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MDA/GD/0053 January 2020 First EditionMEDICAL DEVICE GUIDANCE DOCUMENTNOTIFICATION FOR ORPHANED MEDICAL DEVICEMedical Device Authority MINISTRY OF HEALTH MALAYSIAMDA/GD/0053ContentsPagePreface ...................................................................................................................iii1Introduction
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01
Step 1: Obtain the application form from the Malaysia MDA website or office.
02
Step 2: Fill in the required personal and product details accurately.
03
Step 3: Gather all necessary supporting documents such as product specifications, certificates, and labels.
04
Step 4: Submit the completed application form and all documents to the MDA either online or in person.
05
Step 5: Pay any applicable fees associated with the application process.
06
Step 6: Wait for the MDA to review your application and provide feedback or request further information.
07
Step 7: Receive the final decision and any certification or registration documents if approved.

Who needs malaysia mda has issued?

01
Manufacturers of medical devices seeking to sell their products in Malaysia.
02
Importers of medical devices who need to ensure compliance with local regulations.
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Distributors looking to operate in the Malaysian market with legal medical devices.
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Healthcare providers that require approval for the medical devices they intend to use.
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The Malaysia MDA (Malaysian Digital Authority) has issued guidelines and regulations pertaining to digital and online activities to ensure compliance with national standards and promote digital transformation.
All businesses and individuals engaged in digital activities or utilizing digital platforms in Malaysia are required to file according to the MDA's regulations.
To fill out the Malaysia MDA form, individuals and businesses must provide necessary details regarding their digital operations, revenue, and compliance measures, following the guidelines specified in the MDA issuance.
The purpose of the Malaysia MDA issuance is to ensure that digital businesses adhere to national regulations, enhance accountability, promote data security, and support the growth of the digital economy.
Reported information typically includes business details, digital platform usage, revenue generated, compliance with laws, and any relevant operational data required by the MDA.
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