According to MDA, any incident involving registered medical devices that occurs abroad is not required to be reported to MDA if it has been reported to the regulatory agency in the country where the incident occurred and corrective action or precautions have been taken by the manufacturer or establishment, according to Rule 5(7) of the Regulations Medical Devices (Duties & Obligations of Establishments) 2019.

In accordance with Act 737 and the Medical Devices (Establishment Duties & Obligations) 2019 regulations, establishments must also regularly inspect the security and performance of their medical devices.

 

 

References:
Mandatory Problem Reporting Requirements Under Act 737 and Rule 2019