Q&A on Brazil’s Regulatory Changes for Devices

Marcelo do Ó, managing director and partner at L.E.K. Consulting, in São Paulo, Brazil, talked with FDAnews about recent changes by Brazil’s National Surveillance Agency.

FDAnews: ANVISA has extended the registration period for high-risk Class III and Class IV devices and in vitro diagnostics from five years to 10 years. What are the implications of this change?

Answer: According to ANVISA, 94 percent of device renewals are approved, and this control does not release the need for the initial approval, modification approval and technology vigilance processes. The extension from five years to 10 years for renewal should not be confused with lack of control procedures, since they continue in place. Note that a few countries, including Australia and the USA do not require renewals.

For classes III and IV, it is important to note that there is a reasonable level of rigor to approve the product in the first place. So as long as there is no material modification or negative techno vigilance data, the product safety should be secured from the moment the analysis was conducted for the initial registration.

Q: ANVISA has made a lot of changes geared toward streamlining operations. One of those was to ease restrictions on imports. Why is the agency making these changes?

A: There is an effort at ANVISA to reduce bureaucracy and streamline internal processes. They have been criticized for taking two years to approve a generic product or more than that for renewing products. Just as an example, an approved product, in perfect registration condition, could take two years or more to be transferred from one company to another (in the case of licensing for example) even without changing the manufacturing site. This resulted in a backlog that was becoming difficult to manage.

We should continue to see progress as ANVISA addresses the inefficiencies. ANVISA was considering at one point granting registration, or temporary registration, if a product was approved by a major recognized regulatory authority, such as the FDA or EMA.

Q: What will these recent changes mean for device manufacturers wanting to expand their market in Brazil?

A: Multinational companies typically welcome improvements that do not put patient safety at risk. We’ve seen some companies push for tougher regulation (biosimilars for example) to make the approval bar higher. But in general, this move will require less regulatory resources and encourage innovation.

ANVISA has been recognized as a high quality technical authority, but inefficient in terms of timelines, discouraging competition, innovation adoption and delaying patient access to new products. A move that generates higher efficiency without sacrificing good quality and safety for the public is welcomed by all.