Interested in learning more about the medical device registration process in Brazil? Emergo's Ann Marie Boullie, Vice President of Business Development, and Tatiana Sell, International Projects Manager, discuss some of our most frequently asked questions in this podcast interview.
Frequently Asked Questions
Class I and II applications are approved by ANVISA within seven months. Since Class III and IV device manufacturers must also submit a Brazil GMP certificate to ANVISA, the approval timeframe could be up to four years due to ANVISA’s backlog. These timelines exclude the timeframe for the preparation of your ANVISA registration technical file and associated document translations.
Can I transfer my registration to another company?
In most cases, ANVISA does not allow transfer of a registration. According to Brazilian Resolution RDC 22/2010, registrations can only be transferred under the following scenarios: merger, spinoff, incorporation or succession of the BRH. ANVISA will not allow a transfer of a registration if you want to switch distributors, for example.
Can we accelerate our B-GMP inspection?
In late 2012, some members of the Brazilian medical device association ABIMED filed a lawsuit against ANVISA. This lawsuit requested that ANVISA accept Quality System certifications granted by other international agencies (such as ISO 13485 certification) in situations where ANVISA has not been able to inspect foreign manufacturing sites within six months of the original inspection request.
The judge agreed and now those ABIMED members that were part of that lawsuit, including Emergo, can submit device registrations without the B-GMP certificate. Instead, the device application can be submitted showing proof that you have been waiting six months or longer for your GMP inspection, plus proof of other quality system certification. This saves valuable time and money, as ANVISA is currently backlogged by 3 to 5 years on GMP inspection requests.
Our device is subject to IEC 60601 series testing. Does this mean we need INMETRO certification?
Most likely, yes. Brazilian Normative Instruction (IN) 9/2013 outlines the standards for which INMETRO applies. If you do need INMETRO certification, your existing test reports can be used if they meet the following criteria: IEC 60601 3rd edition testing conducted through an International Laboratory Accreditation Cooperation (ILAC) member lab; your test reports are less than two years old; your testing was conducted to the standards listed in IN 9/2013. If you don’t have to retest, then you’ll simply need to contract with an INMETRO certifier, who will review your product file and conduct a pre-certification audit. These certificates are valid for 5 years and annual audits are required to maintain your certificate.