Aug 20, 2013

Update 09/12/2013: ANVISA has published modified information regarding Decree No. 8077/2013 without mentioning BGMP exemption, but stating that specific sanitary regulations will apply. In the future, Brazilian regulators may be more selective in determining BGMP requirements based on individual devices' risk profiles, but for now compliance with RDC 25/2009 is still required.

Two new regulations targeting quality management system compliance for medical device manufacturers have gone into effect in Brazil. Although the new regulations do clarify some ongoing questions about how Brazilian Good Manufacturing Practice (BGMP) requirements are applied, they also raise new quality system compliance questions for medical device companies.

First, Brazilian medical device market regulator ANVISA has published RDC 39/2013 to deal with administrative processes for issuing BGMP certificates as well as Certifications of Good Distribution Practices. BGMP certificates will now be issued for separate product lines in each establishment. In accordance with Article 25 of the Regulation, the two product lines include one for materials and equipment (i.e., “medical devices”) and one for in vitro diagnostics, excluding IVD equipment (i.e., “IVDs”). If a medical device and an IVD are produced in a single manufacturing facility, that manufacturer will need to pay two separate BGMP fees for each of the two product lines. Furthermore, BGMP certifications will describe each production line in terms of risk classes.

In addition, RDC 39/2013 allows foreign companies to change addresses of facilities listed in applications for BGMP certification, provided their applications have not yet been reviewed by ANVISA.

Second, Brazilian president Dilma Rousseff has issued Decree No. 8077/2013 to replace Decree No. 79.094 as well as Decree 3961/2001. The new Decree harmonizes Brazilian laws governing medical products and services. Most importantly, Decree No. 8077 removes the section requiring mandatory presentation of BGMP certification to ANVISA in order to register some medical devices. This move suggests that ANVISA will take a more selective approach to determine which types of devices require BGMP certification for commercialization in Brazil.

Marcelo Brisolla, Emergo Group’s managing director in Brazil, expects a significant impact of these new regulations on the Brazilian market that will require careful consideration by medical device companies active in the region, particularly in terms of compliance with BGMP quality system requirements.

“Although these new Decrees are positive actions, it’s still too early to determine the long-term implications for the market,” Brisolla says. “We’ll continue to monitor the situation.”

Stewart Eisenhart


  • Stewart Eisenhart