Brazil’s National Health Surveillance Agency (ANVISA) published a new Resolution of the Collegiate Board of Directors (RDC) and a Normative Instruction (IN) with an issuance date of March 6. These regulatory documents will introduce new classification rules for petitions to change medical devices. ANVISA published a news article (link in Portuguese) on their website summarizing the changes and explaining how they differ from current regulations.
Three categories of medical device changes
RDC 340/2020 will classify medical device changes in three categories, according to the type of change requested and the level of risk to health posed by the device’s existing functionality. The categories are as follows:
- Modification with approval required: considered to be of greater health relevance. It will be authorized only after ANVISA analyzes the application and issues a favorable opinion.
- Modification for immediate implementation: considered to be of medium health relevance. It will be authorized as soon as the company submits the appropriate application to ANVISA. For changes in this category ANVISA will conduct periodic audits to ensure that changed devices remain in compliance.
- Non-reportable modification: considered to be of lesser health relevance. It can be implemented at any time by the company without the requirement to submit an application to ANVISA.
The government announcement also stated that all medical device changes must be conducted in compliance with Brazilian Good Manufacturing Practice (BGMP).
RDC 340/2020 and IN 61/2020 were approved on March 3 and will take effect on April 1. They were drawn up after a period of public consultation and based on input from several Brazilian associations of medical device manufacturers and importers.
Learn more about Brazilian medical device regulations at Emergo by UL:
- Brazil ANVISA medical device registration and approval consulting
- Brazil GMP (BGMP) quality management system compliance support
- ANVISA medical device vigilance reporting
- Whitepaper: Medical device registration in Brazil
- ANVISA medical device regulations resource page