Brazilian Regulators Set Date for More Flexible Medical Device Registration Transfer Rules
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 (link in Portuguese) 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
Transfer requirements for approved registrations
For transfers of device registrations already approved by ANVISA, the original BRH must submit a cancellation request, while the new BRH must submit a transfer request; the counterparties must also provide a declaration signed by their technical and legal managers as well as other administrative documents.
The original BRH must request a registration cancellation at the same time as the new BRH requests a transfer. ANVISA will then issue a new registration number to the new BRH. These two separate transactions must occur concurrently.
(Information on ANVISA’s medical device registration process in Brazil is available via our in-depth video.)
Transfer requirements for registrations pending approval
In cases where counterparties seek transfers of registrations that have been submitted to ANVISA but not yet approved, the original BRH must submit an amendment to its original application as well as documents required by RDC 102/2016, plus associated fees.
Questions regarding BGMP certificates
The issue of what happens to devices’ Brazil Good Manufacturing Practice (BGMP) quality system certifications once transfers are made between BRHs is a pertinent one—will certification transfer from the old BRH to the new BRH along with registration, or will the new registration holder need to obtain new BGMP certification for the device in question?
In cases where all devices manufactured at a BGMP-certified site are transferred to the new BRH, then it appears that the BGMP certificate for that site will remain valid for that new BRH. However, if only part of the site’s product line will be transferred, there is some open discussion about how to handle such situations, which Emergo will continue monitoring.