On September 16,2020 Brazil’s Anvisa published RDC 423/2020 which deals with the reclassification of medical devices of Class II risk from registration pathway to the notification pathway. The Resolution enters into force on the date of its publication September 16,2020.
Prior to this change in regulation, only products of risk class I (low health risk) were allowed to be under the Notification Pathway. Anvisa reaffirms industry concerns that the changes in the regulations will not impact the manufacturing sector, since the operational adjustments necessary for Anvisa concern only the adequacy of the risk classification approved by RDC nº 416/2020 and include the denomination of petitioning subjects and adequacy of technical-administrative flows.
Anivsa believes the new distribution of sanitary risk classes of products will allow greater balance and agility in the analysis of products with higher risk, as well as reduce the time needed for market authorization for products with lower risk classification to reach the Brazilian population.
The pathway of notification starts to be applied to the products of low and medium-low sanitary risks (classes I and II); and the pathway of registration to the products of medium-high and high sanitary risks (classes III and IV).
Product Sanitary Risk Class
Classes I and II
(Medical devices of low and medium-low sanitary risks)
Classes III and IV
(Medical devices of medium-high and high sanitary risks)
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. To learn more, please contact us at firstname.lastname@example.org