The Post Market Division performs two main functions: monitoring the safety and performance of medical devices through post-market responsibilities and obligations carried out by establishments in accordance with the provisions of Act 737, Sections 37 to 42, and the Medical Device (Establishment Duties and Obligations) Regulations 2019; and monitoring compliance with the legal requirements outlined under Act 737 and its subsidiary regulations.

Among the activities conducted by this division for monitoring the safety and performance of medical devices are:


i. Managing complaints received from users involving safety and performance issues, including conducting investigations and issuing related directives;
ii. Monitoring and evaluating mandatory problem reports;
iii. Monitoring and evaluating reports on corrective actions in the field;
iv. Monitoring and evaluating recall reports;
v. Conducting compliance testing of medical devices already in the market.

Meanwhile, activities carried out to monitor compliance with the legal requirements outlined under Act 737 and its subsidiary regulations include:


i. Monitoring establishments;
ii. Market surveillance at retail premises, including pharmacies;
iii. Monitoring online advertisements of medical devices;
iv. Control of medical devices at entry points.

 

 

Prepared by: Post Market Division

Uploaded by: Corporate Communication Division

Date of upload: 12/11/2025