Apr 4, 2013

Brazilian Good Manufacturing Practice (BGMP) requirements for medical device manufacturers have been streamlined, potentially making BGMP compliance less complicated.

A new Good Manufacturing Practices regulation, RDC 16/2013, has gone into effect in Brazil, and replaces two prior BGMP resolutions, RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostic (IVD) devices. In other words, Brazilian regulators have put in place a single BGMP resolution for both medical device and IVD manufacturers; companies marketing higher-risk medical devices and IVDs in Brazil, as well as medical devices listed in Normative Instruction IN 02/11, now have only one set of BGMP requirements to meet, and may furthermore utilize a single BGMP inspection request instead of two separate ones for medical devices and IVDs. 

RDC 16/2013 is now in effect in Brazil. Companies have 180 days from the issuance date of 28 March 2013 to comply with the new regulation. Companies with ANVISA BGMP inspections scheduled within the 180 day timeframe should expect to be evaluated according to RDC 16/2013 requirements, but Brazilian regulators are providing a 180-day window for these firms to make quality system changes necessary for RDC 16/2013 compliance.

For companies currently holding BGMP certification, the new regulation will require them to update their quality systems in order to meet RDC 16/2013 compliance requirements prior to their recertification with ANVISA.

In related news, ANVISA has also selected 29 regional auditors in Brazil for promotion to ANVISA auditors who will focus on BGMP inspections of foreign companies.

The reallocation of these auditors is effective immediately, although these individuals must still undergo training to fulfill their new responsibilities. Once these new auditors are fully trained, their promotions may triple the number of people performing international BGMP audits for ANVISA.


  • Stewart Eisenhart