EMERGO SUMMARY OF KEY POINTS:

• ANVISA has clarified its ownership transfer rules for corporate operations such as mergers and incorporations of companies registered to sell medical devices in Brazil.
• Qualifying Brazil registrants may concurrently submit both ownership transfer and registration cancellation requests to ANVISA.

ANVISA, Brazil’s medical device market regulator, has updated its recently issued ownership transfer regulation to clarify “corporate operation” issues.

The regulator’s RDC 118.2016 (link in Portuguese) adds one article, Article 44a, to RDC 102.2016, that defines “corporate operation” as a “corporate action involving the division, merger or incorporation under Law no. 10,406 of January 10, 2002 and, in a subsidiary manner, Law no. 6,404 of December 15, 1976.” (Emergo first analyzed the new ANVISA ownership transfer regulations in August 2016.)

The new article states that companies that have formalized any such corporate operations between July 12, 2016 and August 25, 2016 may submit requests to ANVISA for both ownership transfers and cancellations of product registrations at the same time. This should help ease the ownership transfer process for Brazil market registrants whose corporate operations occurred within the specified time period.

This allowance will remain in force until February 21, 2017.