Distribution is an important activity in the integrated supply-chain of medical device. Various people and entities are generally responsible for the product sourcing, procurement, transportation, delivery, storage, device tracking, installation, commissioning, service and maintenance, calibration, need to be appropriately managed and controlled to ensure the safety and performance of medical devices at the point of use. In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. The level of risks associated with these activities may be of similar degree as those in the manufacturing environment and the lack of control over these activities may affect safety and performance of the devices. The Good Distribution Practice for Medical Devices (GDPMD) is developed to elucidate the requirements for an appropriate management and control of these activities. GDPMD 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). 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 shall be used by both the internal and external parties to determine the ability of an establishment to meet the requirements specified within.
The certification to GDPMD is to be conducted by the registered conformity assessment body. The design and implementation of GDPMD by an establishment is dependent on the types and categories and classification of medical device, size and structure of the establishment, the processes employed it deals with. It is not the intent of the GDPMD to imply uniformity in the structure of the quality management systems or uniformity of documentation. Certification to GDPMD does not imply compliance to any written laws. It is the responsibility of the establishment to ensure that they are in compliance with all applicable laws in Malaysia. In the event of any contradiction between the requirements of GDPMD and any written law, the latter shall take precedence.
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