The document discusses regulations for medical devices in Brazil, including the country's healthcare system and regulatory approval process. It outlines key steps such as classification, appointing a Brazilian registration holder, ANVISA GMP inspection, INMETRO certification, and ANVISA registration. The lengthy overall process and importance of understanding regulatory changes and working with a local partner are emphasized.
Brazil International Ltd. is a boutique company that provides business
services for companies in the medical device field, seeking to
successfully penetrate and participate in the Brazilian market.
Brazil International Ltd. is a boutique company that provides business
services for companies in the medical device field, seeking to
successfully penetrate and participate in the Brazilian market.
Establishment, organization and the role of EFMHACAkidane Michael
Health services and products are the most stringently regulated in the world.
The current regulation represents the distilled wisdom of past experiences.
Having safe and quality products and services is a corner stone for public health
Ethiopian Food, Medicine and Healthcare Administration and Control Authority was established since 2010. IT replaces the former DACA; which was responsible to regulate medicine only.
EFMHACA is a federal science based law enforcement authority mandated to protect the public health and safety
Established by Council of Ministers Regulation No. 189/2010
Established as an autonomous government office having its own legal personality
Accountable to Ministry of Health
Head office at Addis Ababa and may have branch office else where, as may be necessary
Objectives
To protect the health of consumers by ensuring:
Food safety and quality
Safety, efficacy, quality and proper use of medicines
Competence and ethics of health professionals
The standards of health institution and
The hygiene and environmental health protection suitability for individuals and community health
Mission Statement
To promote and protect the public health by ensuring safety and quality of products and health service through
registration, licensing and inspection of health professionals, pharmaceuticals & food establishments, and health facilities and
provision of up-to-date regulatory information
promoting rational medicines use
Organized regulation started since 1960s
Health Sector Reform [in 2008]; which scrutinizes all regulatory components together
Mandate were divided into [in 2009)
Federal regulatory body
Regional regulatory bodies
Mandala International PDF brochure for Regulatory Affairs, Quality Assurance and Product Registration services for COFEPRIS (Mexico)
Our services:
Product Registration; License Holding
GMP Certification; Quality Assurance
Pharmacovigilance
GAP Analysis
Distributor Search; Market Research; Business Development
Mandala International is world's leading company for COFEPRIS (Mexico) Product Registration.
For more information email me at: david.ortega@mandala-intl.com
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REGISTRATION.VN helps you to have an overview of the regulations and procedures relating to registration of the products managed by Vietnamese Ministry of Health (such as registration of foreign companies doing Medicine business, drug registration, quota to import raw materials for medicines, registration for food supplements, cosmetics, medical equipment ...)
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Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Establishment, organization and the role of EFMHACAkidane Michael
Health services and products are the most stringently regulated in the world.
The current regulation represents the distilled wisdom of past experiences.
Having safe and quality products and services is a corner stone for public health
Ethiopian Food, Medicine and Healthcare Administration and Control Authority was established since 2010. IT replaces the former DACA; which was responsible to regulate medicine only.
EFMHACA is a federal science based law enforcement authority mandated to protect the public health and safety
Established by Council of Ministers Regulation No. 189/2010
Established as an autonomous government office having its own legal personality
Accountable to Ministry of Health
Head office at Addis Ababa and may have branch office else where, as may be necessary
Objectives
To protect the health of consumers by ensuring:
Food safety and quality
Safety, efficacy, quality and proper use of medicines
Competence and ethics of health professionals
The standards of health institution and
The hygiene and environmental health protection suitability for individuals and community health
Mission Statement
To promote and protect the public health by ensuring safety and quality of products and health service through
registration, licensing and inspection of health professionals, pharmaceuticals & food establishments, and health facilities and
provision of up-to-date regulatory information
promoting rational medicines use
Organized regulation started since 1960s
Health Sector Reform [in 2008]; which scrutinizes all regulatory components together
Mandate were divided into [in 2009)
Federal regulatory body
Regional regulatory bodies
Mandala International PDF brochure for Regulatory Affairs, Quality Assurance and Product Registration services for COFEPRIS (Mexico)
Our services:
Product Registration; License Holding
GMP Certification; Quality Assurance
Pharmacovigilance
GAP Analysis
Distributor Search; Market Research; Business Development
Mandala International is world's leading company for COFEPRIS (Mexico) Product Registration.
