Can ISO be used in place of ANVISA?

Yes, under certain circumstances, you can use your ISO 13485 certificate to temporarily meet B-GMP requirements to have your registration reviewed by ANVISA, and bypass a lengthy B-GMP inspection queue.

What is Cadifa Brazil?

At the end of a successful review, the DIFA holder will receive a certificate of suitability from ANVISA. This certificate is called a CADIFA (Carta de Adequabilidade do Dossiê de Insumo Farmacêutico Ativo) which is equivalent to the Certificate of Suitability (CEP) in Europe.

What is the FDA equivalent in Brazil?

The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others.

Does ANVISA require Mdsap?

Brazilian medical device market regulator ANVISA has officially extended applicability of the Medical Device Single Audit Program (MDSAP) to domestic manufacturers as well as other companies based in South America.

What is the difference between DMR and DHF?

In simple terms, a DHF (Design History File) marks the start of a particular device and documents how an OEM arrived at the final design. A DMR (Device Master Record) details the specific material, equipment, and environment requirements for production.

What is ANVISA’s BioQuant certification?

ANVISA certified that Swiss BioQuant meets the agency’s stringent biopharmaceutical safety guidelines allowing the company to conduct bioanalytical work on its clients drug products that will be marketed in Brazil. The certification will be valid until April 2019 and has been published on ANVISA website…

What is the new BGMP certification process from ANVISA?

A Normative Instruction from ANVISA is anticipated that will provide additional details on how the new BGMP certification process will work. Brazilian medical device regulator ANVISA has published updated requirements allowing for quality management system certification for some higher-risk devices without on-site inspections.

What is the new ANVISA Normative Instruction (in 04/2015)?

The new ANVISA normative instruction, IN 04/2015, replaces IN 11/2014, and updates compliance timeframes for various IEC 60601 standards. Two major updates are included in the new instruction.