GDPMD: Good Distribution Practice For Medical Devices

A crucial component of the integrated supply chain for medical devices is distribution. To assure the performance and safety of medical devices at the point of use, a variety of people and entities are generally in charge of the transportation, storage, installation, product sourcing, procurement, delivery, device tracking, commissioning, servicing, and maintenance. Although, there are cases where an individual or organisation is only accountable for and active in a small portion of the distribution process. The dangers involved with these activities could be on the level with others in the manufacturing environment, and the lack of control over them could impact the devices' performance and safety. The Good Distribution Practice for Medical Devices (GDPMD) was developed to clarify the requirements for adequate administration and management of these operations.

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To comply with Malaysian medical device regulatory requirements as outlined in the Medical Device Act 2012 (Act 737), GDPMD details the requirements for a quality management system to be established, implemented, and maintained by an establishment when carrying out activities in the medical device supply chain.

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According to the Medical Devices Act of 2012 (Act 737), all businesses engaged in activities are subject to the Good Distribution Practice for Medical Devices (GDPMD). The medical device supply chain companies must create, implement, and keep up a quality management system.

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The accreditation confirms a facility's capability to maintain the performance, safety, and quality of medical equipment under its care. Representatives of international medical device producers, importers, and distributors in Malaysia are included in the standard.

GDPMD applies to the organization that wishes to trade and supply medical devices in Malaysia.

Medical devices are appropriately managed and controlled throughout the supply chain. Thus, ensuring their safety and performance at the point of use.

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Assures stakeholders through certification that the organisation can maintain quality, safety and performance of medical devices while under its custody.

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Fulfilment of establishment licensing requirements.

• The supply chain for medical devices is adequately managed and regulated. Consequently, their performance and safety at the point of use are guaranteed.
• Reassures stakeholders that the business can maintain the quality, safety, and performance of medical equipment in its care through certification.
• Adherence with licencing regulations for businesses.

Certification to GDPMD is a prerequisite as mentioned in Medical Device Act 2012 (Act 737).

With a clear understanding and the proper preparation of what is required for the GDPMD requirement and MDA regulations, most organizations can expect certification within 3 to 6 months, depending on the medical device (category) they supply.

The cost of consultation and certification varies depending on your certification scope, the complexity of the process and company/organization size. There is an additional cost where organization shall register their medical device with Medical Device Authority. The charges are from the authority.