on registration of medical products (equipment) in
Turkmenistan
1. Manufacturer’s letter
2. Power of attorney issued by the manufacturer to the authorized legal entity/ in the
name of its head/ for the purpose of registration.
3. Application for the registration of products for medical use and medical equipment,
detailing:
- Trade name
- Note patented name
- Composition
- Indications
- Standart packaging
- Manufacturer
4. Certificate of medical product containing brief confirmation about its use main
specification /in Russian/
5. Photo /size not less 130x180 mm/ of the medical product / equipment.
6. Official document confirming the trade name of the medical product and medical
equipment /patent if available/. If the product for medical use and medical
equipment are an assemblage all its constituents should be specified.
7. Advertising and illustrative materials.
8. Copy of the state registration certificate issued to the manufacturer.
9. Documents about registration certificate of the medical product in the manufacturer’s
country and/or other countries/if available/.
10. Foreign document /national or international/ confirming compliance of the medical
product to requirements of national or international normative documents and
specifying its manufacturing process.
11. Manufacturer’s instructions on service /usage/ of medical products /in Russian/
All documents are to be submitted in duplicate /original and copy in 2 separate files.

63
UCRAINA
(Rev. 0 – 2012)
Tab. 1 – Lista documentazione per registrazione prodotto
- Name/Address of the finished medical device product manufacturer
- Power of Attorney
- Legal Status of Commercial registration of the manufacturing facilities
- Declaration on relationship between Applicant and Manufacturer, if they are not the
same company
registrazione:
6-18 mesi.
Ottenuta la registrazione del prodotto, è
necessario ottenere anche una certificazione di
conformità (lotto specifica o valida da 1 a 5
anni), vedi tab.2
Tasse ministeriali: 12.000 euro circa.
Documentazione necessaria: vedi tab. 1
Materiale di confezionamento: Ucraino e preferibile anche russo
Criticità Molti documenti devono essere legalizzati, con
relativi costi e tempi.
E’ necessario presentare la procura a favore del
Rappresentante locale.
Sono richiesti: i certificati ISO 13485 e il
Puo’ essere richiesto il certificato ISO 9001.
Sono richiesti campioni per le analisi.

64
- Certificate of origin
- EC certificates
- Certificates as applicable: FDA (for USA origin), ISO 9001, 13485.
- Free Sale certificate & registration certificate in other countries
- Declaration of Conformity by manufacturer
- Declaration on Clarification of Catalogue Numbers of device as laid down in Annex IX
of Medical Device Directive 93/42EEC of 14 June 1993. On the company’s letterhead.
- Certificate of analysis/conformity/quality On the company’s letterhead, stamped and
signed by QA Manager.
- Patient leaflet/Instruction for use.
- Product(s) specification/Specification sheet
- Pre-clinical and clinical data
- Technical data/dossier (if available)
- The results of microbiological tests and toxicology information (if applicable)
- Sterility and validation data (for sterile forms)
- Samples
- Mock-ups/ images of product secondary & primary package (preferably as in printed
view and in jpg format)
- Brochures, catalogues.
All mentioned data is mandatory. Other legal, scientific, technical data with regard to
applied product could be required in process of evaluation in accordance with expert
opinion.
Samples & materials intended for registration in Ukraine to be imported with special
permission from Health Authorities
Tab. 2 – Certificazione prodotto
Certification of a medical device is carried out after the state registration, and is a
separate procedure. The certification purpose is acknowledgement of conformity of
production to Ukrainian quality standards.
The conformity certificate is given out for a batch, for a year, to 3 years and to 5 years. The
company-applicant for certification has the right to choose the certification scheme
independently.
The conformity certificate for a batch of goods is given out for a concrete delivery of
production to Ukraine (the Invoice on delivery), on the basis of product samples test. It is
the fastest way of certification.
The conformity certificate on a batch production is given out for a period of 1 calendar
year, on the basis of examination of the documentation and tests of samples. Most likely,
this variant of certification is the most widespread.
The conformity certificate on a batch production with inspection of a manufacturing site is
given out for a period up to 2 years, on the basis of examination of the documentation
and inspection of a manufacturing site. In case of carrying out of certification of
manufacture, the conformity certificate can be given out for a period of 3 years.
The conformity certificate on quality system of the whole manufacturing site is given out
for a period up to 5 years, on the basis of the complete expert examination of quality
system and manufacture inspection.

