Good Distribution Practice for Medical Devices (GDPMD) is by ensuring the quality, safety and performance of medical device during all aspects of medical device supply-chain, which include, but not limited to, product sourcing and procurement; transportation and delivery; storage; installation, commissioning, service and maintenance, calibration and after sales service; tracking, documentation and record-keeping practices.
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. If any requirement in GDPMD is not applicable due to the type, category and classification of the medical device and supply-chain activities, a justification has to be provided for exclusion from fulfillment of that particular requirement.
If any requirement in GDPMD is not applicable due to the nature and the range of the medical device and supply-chain activities, a justification has to be provided for exclusion from fulfillment of that particular requirement.”
When assessed by AQCTA, GDPMD requires the following to be met:
Part 1 : Preliminary
Part 2 : Organization and GDPMD Regulatory Compliance System
Part 3 : Establishment Responsibilities
Part 4 : Resource Management
Part 5 : Supply Chain and Device Specific
Part 6 : Surveillance and Vigilance
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