For more information email me at: david.ortega@mandala-intl.com
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
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Taipei, Taiwan
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Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
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As you start to map out your global strategy beyond the US, Canada and Europe, there are six key steps to follow and multiple regulations to consider. Harmonization has increased in recent years, yet most countries still maintain distinct medical device regulatory systems. Careful analysis on a market-by-market basis will help you to fully realize compliance requirements affecting a particular market. Explore these six steps as we reveal insights into the unique medical device regulations affecting markets in Russia, Brazil, Japan, China, and India.
This UL white paper reviews Brazil’s current regulatory framework for medical
devices, and the requirements for those entities seeking to manufacture, import or
sell medical devices in the country. It also discusses the registration and certification
process required of all device manufacturers, importers and distributors, and the
steps necessary to secure and maintain approval for medical devices. This white
paper includes information on requirements found in RDC 27/IN-3 and Resolution 350,
published by Brazilian regulatory authorities in June 2011.
INDIA MEDICAL DEVICE REGULATORY LANDSCAPEInsights10
The Indian medical device regulatory landscape is constantly evolving. In recent years, the government has implemented several new regulations to improve the safety and quality of medical devices. This has created new challenges and opportunities for medical device manufacturers and importers. To get a detailed report, contact us at - info@insights10.com, visit - https://bit.ly/3T4fMvE
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
Webinar: "The future of European Medical Device Regulations"pi
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Presentation from our webinar on the 1st June 2016, concerning the future of the European Medical Device Regulations.
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Kyiv PMDay 2024 Summer
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Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
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"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
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Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
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Latest update Brazil Regulations By S. Jaime - Qserve Group (Qserve Conference 2013)
1. The regulatory road to market
Brazil Regulations Update
Qserve Conference 18-19 November 2013
Purmerend – Greater Amsterdam
Page 1 | 2011 |Copyright Qserve Group B.V.
2. Agenda
•
Geography
•
Key developments in Brazil
•
Health care system
•
Regulatory process for medical devices in Brazil
•
Validation compliance
•
Additional remarks
•
Summary/main conclusions
Page 2 | 2013 |Copyright Qserve Group B.V.
3. Geography
•
•
•
•
•
Brazil is largest country in South
America, 5th largest in the world
Population of 200 Million 5th largest
worldwide
Capital is the city of Brasília, main cities
are:
São Paulo ( 11 Million citizens )
Rio de Janeiro (6 Million citizens)
Brazil is ruled by the Federal Presidential
Representative Democratic Republic
6th largest economy in 2012.
GDP : US $ 12.800 , growth: 2,34 %
( Netherlands: US $ 42.300,-)
Page 3 | 2013 |Copyright Qserve Group B.V.
5. Key developments in Brazil
Strengths
Weaknesses
• Positive economic conditions in the recent
years.
• Increased consumption power by C/D class.
• Low risk country (ranked as 3rd most
attractive country for foreign investment).
• Adaptability, creativity and flexibility.
• Empire of laws / heavy bureaucracy,
enormous public spending.
• Corruption incentive due to customs , tax &
legal system.
• Regional inequalities.
• Structural barriers to growth.
Opportunities
Threats
• Economic development forcing reforms.
• FIFA World Cup in 2014, Olympic Games in
2016 and Pre Salt development (Brazil as the
6th world major oil reserve) will ramp
investments in infra-structure.
• World player ambitions demand open
economy.
• Brazil will be the China (GDP growth
velocity) of the next decade (2010-20),
becoming the #5 world’s economy.
• Possible Global Recessions.
• Low pace of reforms bottlenecks economic
growth.
• China dependency.
Page 5 | 2013 |Copyright Qserve Group B.V.
6. Health Care System in Brazil
•
•
•
•
•
Largest medical device market in Latin America.
The public health system (SUS), provides healthcare services for all Brazilians
citizens
The majority of inpatient services within the SUS are operated by private
providers, with more than two-thirds of hospital facilities operated by the
private sector.
Brazil has the second largest private health insurance sector in the Americas,
after the USA, covering around 25% of the population
The expansion of the private health insurance sector in recent years has resulted
in demand for better medical care and, in turn, further expenditure in medical
equipment.
Page 6 | 2013 |Copyright Qserve Group B.V.
7. Health Care System in Brazil
•
Private investment being encouraged through a public-private partnerships
•
Public sector continues to be modernized and to upgrade
•
The government is extending healthcare service access through its Mais Saúde
programme.
•
Invest in SUS expanding: 2013: Reais 2.3 billion (US$1.1 billion) to support the
development of primary health and emergency care services.
