D & C Act: Instrument intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human beings or animals,
as may be specified from time to time by the Central Government by notification in the
Official Gazette, after consultation with the Board.
As per USFDA - “An instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article, including a component
part, or accessory which is recognized in the official National Formulary, or the United
States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment, or prevention of
disease, in man or other animals, or intended to affect the structure or any function of
the body of man or other animals, and which does not achieve any of it's primary
intended purposes through chemical action within or on the body of man or other
animals and which is not dependent upon being metabolized for the achievement of
any of its primary intended purposes."
• By MDD 93/42
Medical device means any instrument, apparatus, appliance,
software, material or other article, whether used alone or in
combination, with or without software to be used specifically for
diagnostic and/or therapeutic purposes, to be used for human beings
for the purpose of:
– Diagnosis, prevention, monitoring, treatment or alleviation of disease,
( e.g. Urinary catheter)
– Diagnosis, monitoring, treatment, alleviation of or compensation for an
injury or handicap, ( e.g. Bone cement)
– Investigation, replacement or modification of the anatomy or of a
physiological process ( e.g. Hip replacement)
– Control of conception ( e.g. Condoms)
And which does not achieve its principal intended action in or on the
human body by pharmacological, immunological or metabolic means,
but which may be assisted in its function by such means.
Class-I (Low Risk):Elastic bandages , Examination Glove, Adult Incontinence Pad
Class –II (Medium Risk): Catheter Cannula, Dialyzer , Piston syringe , Needle,
Infusion Pumps, Bone fixation screw, Blood pressure Kit
Class-III (High risk): Pacemakers, Dental Lasers, Heart Valves.
Medical Devices are classified as per their risk level and intended use.
By CDSCO (IMRDA) & MDD- Risk Based classification
Class A (Class-I)– Devices involving low risk levels (Thermometer)
Class B (Class-II a)– devices involving low to medium risk (Hypodermic Needle)
Class C (Class-II b)– Devices involving moderate to high risk (Lung ventilator)
Class D (Class-III)– Devices involving high risk. (Heart valve, implantable device)
FDA ‘Approval Process’ by Class of Device
Class-1 Class-2 Class-3
No FDA approval needed*
Must register device &
company on FDA website.
FDA clearance required.
Typically via 510 (K)
FDA approval required.
Typically via Premarket
(PMA) approval process
Approval of Class-3 Devices is complicated and involves clinical trials.
Less than 10% of devices are considered Class-3 by the FDA.
* Most Class-1 devices are 510 (K) Exempt
How to determine classification?
Go to www.fd.gov./medicaldevices and search for “product classification” using their
search box. This will lead you to the product classification Database.
Note: You will also see a link to device classification near the bottom of this page.
Research devices using FDA website
Use the database to search for devices similar to your device, called
TIP: Use the most basic description of your devices to start your search. The FDA data base uses exact searched
so try both singular and plural searches. Use the search button & not go to quick search.
Review the various product description
TIP: Click on the name of devices that seems similar to your product and start reading about them
Determining your path to Compliance
TIP: The regulation number contains a link to a detailed description of the device.
Regulation number is very important
TIP: Read product description very carefully. Find the product most similar to yours.
Once you have determine classification…
Class-1 Class-2 Class-3
Register product using the
FDA .Gov website.
Proper product code will
Prepare a 510 (k)
application. Some products
require clinical data or
Develop clinical trials
protocols, get approved by
FDA, then prepare & submit
premarket approval (PMA )to
Length of the approval process
Less than one month.
You self registered product
& company online. Pay fee
FDA reviews most 510 (k)
application with in 90 days.
Entire process requires 4-10
months, depends on how
closely your product
matches the predicate
36 months or more,
depending o n extent of
clinical trials and additional
FDA information request.
FDA takes 180 days to review
Length for FDA review often depends on the quality of your submission! Don’t forget…..
Premarket Notification - also called PMN or 510(k).
• Class I, II, and III device intended for human use, for which a Premarket Approval
(PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from
510(k) requirements .
