GDPMD refers to Good Distribution Practice for Medical Devices. It specifies the requirements for a quality management system to be established, 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).

Why do you need to be certified with GDPMD?

• A license to trade in the logistics and shipping of medical devices
• Develop consistent product or service quality, efficiency and cost benefits

GDPMD requires an establishment to demonstrate its ability to maintain quality, safety, and performance of medical devices in compliance with the Malaysian medical device regulatory requirement throughout the supply-chain. It demonstrates that companies dealing with medical devices have an acceptable standard of quality distribution system in place.

In an effort to provide such assurance, medical devices importer and distributor are required to have the documented procedures and keeping records beyond the life of the medical devices for traceability purpose. Medical devices manufacturers who have certified to ISO 13485 will not need to apply for GDPMD and will find that they have partially fulfilled the GDPMD requirements.

ISO Specialist can help your organization:

• To provide assistance and guidance in the development of documentation.
• To monitor the system implementation to detect any system defect and identify areas that requiring improvement.
• To carry out related training to your company personnel in creating awareness and provide them with the basic necessary knowledge and skills in the implementation of the system.
• To provide necessary assistance with the preparation and submission of an application to Medical Devices Authority.
• To carry out Internal Audit in ensuring system readiness prior to Competent Authority Body's audit.
• To assist in close out of non-conformance raised by the Competent Authority Body until successfully certified