Page 7 | 2013 |Copyright Qserve Group B.V.
8. Health care system in Brazil
The development of the economy is forcing reforms to improve and provide a good
health system to all people covering the whole country and not only the major
economic centers as Sao Paulo and Rio de Janeiro.
Page 8 | 2013 |Copyright Qserve Group B.V.
9. Regulatory process for medical devices in Brazil
National Health Surveillance Agency
National Institute of Metrology,
Standartization and Industrial Quality
Registration of medical devices and
maintenance of a registered products
database Brazilian GMP audit
National accreditation body.
Some electronic medical devices
must obtain INMETRO
certification as part of the
Brazilian registration process.
Page 9 | 2013 |Copyright Qserve Group B.V.
10. Regulatory processes in Brazil
Medical Device Classification – RDC 185/01 is the primary regulation applicable
to the registration of all medical devices, risk based classification, subdivided in
four classes similar to the Annex IX 93/42/EEC
RDC 185/01
I
II
III
IV
93/42/EEC,
Annex IX
I
IIa
IIb
III
RDC No. 185 describes
the applicable device registration protocol and lists the
documents required to legally register a medical device in Brazil.
Early classification of medical devices required
Page 10 | 2013 |Copyright Qserve Group B.V.
11. Regulatory processes in Brazil
Appoint Brazilian Registration Holder
Who you can use to be your BRH?
set up your own company
use a distributor
•
•
•
•
•
•
use an independent firm
•
Responsibilities of BRH
Provide authorization as local entity
on the device registration to Anvisa
Request the GMP inspection, if
applicable
Submit GMP self-inspection reports, if
applicable, to Anvisa
Hold INMETRO certificates
Give permission for distributors to
import products
Coordinate inquiries, analysis and
response for reportable events and
recalls
Assist in renewal and modifications of
device registrations
Page 11 | 2013 |Copyright Qserve Group B.V.
12. Regulatory processes in Brazil
ANVISA´s GMP INSPECTION
Manufacturer must submit application for ANVISA´s GMP inspection
Payment of fee in advance: R$ 37.000,00 (approximately US $ 16.500,00) per
site
New regulation: Publication of RDC 16/13 covering ANVISA´s GMP
requirements for Medical Devices and IVDs
RDC 16/13 replaces RDC 59/00 and Portaria 686 (IVDs)
GMP inspections are mandatory for manufactures of class III and IV devices
and class I/II devices listed in IN2/11
Once GMP compliance has been established, ANVISA conducts GMP
inspections every two years.
Manufacturers must self-audit every alternating year and submit report to
Anvisa
ANVISA registrations are valid for five years.
Audit are currently only performed by ANVISA – no Third Party authorized
Page 12 | 2013 |Copyright Qserve Group B.V.
13. Regulatory processes in Brazil
ANVISA´s GMP INSPECTION
•
Queue time for Anvisa´s GMP inspection is currently about 2 years
•
After successful inspection, Anvisa issues an Inspection Certificate which is
prerequisite for later medical device registration
•
Manufactures of Class I and II devices not listed in IN 2/11 are exempt from
Brazilian GMP inspections
•
Market access according to the Cadastro Process RDC 24/09
Page 13 | 2013 |Copyright Qserve Group B.V.
14. Regulatory processes in Brazil - INMETRO
Certification
Mandatory INMETRO certification
for most electrical Medical
Devices under the scope of
standards as listed in IN 3/11 mostly similar IEC or ISO
INMETRO Exemptions
Medical devices for which no test
capabilities within Brazil are available
such as Magnetic Resonance Devices
and Computer Tomography Scanner
standards
Some none electrical medical
devices
e.g. Gloves, Male Condoms, infusion
sets, needles , syringes
Page 14 | 2013 |Copyright Qserve Group B.V.
15. Regulatory processes - INMETRO Certification
Test report must not be older than 2 years – Ordinance 350/10
Must be completed prior to registration at ANVISA – RDC 27/11
After successful completion of Documentation Review and Pre-license
Inspection, certification is accepted
Annual factory inspection in order to maintain INMETRO Certification
INMETRO Certifications is valid for 5 years
For Re certification after 5 years, the Medical Device has to be completely retested even if it has not been changed
Page 15 | 2013 |Copyright Qserve Group B.V.
