BRA/842
WTO/TBT
BR Brasilien
  • 11 - Medizintechnik
2018-11-12
2018-09-18

Medical devices

Draft Resolution 546, 3 September 2018 (12 page(s), in Portuguese)

This Draft Resolution 546/2018 lays down technical requirements for the manufacturing, marketing, import, export and exposure to use of custom-made and patient specific medical devices and medical devices exempt from registration.

This Draft Resolution does not apply to active medical device, in vitro diagnostic medical devices, medical devices under clinical investigation and services provided by dental prosthesis laboratories.

The requirements established in this Resolution address, among others: good manufacturing practices, labelling, traceability labels, technovigilance, product dossier, safety and efficacy requirements.

The adaptable medical device is regulated by Anvisa and must comply to the requirements established in the Collegiate Board Resolution - RDC nº 185, from 22 October 2001, Collegiate Board Resolution - RDC nº 40, from 26 August 2015 and other current specific regulations.

Custom-made and patient specific medical devices national manufacturing and import companies must keep documents to ensure traceability to the patient. Anvisa will not provide previous authorization for product manufacturing for custom-made and patient specific medical devices.