ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022

L

liuyy

Involved In Discussions
#1
#1
RESOLUÇÃO RDC Nº 665, DE 30 DE MARÇO DE 2022
Dispõe sobre as Boas Práticas de Fabricação de Produtos Médicos e Produtos para Diagnóstico de Uso In Vitro.
ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
M

Mrs Dean

Registered
#2
#2
liuyy said:
RESOLUÇÃO RDC Nº 665, DE 30 DE MARÇO DE 2022
Dispõe sobre as Boas Práticas de Fabricação de Produtos Médicos e Produtos para Diagnóstico de Uso In Vitro.
ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022
Click to expand...
Hi there!
Good day.

We are a Class III medical device manufacturer in Malaysia, and would like to market our products in Brazil. We have our ISO 13485 certificate ready but do we still need to apply for BGMP? It's a bit confusing here.

Hope you can help us, thanks!
 
kys123

kys123

Starting to get Involved
#3
#3
Mrs Dean said:
Hi there!
Good day.

We are a Class III medical device manufacturer in Malaysia, and would like to market our products in Brazil. We have our ISO 13485 certificate ready but do we still need to apply for BGMP? It's a bit confusing here.

Hope you can help us, thanks!
Click to expand...
Yes, you will still need an authorized importer here in Brazil to apply for the BGMP for you.

Another very cool fact is that the BGMP is only valid for that importer, so if another company wishes to market your products, they will also have to apply and pay for the BGMP certificate (15k-ish USD today).

Unless you choose use a company that offers a registration hosting service and allows other companies to use their Anvisa registrations.
 