16. Regulatory processes – Anvisa Registration
Prerequisites
Manufacturing Description - Flow Chart
ANVISA´s Inspection Certificate
INMETRO Certificate – if applicable
Complete set of documentation according to RDC 185/01
Content of documentation according to RDC 185/01
Registration Form
Instructions for use in Portuguese
Technical Report: technical and scientific data regarding device safety
Manufactures letter authorization for a Brazilian legal entity to register, import
and distribute the product
Page 16 | 2013 |Copyright Qserve Group B.V.
17. Regulatory processes – Anvisa Registration
Clinical Data, can be clinical trials or literature depending on the risk
Proof of home market approval / Free sales Certificate
Alternatively proof of two other marketing approvals and explanation for no
home market approval
List of all accessories
Economic Information Report can also be required for some medical devices,
(cardiovascular products, implantable medical devices), information about
lifetime, pricing in other markets, number of patients per year – RDC 185/06
Specific documentation regarding the device can also be requested by ANVISA
Page 17 | 2013 |Copyright Qserve Group B.V.
18. Regulatory processes – Anvisa “Cadastro”
Manufactures of Class I and II devices not listed in IN 2/11 - RDC 24/09
Registration Form
Technical Report
Payment of fee
Timeline: approx.. 3months
Page 18 | 2013 |Copyright Qserve Group B.V.
19. Timelines
INMETRO Certification
About 1/2 month's
Lead Time Anvisa Inspection up to
24 months
Time between application for
GMP Inspection and execution of
inspection / issuance of certificate
by Anvisa
Anvisa Review
Time up to 12
months
(depending on
classification, risk,
complexity of product)
Page 19 | 2013 |Copyright Qserve Group B.V.
20. Additional remarks
Brazilian medical device market regulator ANVISA plans to
launch a two-year trial period to allow third-party audits of
Brazilian Good Manufacturing Practice (B-GMP) quality
systems.
ANVISA has set a tentative
start date of January 2014
for the trial; the US,
Canada, Brazil and
Australia are expected to
participate, meaning that
third-party certifiers
would be able to audit a
manufacturer’s quality
system for US, Canadian,
Brazilian and Australian
requirements at the same
time.
Although third-party
inspectors will be able
to perform B-GMP
audits, they will not
issue B-GMP
certificates. The
inspectors will instead
provide reports to
ANVISA, and the
regulator will then issue
final certification to the
manufacturer in
question.
This auditing program is
intended to be an additional
option for companies that
require B-GMP quality
management
System inspections; the
“normal” process of
requesting and receiving
inspections directly from
ANVISA will continue to be
available
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21. Validation compliance Brazil
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A new Good Manufacturing Practices regulation, RDC 16/2013, replaces two prior
BGMP resolutions, RDC 59/2000 for medical devices and Ordinance 686/1998 for in
vitro diagnostic (IVD) devices
Classification has impact on timeline: Complete registration process or cadastro
When applying for ANVISA GMP Inspection, the time on line has to be considered
ANVISA has published RDC 39/2013, issuing GMP certificates as well as Certifications
of Good Distribution Practices.
In addition, RDC 39/2013 allows foreign companies to change addresses of facilities
listed in applications for GMP certification, provided their applications have not yet
been reviewed by ANVISA.
INMETRO Safety certification for medical devices with electrical and other
components has changed in Brazil.
Foreign manufactures in the process of appointing BRH partners for devices that
must undergo INMETRO testing and certification should therefore verify that any
potential in-country representation partner can properly obtain INMETRO
certification as well as manage ANVISA registration
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22. Summary/main conclusions
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Current size and anticipated continued growth of the Brazilian market present
significant opportunities for manufacturers of medical devices.
The length of time between filing an application for a registration of a medical
device and the final government approval can be lengthy.
Medical device manufacturers can ease the process of gaining access to this
lucrative market by understanding the similarities and differences between
Brazil’s medical device approval scheme and the ones used in other major
markets. Staying informed of anticipated changes in regulations provide valuable
time to develop alternative plans and strategies for gaining and maintaining
market access.
Finally, working with an experienced and knowledgeable company in Brazil can
smooth the compliance process and mitigate setbacks from unanticipated issues
and challenges.
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23. Thank you for your attention !
Sheila Jaime
sheila.jaime@qservegroup.com
www.qservegroup.com
Qserve Group B.V.
Asterweg 19 D12
1031 DL Amsterdam
The Netherlands
T +31 (0)20 78 82 630
E info@qservegroup.com
Page 23 | 2013 |Copyright Qserve Group B.V.