The regulatory road to market

Brazil Regulations Update
Qserve Conference 18-19 November 2013
Purmerend – Greater Amsterd...
Agenda
•

Geography

•

Key developments in Brazil

•

Health care system

•

Regulatory process for medical devices in Br...
Geography
•
•
•

•
•

Brazil is largest country in South
America, 5th largest in the world
Population of 200 Million 5th l...
Key developments in Brazil
Key developments in Brazil
Strengths

Weaknesses

• Positive economic conditions in the recent
years.
• Increased consumpt...
Health Care System in Brazil
•
•
•

•
•

Largest medical device market in Latin America.
The public health system (SUS), p...
Health Care System in Brazil
•

Private investment being encouraged through a public-private partnerships

•

Public secto...
Health care system in Brazil
The development of the economy is forcing reforms to improve and provide a good

health syste...
Regulatory process for medical devices in Brazil
National Health Surveillance Agency

National Institute of Metrology,
Sta...
Regulatory processes in Brazil


Medical Device Classification – RDC 185/01 is the primary regulation applicable

to the ...
Regulatory processes in Brazil
Appoint Brazilian Registration Holder

Who you can use to be your BRH?
set up your own comp...
Regulatory processes in Brazil
ANVISA´s GMP INSPECTION
 Manufacturer must submit application for ANVISA´s GMP inspection
...
Regulatory processes in Brazil
ANVISA´s GMP INSPECTION

•

Queue time for Anvisa´s GMP inspection is currently about 2 yea...
Regulatory processes in Brazil - INMETRO
Certification


Mandatory INMETRO certification
for most electrical Medical
Devi...
Regulatory processes - INMETRO Certification



Test report must not be older than 2 years – Ordinance 350/10






...
Regulatory processes – Anvisa Registration










Prerequisites



Manufacturing Description - Flow Chart

AN...
Regulatory processes – Anvisa Registration


Clinical Data, can be clinical trials or literature depending on the risk

...
Regulatory processes – Anvisa “Cadastro”
Manufactures of Class I and II devices not listed in IN 2/11 - RDC 24/09

 Regis...
Timelines
INMETRO Certification
About 1/2 month's

Lead Time Anvisa Inspection up to
24 months

Time between application f...
Additional remarks
Brazilian medical device market regulator ANVISA plans to
launch a two-year trial period to allow third...
Validation compliance Brazil
•
•
•
•
•
•
•

A new Good Manufacturing Practices regulation, RDC 16/2013, replaces two prior...
Summary/main conclusions

•
•
•

•

Current size and anticipated continued growth of the Brazilian market present
signific...
Thank you for your attention !
Sheila Jaime
sheila.jaime@qservegroup.com

www.qservegroup.com
Qserve Group B.V.
Asterweg 1...
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Latest update Brazil Regulations By S. Jaime - Qserve Group (Qserve Conference 2013)

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Latest update Brazil Regulations By S. Jaime - Qserve Group (Qserve Conference 2013)

  1. 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. 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. 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.
  4. 4. Key developments in Brazil
  5. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 Page 20 | 2013 |Copyright Qserve Group B.V.
  21. 21. Validation compliance Brazil • • • • • • • 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 Page 21 | 2013 |Copyright Qserve Group B.V.
  22. 22. Summary/main conclusions • • • • 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. Page 22 | 2013 |Copyright Qserve Group B.V.
  23. 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.
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