On January 23 2018, ANVISA issued Resolution RDC 211 and RDC 212/2018, which deal with the validity period of medical device registry, as well as with the procedures related to the renewal of product registration.

According to the new legislation, the registries of medical devices and IVDs (risk classes III and IV) will have a validity extended of five to ten years, beginning from the day of its publication in Brazilian Official Gazette (DOU). The registrations may be renewed successively for the same period. It is important to note that the validity of current registries (approved prior to the publication of the new Resolution) will be automatically extended to ten years. The requests for registry renewal which were applied to ANVISA up to the date of publication of the new Resolution shall be closed by ANVISA.
According to ANVISA, the new RDC reflects the advance of the regulatory model for medical devices, which allows the extension of the validity period of the registries without compromising the health risk control, since all activities of inspection and monitoring of these products will be preserved inside the National market.

From the point of view of DOMO Salute, the new legislation brings benefits to manufacturers and importers, once the maintenance of the registries of medical devices becomes easier and less costly and consequently, makes Brazil more attractive for the entrance of these products.