Brazil is the largest economy in Latin America and the most promising medical device market. Medical device market in Brazil is governed by the Brazilian Health Regulatory Agency, ANVISA. The ANVISA came up with a new resolution, RDC 687/2022, for granting or renewing the Brazilian Good Manufacturing Practice (BGMP) certification for medical devices and is in effect from June 01, 2022, annulling RDC 183/2017.  

RDC 183 was published in 2017 to modernize and accelerate the process of issuing GMP certificates. The Resolution RDC no. 687 was published on May 13, 2022, to simplify the documentation required for GMP certification. It brings down the technical requirements for the certification giving great momentum to the certification process.

According to RDC 687/2022, the criteria for certification applies to manufacturers of Class III and Class IV medical devices, as follows:

• Manufacturing site that manufactures the finished product in its name or for another company
• Manufacturing site performing the final release of the final product, related to at least one production stage, debarring design, distribution, sterilization, packaging, and labeling.
• Manufacturing site of Software as a Medical Device (SaMD)

Essential Documents for BGMP Certification

The manufacturers must submit the following mandatory documents for the certification:–

• Completed application form for BGMP certification for medical devices
• General production flowchart for manufactured products, identifying which stages are performed at the manufacturing site undergoing the certification process
• The layout of the manufacturing site undergoing the certification process, including plant floor plans
• List of all products subjected to ANVISA, manufactured by the site undergoing certification process, contains technical name, production line (medical equipment, material, or devices for IVD), and risk class
• A statement notifying whether products that are or will be commercialized in Brazil are standardized in the country of origin and countries integrating MERCOSUR (South American trade bloc) and IMDRF (International Medical Device Regulatory Forum)
• List of inspections and Regulatory audits of the manufacturing site undergoing certification process for the last three (03) years
• Documents certifying compliance with GMP in the country of origin
• Copy of inspection report issued by the Health Authority of a member country of a specific audit program recognized by ANVISA, such as MDSAP (Medical Device Single Unit Program)

Another revolution brought to light by the ANVISA is the risk assessment tool published on the ANVISA website portal. The tool aims to make the process more structured and brings in transparency by facilitating clear visibility of the process for manufacturers. A maximum period of 180 days is established for seeking GMP certification for the new manufacturing site.

The changes introduced under the resolution are expected to ease the documentation required for the GMP certificate. It is a boon for foreign medical device manufacturers willing to register their products in the Brazilian Market.

If you are looking for an impact assessment on your device registrations or Regulatory services in Brazil and other LATAM countries, reach out to a regional Regulatory expert today!