ANVISA has published, on 08/02/2017, in the Federal Register, the the Public Consultation 371/2017 to discuss the extension, from 5 to 10 years, of medical devices registration term. The measure aims to align ANVISA’s regulation with the provision on Article 12, Paragraph 1th, of Law 6,360/1976, included by Law 13,097/2015.
The Director responsible for the proposal, Mr. Renato Porto, justified it on the absence of risk, considering the already rigorous criteria for registration of Classes 3 and 4 medical devices. Furthermore, he highlighted the scarce denials concerning requests of renewals of such products. According to the Director, by and large, in renewal cases the technical area analysis is merely administrative. Last but not least, the proposal allows medical devices already registered to automatically have an extended term. In other words, the extension is not intended only for products registered after the publication of the new rule.
Access all the issues discussed by the Board of Directors’ Meeting 19/2017 clicking here.
The Public Consultation will be open for 60 days, starting from 08/09/2017. For further clarifications, do not hesitate to contact us through e-mail email@example.com