Last edited:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Y Gap assessment comparing RDC ANVISA 665/2022 and RDC ANVISA 16/2013? Other Medical Device Related Standards 0
M Informational ANVISA regulation for personalized/custom medical devices – RESOLUÇÃO – RDC Nº 305, DE 24 DE SETEMBRO DE 2019 Medical Device and FDA Regulations and Standards News 0
M Informational ANVISA – Notification for Class 1 devices – Resolução da Diretoria Colegiada – RDC nº 270 de 28/02/2019 Medical Device and FDA Regulations and Standards News 0
L ANVISA RDC 16 - purchasing records Other Medical Device Regulations World-Wide 2
M Future revision of ANVISA RDC 59 - Brazilian GMP Other Medical Device Regulations World-Wide 14
kys123 Implications of failing an Anvisa Audit for ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
P Brazil - ANVISA - distance selling Other Medical Device Regulations World-Wide 0
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 1
M Informational ANVISA – CONSULTA PÚBLICA Nº 734, DE 22 DE OUTUBRO DE 2019 – Registro de dispositivos médicos para diagnóstico in vitro (in vitro diagnostic medical m Medical Device and FDA Regulations and Standards News 0
M Informational ANVISA – CONSULTA PÚBLICA No 730, DE 14 DE OUTUBRO DE 2019 – Registro de dispositivos médicos (Public consultation – registration of medical devices) Medical Device and FDA Regulations and Standards News 0
M Informational ANVISA – Aberta inscrição para evento sobre dispositivos médicos (ANVISA medical devices day event) Medical Device and FDA Regulations and Standards News 0
M Informational ANVISA – NOTA TÉCNICA 001/2019/GEMAT/GGTPS/ANVISA – Assuntos de Petições da Gerência de Tecnologia de Materiais de Uso em Saúde Medical Device and FDA Regulations and Standards News 0
B MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record Other Medical Device Regulations World-Wide 3
M Informational ANVISA – INSTRUÇÃO NORMATIVA N° 32, DE 12 DE ABRIL DE 2019 – Delegação da inspeção para verificação das Boas Práticas de Fabricação – Delegation of in Medical Device and FDA Regulations and Standards News 0
A How should the Medical Device OEMs be declared to ANVISA? Other Medical Device Regulations World-Wide 0
M Medical Device News Disponibilizados textos das CPs 584, 585 e 585 da ANVISA Medical Device and FDA Regulations and Standards News 0
M Medical Device News ANVISA – Consulta Pública nº 586 de 20/12/2018 – Diretrizes de Garantia da Qualidade para Validação, Monitoramento e Controle de Rotina dos Processos Medical Device and FDA Regulations and Standards News 0
M Medical Device News ANVISA – Consulta Pública nº 585 de 20/12/2018 – Boas Práticas para o Processamento de Produtos utilizados na assistência à saúde Medical Device and FDA Regulations and Standards News 0
M Medical Device News ANVISA – Consulta Pública nº 584 de 20/12/2018 – Enquadramento de dispositivo médico como de uso único ou reutilizável Medical Device and FDA Regulations and Standards News 0
M Medical Device News New ANVISA health services public consultations – Consultas públicas de serviços em saúde Medical Device and FDA Regulations and Standards News 0
R Are the ISO Standards actually required for health product registration on ANVISA? Other Medical Device Regulations World-Wide 4
pittmatj Brazil - Electronic Registration with ANVISA Other Medical Device Regulations World-Wide 10
S Is ANVISA site certification not required for Class I and II devices ? Other Medical Device Regulations World-Wide 1
L Reporting changes to ANVISA Other Medical Device Regulations World-Wide 24
B Brazil ANVISA Medical Device Labeling/IFU Requirements Other Medical Device Regulations World-Wide 1
pittmatj ANVISA Import Permit for Brazilian Customs Other Medical Device Regulations World-Wide 1
O List of ANVISA Registered Companies Other Medical Device Regulations World-Wide 1
O Implementation of GMP - Technical files for ANVISA Registration Other Medical Device Regulations World-Wide 3
M Informational Medical Device Registration Process in Brazil - Anvisa (Part 3) Other Medical Device Regulations World-Wide 134
K Would ANVISA (Brazil) inspect our new manufacturing site? Other Medical Device Regulations World-Wide 12
AnaMariaVR2 ANVISA Considers Accepting Foreign GMP Certifications US Food and Drug Administration (FDA) 0
B ANVISA B-GMP Inspection Schedule Other Medical Device Regulations World-Wide 4
Ajit Basrur Statement of Cooperation Among FDA - TGA - ANVISA - HPFB 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Medical Device Registration Process in Brazil - Anvisa (Part 2) Other Medical Device Regulations World-Wide 71
AnaMariaVR2 ANVISA Strike to Delay Medical Device Reviews in Brazil Other Medical Device Regulations World-Wide 2
S Anvisa & INMETRO - Registering Non-Electrical Medical Devices in Brazil Other Medical Device Regulations World-Wide 2
P IVD Classification in Brazil and Anvisa Guidance Other Medical Device Regulations World-Wide 10
C Anvisa Manufacturer Audit - Product produced at two different Sites Other Medical Device Regulations World-Wide 3
E Cross Reference Matrix for TGA and ANVISA requirements Other Medical Device Regulations World-Wide 3
R Medical Device Approval in Brazil - Understanding INMETRO and ANVISA Other Medical Device Regulations World-Wide 127
B IVD ANVISA Registration Process in Brazil and Registration Change Other Medical Device Regulations World-Wide 11
R Registering Medical Device in Brazil ANVISA - Fee Structure Other Medical Device Regulations World-Wide 1
S Who pays Brazil ANVISA Inspection Fees Other Medical Device Regulations World-Wide 38
S ANVISA Audit by 3rd Party? Other Medical Device Regulations World-Wide 4
A Material Grade Change Notification to Brazil ANVISA Other Medical Device Regulations World-Wide 2
Mikilk B-GMP Audit (Anvisa Brazil) - Checklist in English or other useful documents wanted Other Medical Device Regulations World-Wide 6
N ANVISA Inspection / Audit - French Company - China Manufacturing - Brazil Distributor Other Medical Device Regulations World-Wide 7
M ISO 14971 becomes mandatory in Brazil - ANVISA Normative Instruction 13/2009 ISO 14971 - Medical Device Risk Management 23
M Medical Device Registration Process in Brazil - Anvisa (Part 1) Other Medical Device Regulations World-Wide 301

Similar threads

Top Bottom