•Device manufacturers must notify FDA of their intent to market a medical device at
least 90 days in advance.
•Submitters must compare their device to one or more similar legally marketed
devices and make and support their substantial equivalency claims.
•This allows FDA to determine whether the device is equivalent to a device already
placed into one of the three classification categories
•Before marketing a device, each submitter must receive an order, in the form of a
letter, from FDA which finds the device to be substantially equivalent (SE) and states
that the device can be marketed in the U.S. This order "clears" the device for
Device must be registered on FDA. Gov website
Class-1 Class-2 Class-3
To registered you will need:
Proof of Payment.
Correct FDA product Code
To registered you will need:
Proof of Payment
510 (K) number issued by
To registered you will need:
Proof of Payment
PMA number issued by FDA
FDA will issue a 510 (k) number or PMA number. These numbers are required to
proceed with final registration step on FDA website.
Class-1 Class-2 Class-3
Most Manufacturers must comply with the FDA
Quality System Regulation (21 CFR part 820).
This is also known as good manufacturing practice (GMP).
Companies that outsource manufacturing must still comply. Supplier too!
FDA does not recognize ISO 13485 or ISO 9001 and does not certify quality system.
Instead FDA conducts Random Inspection for compliance with 21 CFR 820.
They do inspect class-3 device Manufacturer prior to PMA approval
FDA inspection can happen any time after online registration .
Manufacturers requires a quality system comply with
21 CFR part 820
•The Quality System Regulation (QS Reg)Effective on June 1, 1997 for medical devices.
•ISO 13485: 2003 and 21 CFR Part 820 are harmonized; Each may have additional
requirements but they do not conflict with one another.
•Subpart A—General Provisions
•Subpart B—Quality System Requirements
•Subpart C—Design Controls
•Subpart D—Document Controls
•Subpart E—Purchasing Controls
•Subpart F—Identification and Traceability
•Subpart G—Production and Process Controls
•Subpart H—Acceptance Activities
•Subpart I—Nonconforming Product
•Subpart J—Corrective and Preventive Action
•Subpart K—Labeling and Packaging Control
•Subpart L—Handling, Storage, Distribution, and Installation
•Subpart O—Statistical Techniques
21 CFR Part 820
Medical Device Approval In Europe (CE Certification)
Medical Devices (MDD) 93/42/EEC
Covers the bulk of medical devices marketed in the EU
Examples: orthopedic implants, heart valves, medical software
In Vitro Diagnostics (IVDD) 98/79/EC
Covers devices used for the examination of specimens taken from the human body
Examples: pregnancy self-testing strips, blood glucose self-testing strips
Active Implantable Medical Devices (AIMDD) 90/385/EEC
Covers devices that require external power sources in order to function properly
Examples: pacemakers, implantable defibrillators
EU Directives Impacting Medical Devices
•Manufacturers and Subcontractors
Key Players in the CE Marking Process
Competent Authorities are entities enforcing Medical Device
Directives at the national level in each EU member state.
EU member states and their Competent Authorities each have their own
interpretations of how Directives should be carried out. Manufacturers
seeking to sell in more than one EU member state should take this into account
Overview of the European Union
•27 member states plus European Free Trade Association members (Norway,
Switzerland, Iceland and Liechtenstein)
•Population of more than 500 million people
Notified Bodies are authorized to audit manufacturers’ quality systems and test
/review devices for compliance with applicable EU Directives and standards.
Notified Body responsibilities include:
•Advising on device classification and Conformity Assessment routes
•Pre-assessment of devices
•Product and quality system evaluation
•Concluding and evaluating manufacturers’ Corrective Actions
•Issuance of certifications
•Maintaining programmed surveillance of devices in the EU
Required for any firm without a location in the EU.
Authorized Representatives’ responsibilities may include:
•Liaising between manufacturers and Competent Authorities
•Listing their names on clients’ device labels and packaging
•Notifying Competent Authorities of manufacturers’ and devices’ names
•Keeping Technical Files/Design Dossiers available for review by Competent
•Participating in vigilance/post-market surveillance procedures
Basic Steps to Compliance in the EU
1. Identify Directives and Regulations appropriate for your device.
2. Classify your device according to MDD Annex IX
3. Implement Quality System in compliance with ISO 13485
4. Prepare Technical File or Design Dossier demonstrating
compliance with MDD 93/42/EEC.
