Practice for Medical
Regulatory requirements for medical device safety & performance. It shall be implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian Medical Device regulatory requirements as stipulated in Medical Device Act 2012 (Act 737).
- Helps organizations in saving cost from reduction of defects and rejects.
- Meet regulatory requirements and customer expectations.
- Consistency to proper storage, handling, distribution and traceability.
- Demonstrate ability to produce safer and more effective medical devices distribution.