Anvisa & INMETRO - Registering Non-Electrical Medical Devices in Brazil

S

sandieash

#1
Hi all,

We are medical manufacturing firm in Cape Town South Africa and would like to register in Brasil to be able to sell our Spinal System. I am not 100% sure if INMETRO is applicable to us as we do not manufacture an electrical product. We are currently certified by SGS against ISO13485, have CE mark and have 510(k) approval in USA.

I saw on one of the posts that SGS is one of the CB's that can do INMETRO certification. We have just completed a surveillance audit last week with SGS, with no problems and are due for the recertification next year. Do you think already having audits done by SGS may speed up the process, or would ANVISA still need to come out here to audit us?

thanks
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: Anvisa & INMETRO

Hello sandieash and welcome to the Cove!

I am not 100% sure if INMETRO is applicable to us as we do not manufacture an electrical product
Inmetro certification is not only for medical electrical products. Right now, it´s for condoms, syringe,s needles, infusion bags, and mammary implants.

I saw on one of the posts that SGS is one of the CB's that can do INMETRO certification.
This might be related to medical electrical certification.

Do you think already having audits done by SGS may speed up the process
No.

, or would ANVISA still need to come out here to audit us?
They will if you your device is under the registration process (classes II and IV and some class II).

For more info on all of this please, review the following threads:

- Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

- Medical Device Registration Process in Brazil - Anvisa
 
Thread starter Similar threads Forum Replies Date
R Medical Device Approval in Brazil - Understanding INMETRO and ANVISA Other Medical Device Regulations World-Wide 127
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 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 – 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 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
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
L ANVISA RDC 16 - purchasing records Other Medical Device Regulations World-Wide 2
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 133
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
P IVD Classification in Brazil and Anvisa Guidance Other Medical Device Regulations World-Wide 10
M Future revision of ANVISA RDC 59 - Brazilian GMP Other Medical Device Regulations World-Wide 14
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
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
J INMETRO process of Hypodermic Needle in Brazil Other Medical Device Regulations World-Wide 2
M Revision of INMETRO Portaria 350 - August 2014 Other Medical Device Regulations World-Wide 2
S Brazilian Standard Compliance for Writing Instruments - Inmetro RoHS, REACH, ELV, IMDS and Restricted Substances 2
Marc Medical Equipment Inmetro Certification Process in Brazil - Part 2 Other Medical Device Regulations World-Wide 3

Similar threads

Top Bottom