67
ALGERIA
(Rev. 0 – 2012)
CE Certificate
Ex-factory price
Pharmaceutical Manufacturing Authorization
GMP Certificate
List of countries where the product is marketed
registrazione:
12-24 mesi
Analisi di prodotto: n.d.
Materiale di confezionamento: Francese e arabo preferibilmente

68
EGITTO
(Rev. 0 – 2012)
registrazione:
12/24 mesi
Dopo una prima valutazione documentale, si
prosegue con l’analisi del prodotto e
l’autorizzazione del prezzo.
Tasse ministeriali: 1500 euro circa
Per le analisi: Campioni di prodotto finito e
standards, con relativi metodi/convalide
Materiale di confezionamento: Inglese accettabile (anche multilingua)
E’ necessario nominare un distributore locale e
presentare il contratto di distribuzione.
E’ richiesto il certificato ISO 13485 ed il
Sono accettati gli studi di stabilità in condizioni
ICH per zona II (Europa); non sono richiesti
studi aggiuntivi o modifica packaging.
E’ possibile l’ottenimento di permessi di
importazione ministeriali per un quantitativo
limitato di prodotto.
Requisiti per l’importazione: Per la prima importazione possono richiedere
metodi d’analisi con convalida + convalida
processo.
Ad ogni importazione richiesti: Specifiche
componenti + Certificato standard componente
principale (e relativo campione) + Metodi
analitici prodotto finito + Convalide metodi
analitici prodotto finito.

69
1. Application form
2. Hard copy of
- Importer Record
- S14 in case of agency
- Commercial Record
3. Updated legalized hardcopy of
- Distributing contract, agency of the relation between foreign factory and distributor
- Free sale (2007-2008)
- CE certificate
- ISO certificate No.13485
- Shelf life certificate of product
n.b. Legalization must be from Egyptian Embassy and Commercial Chamber
4. Hardcopy stamped from the Factory for:
- Risk analysis certificate
- Sterility certificate
- Material composition
- No. of product certificate (legalized from Commercial Chamber)
5. Certificate of:
- Declaration of conformity of the product including
o Quality
o Class & use
- Packaging material specification
- No mad cow disease if ingredient is from animal origin
6. Shelf life study of product
7. Photocopy of external label & leaflet
8. Sample released & stamped from custom house
Tab. 2 – Documentazione aggiuntiva
- Biocompatibility Report o estratto con timbro ed in originale
- Metodi analitici con relative validazioni con timbro ed in originale
- Dichiarazione di conformita’ agli standard ISO applicabile al materiale di
confezionamento/scheda tecnica
- Proforma invoice per il permesso di importazione per l’invio dei campioni
- Letter of appointment al distributore
- Manufacturing process flow diagram
- Dichiarazione di prezzo

70
LIBIA
(Rev. 0 – 2012)
Procedure di autorizzazione: Classificazione del prodotto come medical
device da parte del Quality Control Center.
registrazione:
1 - 2 mesi
Documentazione necessaria: EC Certificates
2 confezioni
locale/agente.
L’autorizzazione è rilasciata indicando il nome
scientifico o generico (non il marchio)

71
MAROCCO
(Rev. 0 – 2012)
Free sale certificate
Declaration on ex-factory price
ISO 13485
GMP Certificate
CE Certificate
Clinical evaluation
Biocompatibility studies
Campioni
modifiche e integrazioni.
registrazione:
24 mesi
Materiale di confezionamento: In francese (anche multilingue)
Criticità Alcuni documenti devono essere legalizzati dal
consolato, con relativi costi e tempi. Vengono
richiesti i Certificati ISO 13485 e il GMP.
Vengono richiesti un paio di centinaia di
campioni per analisi.

72
SUD AFRICA
(Rev. 0 – 2012)
Procedure di autorizzazione: Registrazione del prodotto SOLO SE contiene
un principio farmacologicamente attivo,
altrimenti non è richiesta alcuna
registrazione/notifica.
registrazione:
Se necessaria la registrazione, i tempi sono di
circa 24/36 mesi
Tasse ministeriali: SI (dipendono dal tipo di prodotto)
Documentazione necessaria: Se il prodotto contiene un principio
farmacologicamente attivo è necessario
sottomettere un dossier completo farmaco in
CTD.
Analisi di prodotto: Dipende dal prodotto
Materiale di confezionamento: Inglese.
Se il prodotto contiene un principio
farmacologicamente attivo: Inglese e Afrikaans.
Criticità E’ necessario nominare un distributore locale.
Necessario presentare una confezione di
prodotto finito.
Se il prodotto contiene un principio
farmacologicamente attivo è necessaria la
registrazione del prodotto con documentazione
analoga a quella per il farmaco.

