Brazil | Extraordinarily and temporarily establishes the submission procedure for clinical studies required to validate medical devices of Classes III and IV

Title of document
Resolution – RDC number 375, 17 April 2020 (2 page(s), in Portuguese)

Description
This resolution extraordinarily and temporarily establishes the submission procedure for clinical studies required to validate medical devices of Classes III and IV identified as essential to healthcare services, due to the international public health emergency related to the SARS-CoV-2.

Notifying member: Brazil

Notification: G/TBT/N/BRA/1021

Objective tag
Protection of human health or safety

Documents

• RDC_375_2020_.pdf

Agency responsible
National Institute of Metrology, Quality and Technology (INMETRO) Telephone: +(55) 21 2145.3817 Email: barreirastecnicas@inmetro.gov.br Web-site: www.inmetro.gov.br/barreirastecnicas

Timing:

• Submission: 10/06/2020
• Reception: 11/06/2020
• Distribution: 11/06/2020
• Final date for comments: N/A
• Proposed date of adoption: N/A