Brazil proposed resolution provides for the expiration date of the registration of medical devices

Brazilian Health Regulatory Agency (Anvisa) proposed Resolution provides for the expiration date of the registration of medical devices. The term of 10 years for the validity of the registration of medical devices is established. This Resolution applies to medical devices within the scope of "correlatos" referenced by Law No. 6,360, dated 23 September 1976. Medical devices include medical products and diagnostic products for in vitro use, as defined in Ministerial Order MS / MDIC No. 692, of 8 April 2009.

The validity periods of registrations granted prior to the publication of this Resolution are automatically extended to 10 years, counted from the last publication of registration or revalidation.

Products covered: Medical Devices

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: 06-10-2017

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.