75
ARABIA SAUDITA
(Rev. 0 – 2012)
Procedure di autorizzazione: Registrazione del prodotto.
La prima fase (MDNR) viene considerata una
prima approvazione dei dispositivi medici.
Mentre la MDMA è la registrazione finale.
Tuttavia la commercializzazione dei dispositivi è
consentita anche ai dispositivi che abbiano un
numero MDNR.
registrazione:
6 mesi circa.
Tasse ministeriali: 3000 – 5000 euro circa, a seconda della classe
del dispositivo
locale/authorized representative e presentare il
contratto di distribuzione legalizzato.
E’ richiesto il certificato ISO 13485.
Validità della registrazione: MDMA valida fino alla scadenza del certificato
CE di riferimento o altrimenti valida per 3 anni.
Requisiti per l’importazione: Possono richiedere certificati CE e dichiarazione
di conformità

76
Original letter of authorization of the local representative/distributor, duly legalized by the
Consulate of Saudi Arabia
Agreement between manufacturer and local authorised representative
Original Declaration on the relationship between involved companies, if more than one
Copy of the EC Certificates
Copy of the Declaration of Conformity
Copy of EN ISO 13485
Copy of the Free Sale Certificate
English leaflet
Tab. 2 – Altra documentazione
Dichiarazione relativa al mantenimento delle condizioni di conservazione e distribuzione
nella catena distributiva (sulla base delle relative SOP del distributore locale)
SOP del fabbricante relative alla vigilanza ed al sistema di qualità
Dichiarazione che il dispositivo rispetta le disposizioni delle Medical Device regulations
Dichiarazione che il dispositivo rispetta le disposizioni del Global Harmonization Taskforce
Dichiarazione relativa alla vigilanza, dove ci si impegna a riportare alla Saudi FDA ogni
evento avverso di cui il fabbricante viene a conoscenza e che il fabbricante applica le
disposizioni locali (MDS - IR7)
Copia del materiale promozionale che si intende utilizzare nel paese o dichiarazione per la
sua presentazione futura o giustificazione per l’assenza
Copia dell’ultimo report ispettivo dell’ente notificatore

77
EMIRATI ARABI UNITI
(Rev. 0 – 2012)
Procedure di autorizzazione: Registrazione del prodotto e del produttore
(inclusi eventuali terzisti)
registrazione:
12/18 mesi
Tasse ministeriali: 1200 € circa per la registrazione del
produttore.
Materiale di confezionamento: Inglese e Arabo
Criticità La registrazione del produttore/i è contestuale
a quella del prodotto.
Alcuni documenti devono essere legalizzati dal
E’ richiesto il certificato di libera vendita.

78
- Application form per prodotto
- Application form per il/i produttore/i
- Free Sale Certificate
- Declaration of conformity
- CE Certificate
- Standard Operating Procedures for: Distribution records, Complaint handling,
Adverse incident reporting and recall
- Status of the device distribution (list of countries in which the device is marketed)
with details of regulatory status (e.g. marketing approval, product recall, product ban,
ect.) in each country, together with a summary of the “mandatory” reported
problems with the device since the introduction of the device in these countries
- Device information (Intended use, instruction for use, contraindications, warnings,
precautions, potential adverse events ect.)
- Description of the device
- Checklist of Annex 7 of the Medical Device Registration Guideline (very similar to
Annex I of European Directive 93/42 EEC)
- Risk Assessment
- Biocompatibility studies
- Clinical studies
- Manufacturing process flow chart, master formula and sterilization method (if any)
- Special requirements for medical devices manufactured from or incorporating viable
or non-viable animal tissues or their derivatives: certifications (TSE certificate)
relevant to the source of the animal tissue or its derivative
- Stability studies for zone IV
- Lab (QC) files (specifications and analytical methods)
- Price certificate

79
GIORDANIA
(Rev. 0 – 2012)
registrazione:
3-4 mesi a partire dalla data della submission
della documentazione completa alla Autorità
Regolatoria
Tasse ministeriali: SI (circa 100 €)
Materiale di confezionamento: Inglese
Criticità Vengono richiesti i working standard e relativi
certificati d’analisi. Può essere richiesta la
colonna impiegata nella HPLC.
Requisiti per l’importazione: Per ogni lotto importato viene richiesto anche il
certificato d’origine.

