Mar 26, 2021
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.
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:
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.)
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.
Ordinance No. 384/2020 allows for alternatives to on-site inspections, removes issuance data requirements for test reports, and makes INMETRO certificates valid indefinitely as long as maintenance audits are performed.
The Brazilian regulator expanded the range of products not subject to regulation by the GGTPS and released a guide that mirrors IMDRF guidance.