The Brazilian National Health Supervision Agency (Agência Nacional de Vigilância Sanitária, ANVISA) is responsible for the registration of medical devices in Brazil. The main regulations including RDC 751/2022, etc. Manufacturers outside Brazil need to have a local authorized representative in Brazil to hold the license.

Brazil classifies medical devices into Class I, II, III and IV according to risk levels from low to high. Manufacturers of products of all risk levels need to meet the requirements of Brazilian Good Manufacturing Practice (BGMP).

Registration of lower-risk Class I and Class II medical devices does not require BGMP certification, as long as the manufacturer has a quality management system that meets BGMP requirements. Even though ANVISA will not review technical documents, they need to be kept by the Brazilian authorized representative in case of ANVISA inspection.

Higher-risk Class III and Class IV medical devices must first obtain BGMP certification before submitting technical documents to ANVISA for review. It should be noted that although Brazil participates in the medical device single audit program (MDSAP), it will only accelerate the certification’s procedure but cannot replace BGMP certification.

The Brazilian authorities’ requirements for technical documentation are stated in the RDC 751/2022 regulation. In order to be in line with international standards, documents other than labels and instructions can be submitted in Portuguese, Spanish or English.

The registration fee for low-risk Class I and Class II products is about US$500 and takes about one month. The registration fee for high-risk Class III and Class IV products is about US$1,500, and a BGMP audit costs about US$25,000. The registration time including the BGMP audit is about 1.5 to 2 years.

The registration for Class I and II products will not expire, while the registration for Class III and IV products is valid for ten years. The BGMP certificate is valid for two years and will be audited every two years by ANVISA or its recognized third-party organization. The registration certificate can be transferred to the new authorized representative, but this process requires the cooperation of the previous authorized representative to proceed smoothly.

Osmunda’s global team can assist you in completing product registration in Brazil and provide you with local agency services in Brazil. If you want to know more about the registration of your product in Brazil, please feel free to contact us.