Announcement: Update in guidance document MDA/GD/0070 Establishment Guide To Medical Device Registration Submission In Medc@St Through Conformity Assessment By Way Of Verification Process (Second Edition)
The guidance document has been updated to improve clarity and consistency as below:
Summary of changes:
● Section 6 Pre-Market Clearance / Pre-Market Approval, Annex 1 Recognized Regulatory Authorities Or Notified Bodies:
- The description regarding evidence of approval for Singapore (HSA) and Thailand (FDA) has been rephrased.
● Annex 4 Submission Guide For Class B, C, And D For Conformity Assessment By Cab And Submission Of Application In Medc@St For New And Re-Registration Application.
- An editorial amendment has been made to include the table title Table 4: Types of Approvals Eligible for Conformity Assessment by Way of Verification Process.
These updates do not introduce new requirements but provide clearer interpretation of existing information.
For further information, please refer to the latest guidance document available at here : Medical Device Registration Submission In Medc@St Through Conformity Assessment By Way Of Verification Process (Second Edition)
Prepared by: Policy and Strategic Planning Division (DASAR)
Updated by: Corporate Communication Division
Date of publish: 13th October 2025