80
Tab. 1 – documentazione richiesta
No. Required Documents Notes
1. Notarized copy of CE certificate,
OR
FDA certificate; legalized by:
- Ministry of Health
- Ministry of Foreign Affairs
- Jordanian Embassy
OR
FSC from the country of origin and FSC from one of the following countries:
- Switzerland
- Australia
- Japan
- Canada
- Norway
legalized by:
- Ministry of Health
- Ministry of Foreign Affairs
- Jordanian Embassy
CE Certificate
should indicate the
Annex of Directive
93/42 as amended
and the class, and
mention the name
of the product.
2. A composition certificate indicating active and inactive ingredients with their
specific percentage and function for each component. This certificate should
be signed and stamped by the manufacturing company.
3. Finished product specification at shelf life. This certificate should be signed
and stamped by the manufacturing company.
4. Attestation letter from the manufacturing company stating storage conditions
and shelf life which will be appear on the outer and inner label. This
certificate should be signed and stamped by the manufacturing company.
5. Certificate of analysis for the finished product carrying the same batch
number of the submitted samples. This certificate should be signed and
stamped by the manufacturing company.
6. Methods of analysis for finished product. These documents should be signed
and stamped by the manufacturing company.
7. Free from TSE / BSE certificate (declaration letter from the manufacturing
company stating that the product is free from any human or animal origin).
8. Ten Samples of the finished product.
9. Sample of the outer and inner label.
10. Sample of the inner leaflet, if available.
11. Catalogue, if available.

81
IRAN
(Rev. 0 – 2012)
registrazione:
12/24 mesi
Per registrare il prodotto, l’azienda produttrice
può doversi sottoporre ad una ispezione GMP
da parte del Ministero locale. Prima di tale
ispezione è possibile comunque ottenere un
permesso di importazione.
Tasse ministeriali: Per registrare ciascun prodotto: 400 € circa.
Per registrazione il produttore: 2000 € circa (a
cui si aggiungono dai 5000 - 8000 € circa in caso
di ispezione al sito di produzione da parte delle
Autorità locali)
Materiale di confezionamento: Persiano
Criticità Tra gli altri documenti vengono richiesti:
- Product Master File (breve dossier sul
dispositivo, vedi tab.1)
- Plant Master File (PMF), documento
analogo al Site Master File farmaceutico
- Product importing application form (PIAF)
contenente altre informazioni sul
dispositivo (vedi tab.2)
Alcuni documenti devono essere legalizzati dal
consolato.
Vengono richiesti il GMP, l’ISO 13485 ed il
E’ necessario nominare un distributore locale.

82
Tab. 1 – Product Master File
Brandname
Name and Company Address
Formulation
Physiochemical characteristics
Raw material monograph from pharmacopoeia or original company specification
Active ingredients certificates of analysis
Active ingredients methods of analysis
Excipient certificates of analysis and analytical methods
Ingredients’ function
Manufacturing method
Finished product microbial and physiochemical tests
Microbial and physiochemical tests methods
Microbial and physiochemical tests results
Stability tests
Methods of stability tests
Finished product certificates of analysis
Packing and specifications (weight, volume, size, type of container)
Physiochemical test for plastic container
Container compatibility
Label color and design
Storage conditions
Cautions and adverse reactions
Toxicology
References

83
Tab. 2 – Product Importing Application Form

89
IRAQ
(Rev. 0 – 2012)
- Boicott declaration (nei confronti dei paesi inclusi nella Boicott Black List, tra i quali
Israele)
- ISO 13485
- Autorizzazione alla produzione farmaceutica
- Registration form (vedi tab.2)
registrazione:
12 mesi
Tasse ministeriali: 1200 € circa per la registrazione del produttore.
consolato, con relativi costi e tempi. Vengono
richiesti il Certificato ISO 13485 e
l’Autorizzazione alla produzione farmaceutica.

90
Tab. 2 – Registration form for medical appliances & lab. Diagnostic kits
First: general information
- Name of company
- Main addess
- Nature of activities (contract manufacturer, market authorize holder, etc.)
- Number of various working branches inside country of origin
- Number of various working branches outside country of origin
- Name and address of branch supplying the Iraqi Market
If the branch supplying the Iraqi market is not the mother company, please fill separate
application for the mother company
- Name and address of other companies that cooperate or share in its activities in the field of
production, what sort of relation?
- Year of foundation
- Registered annual Capital
Working annual capital (optional)
Sales annual capital (optional)
- Total number of employee
- Are these products totally or partially manufactured by the firm itself ?
- If partially manufactured, what are these products, Where are manufactured, and Why?
- Other activities beside medical appliances.
- Name the countries where products are marketed.
Second: Production Division
- Origin of all raw materials
- Self manufacturing
- Under license
- Other sources
- Name the countries where products are marketed.
- Number of square meters assigned for production area.
- Name, qualification and signature of the head of the dept.
Third: Control Laboratories
- Do you have control laboratories?
For testing raw materials
For in-process control
For testing final products
- What type of laboratory tests you perform?
- What type of laboratory equipments used for quality control? (May be submitted separately)
- Number and qualification of personnel working in these labs?
- Do you revert the aid of other laboratories for control purposes? Name these labs, and indicate
what sort of assistance
- Number of square meters assigned for these labs
- Give in details the activities performed by the competent authorities controlling your
establishment and production.(provide details & documentation)
- Name, qualification and signature of the head of the dept.
I, the undersigned: (Full name of the person responsible for the establishment)
Hereby declare that all information are given above is true, and I assume full responsibility for this
declaration with all consequences, which might arise from false or erroneous information.

