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MDA/GD/0024 May 2017 First EditionMEDICAL DEVICE GUIDANCE DOCUMENTREQUIREMENTS FOR EXPORT PERMITMedical Device Authority MINISTRY OF HEALTH MALAYSIA/GD/0024ContentsPagePreface ............................................................................................................
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What is medical device guidance document?
A medical device guidance document is a regulatory document that provides manufacturers, healthcare professionals, and other stakeholders with information on the standards, practices, and regulatory expectations for the development, testing, approval, and post-market surveillance of medical devices.
Who is required to file medical device guidance document?
Manufacturers of medical devices and parties involved in the development or marketing of medical devices are typically required to file medical device guidance documents.
How to fill out medical device guidance document?
To fill out a medical device guidance document, manufacturers should gather the necessary information, including device specifications, intended use, safety and efficacy data, and compliance with regulatory requirements, and present it in the specified format outlined by the regulatory authority.
What is the purpose of medical device guidance document?
The purpose of a medical device guidance document is to ensure the safety and effectiveness of medical devices, facilitate regulatory reviews, and provide clear expectations for compliance with applicable regulations.
What information must be reported on medical device guidance document?
Information that must be reported includes device identification details, manufacturer information, clinical data, risk assessments, and compliance status with relevant regulatory standards.
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