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MDA/GD/0055 16 April 2020 First EditionMEDICAL DEVICE GUIDANCE DOCUMENTNOTIFICATION FOR OBSOLETE AND DISCONTINUED MEDICAL DEVICEMedical Device Authority MINISTRY OF HEALTH MALAYSIA/GD/0055ContentsPagePreface
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How to fill out malaysias medical device authority
How to fill out malaysias medical device authority
01
Prepare all necessary documents required for registration such as product information, manufacturing details, and intended use.
02
Complete the application form with accurate information and attach all supporting documents.
03
Submit the application form along with the required fees to the Malaysia Medical Device Authority (MDA).
04
Await for the evaluation and approval process by the MDA.
05
Once approved, the medical device authority certificate will be issued.
Who needs malaysias medical device authority?
01
Manufacturers and importers of medical devices in Malaysia.
02
Healthcare facilities that utilize medical devices.
03
Distributors of medical devices in Malaysia.
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What is malaysias medical device authority?
Malaysia's medical device authority is known as the Medical Device Authority (MDA).
Who is required to file malaysias medical device authority?
Manufacturers, importers, and distributors of medical devices are required to file with Malaysia's Medical Device Authority.
How to fill out malaysias medical device authority?
To fill out Malaysia's medical device authority, one must provide information about the medical device such as its classification, intended use, and a description of the device.
What is the purpose of malaysias medical device authority?
The purpose of Malaysia's medical device authority is to regulate the manufacturing, importation, and distribution of medical devices to ensure their safety and quality.
What information must be reported on malaysias medical device authority?
Information such as the classification of the medical device, its intended use, the name and address of the manufacturer, importer, and distributor, and details of the authorized representative must be reported on Malaysia's medical device authority.
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