MDA has decided to replace the requirement of lot-to-lot variation test for the approval of new lot of COVID-19 test kit 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 kit that will be placed in the market. The establishment shall also include and maintain information of the new lot in the distribution record.


In addition, the establishment shall also carry out performance validation of the test kits that are in the market by taking samples of test kits from the market and send them to the laboratory for testing.


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

 

 

Updated: 29 March 2022