News

Institutional

3 de August de 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

Last related news

12 de June de 2025

Kasznar Leonardos is ranked on Leaders League 2025

We are pleased to announce that, once again, we have been ranked by Leaders League Brazil, a respected publication in the legal field. Kasznar Leonardos is ranked on Leaders League 2025

  • Kasznar Leonardos
  • Ler notícia

    12 de June de 2025

    Kasznar Leonardos was ranked on WTR Global Leaders 2025

    We are proud to announce that two of our partners have been included in the WTR Global Leaders 2025! Gabriel Leonardos and Kasznar Leonardos was ranked on WTR Global Leaders 2025

  • Kasznar Leonardos
  • Ler notícia

    7 de June de 2025

    Kasznar Leonardos was ranked on IP Stars 2025

    We are proud to announce that we have been ranked in the 2025 edition of IP STARS, conducted by Managing IP. As Kasznar Leonardos was ranked on IP Stars 2025

  • Kasznar Leonardos
  • Ler notícia
    plugins premium WordPress