5. Appoint your Authorized Representative.
6. Have Notified Body audit your Quality System and Technical File or Design
7. Register your device with Competent Authorities if necessary.
8. Prepare Declaration of Conformity and affix
CE Marking to your device
Step One: Classification/MDD Determination
First, determine which Medical Device Directive (MDD, AIMDD or IVDD) applies to
your device. Then determine device classification using Annex IX of MDD 93/42/EEC.
How Classification is Determined
MDD 93/42/EEC Annex IX contains 18 rules for medical device
classification based on factors including the following:
•Device’s intended use
•Active versus non-active functionality
•Device’s duration of contact with patient
•Degree of invasiveness
•Part of body contacted by device
Degree of Invasiveness Criteria
•Application to body surface versus
•Surgically invasive or non-invasive
Duration of Contact Criteria
•Less than 60 minutes = Transient
•Less than 30 days = Short-term
•More than 30 days = Long-term
Determining your device’s duration of contact and degree of invasiveness
will help determine how to classify the device
Quality System Manufacturers of Class I sterile/measuring, IIa, IIb and III devices
must implement quality management systems (QMS) (in compliance with Annex
II or V of the MDD).
Most manufacturers meet this requirement using ISO 13485.
Requirement of ISO 13485 (Quality System Requirements)
Phase I: Quality system preparation and development
Phase II: Implementation
Training, internal audit, CAPA
Phase III: Registration
Registration audit by notified body
Final ISO 13485 certification
Technical File/Design Dossier Preparation
Technical File Components
Technical File Components
Clinical Data Requirements
EU regulators have increased their requirements for clinical data even for Class I
medical devices in recent years.
•In many cases, manufacturers must submit Clinical Evaluation Summary Reports that
verify the safety and performance of their products along with Technical Files or Design
Manufacturers with no offices in the EU must appoint Authorized Representatives
(EC REPs) to interact with regulators on their behalf.
EC REP Responsibilities
•Registering your device with Competent Authorities before commercialization
•Serving as primary point of contact with all EU Competent Authorities
•Keeping a current copy of your Technical File/Design Dossier available for inspections
by Competent Authorities
•Authorizing you to place EC REP name and address on your device labels, packaging
and instructions for use
•Handling Incident and Field Safety Corrective Action (FSCA) reporting to Competent
•Representing you before the European Commission in the event that your product is
withdrawn in a member state
•Protecting the confidentiality of your product information
•Maintaining reports on clinical evaluation data for review by Competent Authorities
•Communicating with Competent Authorities on serious device incidents .
Device manufacturers must register with the Competent Authority of the country
where their EC REPs are based.
Notified Body Audit
Registration with Competent Authorities
Declaration of Conformity and CE Marking
In order to complete the CE
Marking process, all
manufacturers must prepare a
Declaration of Conformity stating
their device is in compliance with
all applicable Directives. Upon
completion of your Declaration of
Conformity, you may affix CE
Marking to your product.
Labeling and Language Requirements
EU member states MAY REQUIRE
labeling information be made available
in their local languages or another
European Community language to
patients and users in accordance with
Annex I, point 13 of the MDD.
Post-Market Surveillance (PMS) and Vigilance
•PMS required for all medical devices sold in the EU
•Manufacturers are required to develop proactive plans for PMS
•PMS plans should include reviews of market and field data, complaints
and corrective actions
•Systematic records of PMS findings must be kept
Import Registration of Medical devices in India under the
provisions of the Drugs & Cosmetic Act 1940 & Rules 1945.
India currently imports 70 per cent of its medical devices
At the federal (central or union) government level in India, medical device are
regulated by the Central Drug Standards Control Organization (CDSCO) under the
Ministry of Health and Family Welfare.
No regulations for medical devices in place prior to 2005.
