KUALA LUMPUR: The Health Ministry's Medical Devices Authority (MDA) has granted conditional permission for the import and distribution of Covid-19 self-test kits into the country.
MDA chief executive Ahmad Shariff Hambali said in light of the rising concern over public health and safety, the government has agreed to allow importation of Covid-19 self-test kits for an independent detection process among the public.
He said this latest development comes after members on the MDA board felt that the self-test kits would help lower the hospital's burden in testing and allow members of the public to conduct self-assessments independently.
"The conditional approval comes with compulsory import requirements which include licencing, and to have a clear and easy-to-understand instructions for use and disposal methods, with the implementation of a safety monitoring system and test kit performance record.
"The self-test kit must also meet local technical test standards and performance tests here before it can be imported for commercial purposes," he said in a statement.
Shariff said, with today's decision, the public can easily test themselves and obtain the results immediately, before considering medical help at hospitals.
"This self-test kit, however, does not substitute the diagnostic real-time reverse-transcription polymerase chain reaction (RT-PCR) test. So far, the MDA has approved only two brand names, and 15 others are still pending a local assessment process," he said.
He said the list of approved self-test kits will be available on the MDA website.
"Any company that wishes to obtain this conditional approval must already have an establishment licence under the Medical Devices Act 2012 (Act 737).
"So far two Covid-19 self-test kits have passed the prescribed technical evaluation and performance testing and will be granted import and distribution permission in the near future. Meanwhile, another 15 Covid-19 self-test kits are undergoing performance testing in the laboratory," he said.
MDA also advised the public wanting to use these test kits in the future to use it according to the instruction contained on the labels to ensure that the kit is used properly and disposed of safely.
He said interested parties can obtain the application form from their website and return to MDA via e-mail at interimcovid19@mdb.gov.my.