Malaysia conditional permission COVD19 self-test kits

Conditional permission for the import & distribution of Covid-19 self-test kits into Malaysia

To alleviate the burden on frontliners and to ease the detection and control of Covid-19 cases, the Health Ministry’s Medical Devices Authority (MDA) has granted conditional permission for the import and distribution of the Covid-19 self-test kits into the country. Circular letter No. 1/2021 dated 14 July 2021 was posted on the MDA website on 18 October 2021 and is effective from the date of its issuance.

Since the COVID-19 outbreak, the MDA has exempted COVID-19 test kits from registration requirements to assist medical staff in combating COVID-19 in Malaysia. These exempted kits are limited to professional use by staff in hospitals and health laboratories. Suppliers who wish to supply COVID-19 test kits are required to notify the MDA through special access notification.

Due to the high and rising positivity rate, the MDA has considered the use of Covid-19 self-test kits since they are useful in confirming positive cases. However, COVID-19 self-test kits cannot be granted through special access notification as the requirement states that COVID-19 test kits only can be operated by a medical practitioner. Therefore, the MDA has given Conditional Approval for the import and distribution of Covid-19 self-test kits for public use where the importation and distribution comply with the requirements together with the payment of certain fees (Application fee and Conditional Approval fee) as specified by the authority. Among the regulations imposed on self-test kit importers and distributors are to provide clear and user-friendly instructions for usage and disposal methods, the implementation of a test kit safety and performance monitoring system, and test kit distribution records.

Click here to read the full Circular No. 1/2021 issued by the MDA.

If you have any queries regarding the Conditional Approval of the importation or distribution of COVID-19 self-test kits or our services for medical device registration and representation in Malaysia, contact your Regulatory Affairs Specialist at Andaman Medical or contact us at sales@andamanmed.com or by clicking the button below.

To learn more about registering medical devices in Malaysia click here.

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