In July 2013, Malaysia’s Medical Device Authority (MDA) issued its latest guidance on good distribution practices (GDP) for medical devices sold in Malaysia. This is an update of previous standards, which were released in draft form in November 2010.
The new guidance describes standards for medical device procurement, transportation, delivery, storage, installation, calibration, after sales service, tracking and other medical device supply-chain activities. The guidance applies to importers, distributors and authorized representatives of foreign device makers, but it does not apply to medical device manufacturers and retailers.
In addition, the new guidance outlines GDPMD certification procedures. Certification should be carried out by one of Malaysia’s registered conformity assessment bodies (CAB). Certification materials should include information on special storage and handling conditions, outsourced activities, and the scope of activities performed by the establishment itself, such as:
- Import procedures
- Storage and handling
- Warehousing
- Secondary assembly
- Distribution (including transportation)
- Installation, testing and commissioning
- Maintenance and calibration
- Documentation (including tracking of medical devices)
Tracking is mandatory to the patient level for the following high-risk implantable devices: mechanical heart valves, pacemakers, defibrillators, ventricular support systems and drug infusion systems. Other medical devices must have a traceability system in place, but companies do not need to maintain the same patient level tracking records.