announcement on the requirements for covid 19 self test kits

MALAYSIA ANNOUNCEMENT ON THE REQUIREMENTS FOR COVID-19 SELF-TEST KITS

The Medical Device Authority (MDA) decided on 29 March 2022  to replace the requirement of lot-to-lot variation tests. Instead, it’s instituting the approval of a new lot of COVID-19 test kits with the requirement under the post market duties and obligations of the establishment. With this arrangement, the establishment shall inform MDA of any new lot of the test kits that will be placed in the market. The establishment shall also include and maintain information of the new lot in the distribution record.

You also need to carry out performance validation of the test kits that are in the market by taking samples of test kits from the market and sending them to the laboratory for testing.

For any enquiry please email to mdb@mda.gov.my .

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