News

MALAYSIA: MDA ANNOUNCED MANDATORY PROBLEM REPORTING REQUIREMENTS UNDER ACT 737 AND RULE 2019 − OCTOBER/NOVEMBER 2023

MALAYSIA: MDA ANNOUNCED MANDATORY PROBLEM REPORTING REQUIREMENTS UNDER ACT 737 AND RULE 2019 − OCTOBER/NOVEMBER 2023

  • 2023-10-20 06:51:30

The Medical Device Authority (MDA) announced on 19th September that any event involving registered medical devices that occurs outside of the country is not required to be reported to MDA if the incident has been notified to the regulatory agency in the country where the incident happened and corrective action or precautions have been taken by the manufacturer or establishment.

More