Institutional
August 3, 2017
Medical Devices – ANVISA´s Public Consultation to extend the registration term
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 bio@kasznarleonardos.com
Back
Share:
Last related news
July 24, 2024
Kasznar Leonardos will attend the 44th ABPI Congress
The 44th International Congress on Intellectual Property, promoted by the Brazilian Intellectual Property Association (ABPI) is coming, and Kasznar Leonardos’ presence is guaranteed! … Kasznar Leonardos will attend the 44th ABPI Congress
July 17, 2024
Kasznar Leonardos obtains special recognition from Leaders League Brasil
We are pleased to announce that we have been highlighted in the 2024 Leaders League Brasil Patent Litigation rankings research! We received … Kasznar Leonardos obtains special recognition from Leaders League Brasil
July 15, 2024
Partner Tatiana Silveira participates in ABAPI’s advanced patent course
Our partner Tatiana Silveira has been invited to teach in the advanced patent course organized by ABAPI (Brazilian Association of Industrial Property … Partner Tatiana Silveira participates in ABAPI’s advanced patent course