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Companies that want to sell medical devices or IVD products in Brazil must comply with Brazilian Good Manufacturing Practice (GMP) quality system requirements. The requirements for medical devices are specified in Brazilian resolution RDC 16/2013.
In 2009, Brazil's regulatory agency (ANVISA) issued a resolution, RDC 25/2009, that made Brazilian GMP certification mandatory for many medical device manufacturers starting May 22, 2010. With ANVISA’s release of RDC 15/2014, B-GMP certification is only required for Class III and IV medical device and IVD manufacturers.
ANVISA conducts inspections of domestic and foreign medical device manufacturers in order to determine compliance with Brazil GMP regulations. ANVISA will only approve the registration upon successful completion of an audit. For more details on the ANVISA approval process, see our regulatory chart.
Brazil's GMP regulations most closely resemble the internationally recognized ISO 13485 standard.
Emergo Group maintains an office in Brazil and we can fully assist you with modifying your existing US FDA GMP or ISO 13485 compliant quality management system to meet Brazil GMP requirements. In addition, our medical device consulting team in Brazil has experience with a wide range of devices.
Whether you are entering Brazil for the first time or introducing a new device, Emergo Group has in-depth knowledge of the Brazilian regulations with the added benefit of a local consulting team in Brazil.
What kind of products require ANVISA Good Manufacturing Practices inspection, will my company need this?
All Class III and IV medical devices require an inspection of the relevant manufacturing sites before ANVISA will approve the registration. As a shorthand, Brazil Class III and IV products are generally aligned to Europe Class Class IIb and III devices.
I have heard that ANVISA allows third party organizations to audit to B-GMP. Is this true?
Not at this time. However, Brazil is a member of the International Medical Device Regulators Forum (IMDRF) Medical device single audit program (MDSAP) Working Group, along with Canada, Australia and the USA. This auditing program is intended to be an additional option for companies which require B-GMP quality management system inspections; the “normal” process of receiving inspections directly from ANVISA will continue to be available.
I have heard that ANVISA changed Brazil GMP requirements in 2014. What were the implications?
Yes, that’s correct. ANVISA released RDC 15/2014, and the major implication of this is that now Class I and II devices are exempt from requiring B-GMP certification. This means that all Class I and II medical devices and IVDs can submit their registration without any onsite quality system certification, although companies still do need to comply with B-GMP requirements. Overall, less costs and timeline to market for manufacturers of low to medium-low risk products.