Overview:
Anvisa’s Collegiate Board approves a new regulatory mark that will allow the economic monitoring of medical devices commercialized in Brazil.
The Collegiate Board of ANVISA (Dicol) approved in a regular public meeting held on March 11, 2021 the Resolution – RDC that provides for the economic monitoring of medical devices.
Regulation for Price Monitoring of Medical Devices:
The goal of the new regulatory mark is to contribute to the relative price reduction of medical devices in Brazil. The measure is expected to facilitate the definition of reference prices for public or private procurement of medical devices. In addition, the implementation of monitoring is expected to contribute to transparency and to reduce information asymmetry in this market, through the dissemination of historical price statistics.
In this meeting, two Normative Instructions (IN) were approved, which provide the list of medical devices selected for economic monitoring by Anvisa and the technical attributes of these devices.
With the publication of the new Normative Instructions, RDC 185/2006 and Resolution – RE 3385/2006 will be revoked.
The results of the economic monitoring will be disclosed in Anvisa’s electronic portal, by means of a tool that will allow the consultation of historical statistics of prices charged by grouping of medical devices with similar technical characteristics, according to the technical attributes informed for each model.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.