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10 questions
GDPMD is aimed to demonstrate organization's ability to maintain quality and innovation of medical devices in compliance with the Malaysian medical device regulatory requirement.
True
False
The GDPMD certification is to be conducted by the non- registered conformity assessment body (CAB).
True
False
Quality is defined as meeting customer and regulatory requirement and the device is safe and performs as per its intended purpose.
True
False
GDPMD guideline by Medical Device Authority (MDA MOH) is published to meet regulatory requirement as per Appendix 4 Schedule 3 of Medical Device Regulation 2012.
True
False
Detailed description on how the relevant and applicable regulatory requirements are addressed for each medical device specified in the scope of the GDPMD regulatory compliance system must be documented in the Laboratory Compliance Manual.
True
False
For each type of medical device, the establishment shall establish and maintain a file containing only raw materials specifications and with complete customer complaint records.
True
False
If the product lifetime is 18 months then the records retention period must be for a minimum of two years.
True
False
The management shall review its GDPMD regulatory compliance system at planned intervals, to ensure its compliance to Malaysian medical device regulatory requirements through management review process.
True
False
The Pest control program must include an SOP, Contract Agreement with Pest Control Service provider and periodical spot checks or audits.
True
False
For storage and stock handling, the organization must maintain an updated distribution records of medical devices it deals with including the make, model, batch number, serial number, and quantity of the devices.
True
False
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