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MDA/GD/0011 JUNE First2020 EditionMEDICAL DEVICE GUIDANCE DOCUMENTCOMPLAINT HANDLINGMDA/GD/0011Medical Device AuthorityMINISTRY OF HEALTH MALAYSIAContentsPagePreface ..................................................................................................................
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What is medical device guidance document?
A medical device guidance document is a regulatory framework that provides information and instructions on how to comply with laws concerning medical devices, including safety, efficacy, and quality standards.
Who is required to file medical device guidance document?
Manufacturers and importers of medical devices are required to file the medical device guidance document to ensure compliance with regulatory requirements.
How to fill out medical device guidance document?
To fill out a medical device guidance document, gather relevant information about the device, including its specifications, intended use, manufacturing processes, and clinical data, then follow the guidelines provided by the regulatory authority to complete the necessary forms.
What is the purpose of medical device guidance document?
The purpose of the medical device guidance document is to provide clear instructions and regulatory expectations to ensure the safety and effectiveness of medical devices in the market.
What information must be reported on medical device guidance document?
Information that must be reported includes device description, manufacturing processes, quality control measures, clinical trial data, and compliance with relevant standards.
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