Maintain safety and performance of medical devices throughout the supply chain
Maintaining and improving quality assurance throughout the distribution chain is a key priority for the Medical Device Authority of Malaysia. It requires all medical devices to be registered and all stakeholders, including manufacturers, importers, exporters, distributors and service providers to be licensed. As part of these requirements, quality management system such as ISO 13485 and Good Distribution Practices for Medical Device (GDPMD) need to be in place so as to ensure regulatory compliance are met.
GDPMD is applicable to all parties in the supply-chain except manufacturers and retailers of medical devices. GDPMD ensures stakeholders are vigilant in terms of safety and performance issues of medical devices and safeguards the health interests of the general public.
GDPMD responsibilities & scope of activities
GDPMD also aims to provide a clear legal framework which identifies responsibilities and accountability of all stakeholders throughout the supply chain. As part of the regulatory requirements, stakeholders need to have the appropriate procedures, personnel, processes, facilities, equipment and documentation in place.
The stakeholders' scope of activities to be certified include the following listed below;
- Storage & handling
- Secondary Assembly
- Distribution (Including transportation)
- Installation, testing & commissioning (Including the required facilities)
- Maintenance and calibration (Including the required facilities)
- Documentation (Including traceability of medical devices)
- Applicable sections of the Medical Device Act 2012 (Act 737) and its subsidiary legislations.