91
ISRAELE
(Rev. 0 – 2012)
Declaration of Foreign Manufacturer
CE Certificate
FDA Certificate (if present)
ISO 13485 /ISO 9001
Procedure di autorizzazione: Registrazione per tipologie di prodotti (es.
Orthopedics and Plastics)
registrazione:
12 mesi
Tasse ministeriali: 240 €
Materiale di confezionamento: Inglese e/o Ebraico (multilingua accettabile).
I prodotti per uso domestico (non
professionale) devono avere un foglietto in 3
lingue (ebraico - inglese - arabo) tradotto
dall’inglese originario.
Criticità E’ necessario nominare un distributore locale.
Viene richiesto il Certificato 13485.
Validità della registrazione: Definita sulla base della scadenza del
documento di riferimento (e.g. certificato CE,
ISO)

92
KUWAIT
(Rev. 0 – 2012)
Letter of appointment
Free Sale Certificate (FSC)
EC Certificates
ISO 13485 Certificate of all producers
Biocompatibility Report
Clinical Expert Report
Packaging
registrazione:
3 -4 mesi
Tasse ministeriali: n.d.
E’ necessario nominare un distributore
locale/agente esclusivo.
certificato ISO 13485 di tutti i produttori
coinvolti.
E’ richiesta documentazione a supporto di
sicurezza ed efficacia (e.g. report di
Biocompatibilità e clinical expert report)
E’ accettato il materiale di confezionamento
europeo, anche multilingua.
Requisiti per l’importazione: Fattura e dichiarazione d’origine legalizzate dal
consolato possono essere richieste per
l’importazione

93
LIBANO
(Rev. 0 – 2012)
ISO 13485 certificate
CE Certificates
Plant Profile
Composition certificate
Product characteristics
Stability data
Methods of analysis
Finished product specifications
Shelf life and storage conditions certificate
registrazione:
12/24 mesi
Tasse ministeriali: Non viene richiesto il pagamento di alcuna
tassa
Analisi di prodotto: SI (campioni di prodotto finito con relativi
metodi d’analisi)
Requisiti per l’importazione: NA

94
QATAR
(Rev. 0 – 2012)
Procedure di autorizzazione: Registrazione del prodotto ma anche
dell’azienda
registrazione:
8-12 mesi
Tasse ministeriali: ND
E’ necessario nominare un distributore
locale/agente.
E’ richiesto il certificato di libera vendita
E’ richiesta giustificazione dell’assenza
dell’autorizzazione alla produzione e
applicabilità del certificato ISO 13485.
E’ richiesta la dichiarazione di assenza di
“hormones, anabolic steroids, anti-
inflammatory steroids, psychotropic drugs,
alcohol, heavy metals, pathogenic bacteria and
fungi, pork & pork-derivatives”
E’ accettato il materiale di confezionamento
europeo, anche multilingua.
Requisiti per l’importazione: Validità del prodotto all’importazione non deve
essere inferiore ai 2/3 della shelf-life.

95
- Letter of authorization
- Short information on the product
- Legalized EC Certificates
- Legalized ISO 13485 Certificate + declaration on the absence of the manufacturing
license
- Legalized Free Sale Certificate (FSC)
- Quali-quantitative composition
- Certificate of analysis of the finished product
- World-wide regulatory status of the product
- Declaration on the CIF price
- Declaration that the product is free from hormones, anabolic steroids, anti-
inflammatory steroids, psychotropic drugs, pork and pork-derivatives, pathogenic
bacteria and fungi, alcohol and heavy metals
- Artworks
- Samples of finished product

96
SIRIA
(Rev. 0 – 2012)
Manufacturing Authorization
CE Certificates
ISO 13485 Certificates
Methods of analysis
registrazione:
12 mesi
Tasse ministeriali: 400 euro circa.
E’ richiesto il certificato ISO 13485 ed il
Requisiti per l’importazione: NA

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