The Medical Device Authority (MDA) of Malaysia requires all the organizations involved in the supply chain of medical devices to have a Good Distribution Practice for Medical Devices (GDPMD) certification in place. The main objective of this certification is to ensure proper management and monitoring of end-to-end supply chain of medical devices. The supply chain stakeholders must establish, implement and maintain a Quality Management System (QMS) to ensure that the safety and performance of the device is unaltered till it reaches the end user or Point of Care (PoC).
Where is the Requirement of GDPMD Defined?
The requirement of GDPMD, Malaysia is defined under the Appendix 4 schedule 3 Medical Device Regulation 2012. The Certification must be obtained from the Conformity Assessment Body (CAB).
Who Should Apply and Obtain a GDPMD Certificate?
All stakeholders of the supply chain except manufacturers and retailers shall obtain GDPMD certificate, duly issued by a Conformity Assessment Body (CAB), after a thorough inspection. The GDPMD certificate is an equivalent to ISO 13485:2016 certification for medical device manufacturers.
The organizations involved in below activities shall obtain GDPMD license for their establishments:
- 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)
The organizations applying for GDPMD certification shall be registered with the Suruhanjaya Syarikat Malaysia (SSM) before applying for GDPMD certification, Malaysia.
Why Should an Organization Implement GDPMD and Obtain a Certification?
The supply chain organizations shall implement the systems for listed reasons:
- It is a mandatory pre-requisite for obtaining establishment license from the Medical Device Authority (MDA), Malaysia
- It is a prerequisite for the logistics and shipping of medical devices
- It helps the organization deliver consistent product or service quality with maximum efficiency
- The Regulatory costs incurred due to manufacturing and distribution of defective devices can be avoided
What are Different Components for GDPMD Compliance?
The Regulatory requirements for medical device safety and performance under the GDPMD can be grouped into 5 categories -
- Organization and GDPMD Regulatory Compliance System
- Establishment Responsibilities
- Resource Management
- Supply Chain and Device-specific
- Surveillance and Vigilance
Medical device manufacturers willing to access the Malaysian market must be aware of the GDPMD certification process. For any further queries on implementation of GDPMD for your medical device or GDPMD consultation in Malaysia, seek a Regulatory expert’s assistance.