Brazilian regulators set date for more flexible medical device registration transfer rules
By Stewart Eisenhart, Emergo Group
Brazil’s medical device market regulator ANVISA will implement new rules for more efficient transfers of device registrations between Brazilian Registration Holders (BRH).
After Emergo first reported on ANVISA’s transfer rule change plans in July 2016, the regulator has now issued RDC 102/2016 that introduces official regulation on those changes, set for implementation on December 25, 2016.
“With these new rules, it will be possible to transfer a device registration in Brazil without the need to have a corporate relationship,” explains Luiz Levy, Director of QA/RA at Emergo’s office in Brasilia. Existing regulations allow such transfers only in limited cases such as mergers and acquisitions.
Key features of the new transfer rules
RDC 102/2016 lays out several top-level requirements to which BRHs must adhere for proper transfers of registrations:
- The original registration holder must give contractual permission for transfer to the new holder
- Transfers must be submitted for ANVISA approval within 180 days of agreement signings
- Transfers do not require the consent of the device’s legal manufacturer—a distributor acting as a BRH could sell a registration to another distributor or BRH without notifying the device’s manufacturer
- Transfers may be requested for devices already registered with ANVISA as well as for devices that have been submitted but not yet approved for registration
- Transfers go into effect 90 days after publication in the Official Diary in order to ensure issues such as labeling and stock depletions are addressed
