New Regulation in Brazil Changes Enforcement of BGMP Requirements for Certain Medical Devices

The Brazilian government has implemented a new regulation, RDC 15/2014 (link in Portuguese), that significantly eases the registration process for certain low-risk medical devices and IVDs.

Class I and II devices: BGMP no longer required

For Class I and II lower-risk devices registered with ANVISA and included on the regulator’s IN 2/2011 exception list, as well as for Class II in vitro diagnostic (IVD) devices, Brazilian Good Manufacturing Practice (BGMP) certification and fee requirements have been removed. Previously, devices included in IN 2/2011— such as sterilization and disinfection equipment, blood component processing equipment, resonance imaging equipment, gels, creams and liquids that come into contact with the body, contact lenses, and software that edits medical images—required BGMP certification in order to obtain ANVISA approval. Now, IN 2/2011 devices must still go through the full “registro” application process, but without the BGMP certification requisite.

Class III and IV devices: Less (if any) immediate benefit

Class III and IV devices are also covered in RDC 15/2014. For these devices, registrants may submit market authorization applications while still waiting for BGMP certification instead of having to hold off until they obtain final certification. Now, applicants can submit receipts proving BGMP inspection requests along with their registration application to ANVISA.

Will this new allowance result in faster registration times for Class III and IV devices? Probably not by much; ANVISA currently takes about four years to analyze BGMP requests, and even under the new law the regulator will not provide approval decisions until final BGMP certifications have been issued.

ABIMED route still the better registration option

According to Emergo Group's office in Brasilia, overall registration timeframes using ABIMED will be much more time and cost effective compared with other options, including suing ANVISA to expedite BGMP certification and product registrations. The ABIMED option is available only to Brazil Registration Holders who are members of the Brazilian association ABIMED, and possess an internationally recognized quality system certificate, such as the ISO 13485 certificate.

Stewart Eisenhart

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