WTO/TBT Notifications on Medical Technology

Ordinance No. 176, 19 April 2021, which approves the consolidation of metrological regulation establishing the general guidelines and requirements for the model evaluation process.

Ordinance: 84 – Approves the conformity assessment requirements for sterile hypodemic needles and sterile gingival needles for single use.

Ordinance 84, 10 February 2021, that approves the consolidation of conformity assessment requirements for sterile hypodemic needles and sterile gingival needles for single use and revokes the Inmetro Ordinance 501, 29 December 2011.

Public Consultation No. 1043 - Proposal to establish technical requirements for the import, commercialization, and donation of used reprocessed medical devices.

Public Consultation No. 1041 - Proposal to establish technical criteria for the concession or renewal of Good Manufacturing Practice Certificate for producers of medical devices.

Public Consultation No. 1042 - Proposal to establish technical requirements for the classification of orthopaedic implantable materials for the purpose of market authorization.

Resolution number 483, 19 March 2021 which establishes exceptional and temporary technical requirements for the import of new medical devices and medicines identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was amended by Resolution – RDC number 516, 2 June 2021.