Brazil | Enhancing Validity Period for Medical Device Good Practices Certificates: A Draft Resolution on Administrative Procedures

Title of document
Draft Resolution 1208, 16 October 2023

Description
This draft resolution?proposes changes to administrative procedures for granting Good Practices Certification Manufacturing and Certification of Good Distribution and/or Storage Practices, to enable the increase in the validity period of certificates of good manufacturing practices (CBPF) of medical device manufacturers granted through the Medical Device Single Audit Program - MDSAP.

Notifying member: Brazil

Notification: G/TBT/N/BRA/1506

Objective tag
Protection of human health or safety (TBT)

Documents

• 23_13055_00_x.pdf
• consulta+_publica_1208_2023+SGCOL+DP+.pdf
• index.php

Timing:

• Submission: N/A
• Reception: N/A
• Distribution: 19/10/2023
• Final date for comments: N/A
• Proposed date of adoption: N/A