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MDA/GD/0013 JUNE 2020 First EditionMEDICAL DEVICE GUIDANCE DOCUMENTFIELD CORRECTIVE ACTION (FCA)Medical Device AuthorityMINISTRY OF HEALTH MALAYSIAMDA/GD/0013ContentsPagePreface ...........................................................................................................................

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Who needs mda guidance on field?

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What is mda guidance on field?

MDA guidance on field refers to the guidelines and procedures established by the Medical Device Authority (MDA) regarding the handling, registration, and reporting of medical devices in a specific field.

Who is required to file mda guidance on field?

Manufacturers, importers, and distributors of medical devices are required to file MDA guidance on field to ensure compliance with regulations.

How to fill out mda guidance on field?

To fill out MDA guidance on field, stakeholders must complete the prescribed forms accurately, provide necessary documentation, and submit them through the designated channels as outlined by the MDA.

What is the purpose of mda guidance on field?

The purpose of MDA guidance on field is to ensure the safety, efficacy, and quality of medical devices, as well as to facilitate regulatory compliance and oversight.

What information must be reported on mda guidance on field?

Information that must be reported includes details about the medical device, including its classification, intended use, manufacturing details, adverse events, and any changes to the device.

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