BRA/730
WTO/TBT
BR Brésil
  • 11 - Technologies de la santé
2017-10-06
2017-08-09
Medical Devices

Draft Technical Resolution n. 371, 1 August 2017. (3 page(s), in Portuguese)

This Draft 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.