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MDA/GD/0014 May 2020 First EditionMEDICAL DEVICE GUIDANCE DOCUMENTMANDATORY PROBLEM REPORTINGMedical Device AuthorityMINISTRY OF HEALTH MALAYSIA/GD/0014ContentsPagePreface ................................................................................................................

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How to fill out notification of unregistered medical

01

Obtain the notification of unregistered medical form from the appropriate regulatory body.

02

Fill out the form with accurate and complete information about the medical product.

03

Include details such as the name and address of the manufacturer, product description, intended use, and any relevant certification or testing information.

04

Sign and date the form to certify its accuracy and completeness.

05

Submit the form to the regulatory body according to their specified submission process.

Who needs notification of unregistered medical?

01

Manufacturers or distributors of medical products that are not yet registered and require notification to the regulatory body.

02

Individuals responsible for ensuring compliance with regulations regarding unregistered medical products.

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What is notification of unregistered medical?

The notification of unregistered medical is a form that must be submitted to the appropriate regulatory agency to inform them about a medical product that has not been officially registered or approved for sale or use.

Who is required to file notification of unregistered medical?

Manufacturers, importers, distributors, or individuals who possess unregistered medical products are required to file the notification of unregistered medical.

How to fill out notification of unregistered medical?

The notification of unregistered medical form typically requires information about the product, its intended use, manufacturer details, and any known risks or side effects.

What is the purpose of notification of unregistered medical?

The purpose of the notification of unregistered medical is to ensure that regulatory agencies are aware of the existence of unregistered medical products and can take appropriate action to protect public health.

What information must be reported on notification of unregistered medical?

Information such as product name, manufacturer details, intended use, known risks or side effects, and quantities in possession must be reported on the notification of unregistered medical.

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