Malaysia clamps down on COVID-19 test kits
The Medical Device Authority (MDA) made an announcement on Monday aimed at the general public and distributors: informing the public that the purchase of COVID-19 test kits is prohibited; and to inform distributors that COVID test kits must use the special access route for registration and that they are only for distribution specifically to healthcare facilities as selling to public is strictly prohibited.
The MDA reminded all concerned parties that test kits for COVID-19 are medical devices regulated under the Medical Devices Act 2012 (Act 737). In an emergency situation such as the current COVID-19 pandemic, COVID-19 test kits are exempt from registration through the Medical Devices (Exemption) Order 2016. However, any party wishing to import or supply COVID-19 test kits must notify the MDA to obtain permission to import or supply for use in Malaysia.
Upon receiving notification from the applicant, the test kits to be imported and supplied will go through an evaluation process by the COVID-19 Test Kit Evaluation Specialist Committee. This committee was established to assist the MDA in setting criteria and conducting safety and performance assessments of the test kits. After the assessment is made, the Committee will recommend whether a test kit can be used for the purpose of COVID-19 detection based on the criteria and evaluation conducted. Any test kit that does not get permission from MDA does not go through the evaluation process and thus its safety and performance cannot be guaranteed.
The MDA reiterated that only test kits that have passed the assessment based on the fixed criteria will receive a “recommended for use” recommendation from the COVID-19 Test Kit Evaluation Specialist Committee and given permission through a “no restriction letter” to import or supply for use in Malaysia. Those who do not have permission to import or distribute the COVID-19 test kit from MDA are not allowed to import and distribute test kits in Malaysia.
The MDA also reminds the general public and distributors that permission given is only for the use of the test kits by medical professionals and they cannot be sold or distributed to the public. In this regard, the MDA would like to remind those who have obtained permission to import and distribute this test kit, to only distribute it to the health premises that have been listed in the “no restriction letter” issued by the MDA. Distribution of COVID-19 test kits to any party other than those listed in the “no restriction letter” is a violation of the conditions of authorization which may result in the “no restriction letter” being withdrawn and may be subject to action under subsection 5 (2) of the Act 737. Any person convicted of an offense under this subsection shall be liable to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding three years or both.
In addition, the MDA would also like to inform that the advertising of COVID-19 test kits in any media is not allowed. The display of test kit advertisements can encourage purchase among the general public and this situation is feared to increase the risk of infection as the general public does not have sufficient knowledge to interpret the test results obtained nor know how to handle the situation after obtaining the test results. COVID-19 infection detection tests should only be performed by qualified and trained health staff in recognized health facilities by the Ministry of Health to ensure that patient treatment is performed in accordance with established procedures and thus can trace the spread of the epidemic. Any person convicted of an offense in connection with the advertising of medical devices shall be liable to a fine not exceeding three hundred thousand ringgit or to imprisonment for a term not exceeding three years or to both under subsection 44 (3) of Act 737.
The MDA will continue to monitor the advertising, distribution and sale of COVID-19 test kits in the market including the sale and distribution through online platforms to ensure that the COVID-19 test kits on the market are safe and effective.
The public is advised to always take infection prevention measures as recommended by the MOH and that if there is a need to conduct a COVID-19 test, they are advised to undergo testing at a MOH-recognized health facility.
If you have any queries regarding updates published by the MDA, COVID-19 test kit authorizations or our services for medical device registration and representation in Malaysia, please click on the enquire now button below or send us an email to firstname.lastname@example.org