Brazilian Regulators Update Economic Monitoring Requirements for Some Medical Devices

Brazilian medical device regulator ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference pricing for these products.

The new regulation, RDC 478/2021 (link in Portuguese), repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. The new regulation is slated to take effect April 1, 2021.

Device types requiring economic monitoring in Brazil

In a new Normative Instruction (link in Portuguese), ANVISA identifies 13 device types falling under RDC 478/2021, including implantable defibrillators, cardiac valve prostheses, arterial stents and pacemakers. Data pertaining to price and technical specifications of these devices must be provided to ANVISA according to the following timeframes:

• For new registrations, submissions are required within 60 days of registration publication by ANVISA.
• For existing registrations, submissions are required either upon renewal of those registrations or 60 days following ANVISA approval of a device modification, whichever comes first.

Device-specific Normative Instructions to follow from ANVISA

Although ANVISA has set an April 1 deadline for implementation of RDC 478/2021, Emergo consultants in Brazil anticipate additional Normative Instructions from the regulator to address economic monitoring requirements for specific device types. (One such Normative Instruction for coronary stents has already been issued.)

Greater transparency and price management in Brazil’s medical device market

According to Emergo sources in Brasilia, the revised economic monitoring regulations reflect ANVISA’s ongoing efforts to more effectively set and maintain consistent pricing of medical devices for public and private healthcare purchasing and procurement entities. At the same time, RDC 478/2021 will require disclosure of technical attributes to facilitate more effective grouping of healthcare products sharing similar characteristics.

ANVISA plans to publish results of these economic monitoring initiatives on its electronic portal.

Additional Brazilian medical device regulatory resources from Emergo by UL:

• Brazil ANVISA medical device registration and approval consulting
• Brazil Registration Holder (BRH) in-country representation
• Whitepaper: Medical device registration in Brazil