The registration process for medical devices in India remains fluid, but regulators are
taking steps to develop a more formalized over sight policy.
The import, manufacturing ,distribution and sale of medical devices in India are
overseen by the Drugs and Cosmetics Act(1940) and Rules(1945).
22 Nos. medical devices are currently “notified” under the Drugs & Cosmetics Act.
Controls and inspections are carried out by the CDSCO, state drug controllers and
Non notified devices do not require CDSCO registration, and may be imported into
India according to formal customs rules.
Regulation for import medical devices
•Foreign and Indian companies will have to apply for permission to import medical
devices in India.
•Both manufacturer and third party(agent) will have to register with CDSCO.
•Indian importer or agent –obtain ‘no objection certificate’.
•If the medical device is already approved by USFDA or CE -> Device registration in India
will be trouble free.
For the import of medical devices in India, Registration Certificate in Form 41 and
Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act &
Requirements of Import License (Form 10): (2-3 months)
Self-attested copy of authorization letter
Notarized copy of Wholesale Licence or Manufacturing Licence of the Indian Agent
Copy of Registration Certificate in form-41
Documents as stated in Registration Certificate (In case of conditional certificate)
Notarized Labels of the device as per Rule 109 A of Drugs & Cosmetics Rules).
Indian FDA: http://www.cdsco.nic.in/forms/Default.aspx
Medical Device: http://cdsco.nic.in/Medical_div/medical_device_division.htm
Registration of Medical Devices in India
Requirements of Registration (Form 41):
I. From Manufacturer
A. Legal Documents
1. Power of attorney
2. Schedule D-I
3. Schedule D-II (Device Master file)
B. Regulatory Certificates
1. Plant Registration Certificate
2. Manufacturing & Marketing License
3. Free Sale Certificate/ Certificate of Foreign Govt. from the country of origin
4. Free Sale Certificate from anyone of the GHTF countries
5. US FDA clearance/approval
6. Certificate of Foreign Government
7. EU medical device directive (CE Certificate)
8. CE Declaration of Conformity
9. CE Design Certificate
10. CE full quality Assurance
11. Approval Certificates in any other country
12. ISO/EN-13485 Certification if any for the manufacturing facility
13. List of countries where the device is being sold
14. Domestic Price List
15. List of Quantities Sold of Products Sold in Various Countries for last 3 yrs (approximate)
E. PMS -DOSSIER
1. Post Market Surveillance files containing the following
2. Procedures for distribution of records
3. Complaint handling
4. Adverse incident reporting
5. Procedure for product recall
6. PMS Data & Corrective Actions Taken
F. Labels as per Rule 109 A of D&C act
G. Product Insert/IFU
H. Printed Company Profile & Catalogues
•A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for
a period of three years from the date of its issue.
•The requirements for Re-registration of Devices are remains same as fresh Registration
requirements except requirement of hard copy of Plant Master File (PMF) and Device
Master File (DMF) provided there are no changes in the PMF and DMF, However soft
copy of PMF and DMF in the form of compact disc shall be provided along with the
Changes happening to regulation of medical devices in
The Indian health ministry is planning significant changes to its regulatory
approach for medical devices. Revisions will include:
• Defining and regulating medical devices separately from drugs
• Bringing all medical devices under regulation in India ( more than 3000 nos.)
• Establishing a risk-based device classification system
• Establishing clinical trial protocols/ methodologies
• Setting up conformity assessment procedures
• Increasing staff and resources at the CDSCO
• Setting up medical device testing labs (Near Gandhinagar, Ahmedabad)
• Commencement of materovigilance program
• Self certification of medical devices (ISO 13485 Certification)
• The State Drug Licensing Authority called as Food and Drug Administration
(“FDA”), recently issued a letter to the DCGI and the National Pharmaceutical
Pricing Authority making a case for bringing medical devices under price control.
The Drug Price Control Order, 2013 (“DPCO”) which provides a framework for
controlling the prices of drugs.
• Medical Devices manufacturing hubs/ parks are planned with huge tax benefits &
single window clearance Medical park is inaugurated at Gujarat & second one in