Distribution is an important activity in the integrated supply-chain of medical device.
Various people and entities are generally responsible for various activities within this supply-chain. These include product sourcing, procurement, transportation, delivery, storage, device tracking, installation, commissioning, service and maintenance, calibration, which need to be appropriately managed and controlled to ensure the safety and performance of medical devices at the point of use.
However, a person or entity may only be 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).
Principle of Good Manufacturing Practice (GMP)
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 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.