Requirements For Supplying Covid-19 Rapid Self-Test Kits In Malaysia
New requirements for supplying COVID-19 Rapid Self-Test Kits in Malaysia were released by the Malaysian Medical Device Authority (MDA) on 10 November 2021 in Guidance Document MDA/GD/0059. The document guides companies on the requirements to follow in order to place Covid-19 Self-Test Kits on the market. This guidance is separate to the guidelines for conditional approval of Self-Test Kits which can be found in MDA/GL/05. Please note that this guidance does not apply to COVID-19 test kits for professional use only.
i.Requirements for the establishment (manufacturer, importer, distributor)
- Shall have a valid MDA establishment license with the scope of In-Vitro Diagnostic (IVD) stated on the Good Distribution Practice of Medical Device (GDPMD) certificate;
- Shall first obtain a Conditional Approval Letter from the MDA as stated in the MDA Guideline No. MDA/GL/05 regarding Conditional Approval for COVID-19 Rapid Test Kit (self-test);
- Shall comply with labeling requirements as stipulated in the Sixth Schedule of the Medical Devices Regulations 2012 which are:
- to provide labeling in Bahasa Malaysia as it is a home-use device;
- to provide a QR code on the label which redirects to the Instructions For Use, and captures information such as the purchaser (name and contact information), date and time of purchase, and the premises where the purchase is made;
- to provide information on the disposal methods and reporting mechanism, together with medical device information such as name, brand, conditional approval letter reference number, batch/lot number or serial number.
- Shall provide video tutorials, as well as infographics, to facilitate users’ understanding of safe use of self-test kits, disposal methods, and actions to be taken if test results are positive/negative/invalid; and
- Shall collect data related to the safety and performance of the medical device, and report it to the MDA every month. The template for data collection on safety and performance can be found in Annex A of Guidance Document No. MDA/GD/0059
ii.Requirements for offline selling of COVID-19 Rapid Self-Test Kit
COVID-19 Rapid Self-Test Kit shall only be sold by:
- licensed pharmacies licensed with Pharmaceutical Services Division, Ministry Of Health (MOH)
- private healthcare institutions (clinic or hospital) licensed with Private Medical Practice Control Section (CKAPS), MOH
- other premises registered with the Ministry of Domestic Trade and Consumer Affairs (KPDNHEP)
- establishments to another licensed establishments (with IVD scope in GDPMD)
- establishment to an individual user and
- establishments to companies/ government or private organizations/ educational institutions to supply use by workers, personnel, or students.
COVID-19 RTK (self-test) individual selling is strictly prohibited.
iii.Requirements of online selling of COVID-19 Rapid Self-Test Kit
Covid-19 Rapid Self-Test Kit could be sold online by parties or establishments mentioned in part II. 1, II.2, II. 4, II. 5, and II.6 above. However, deliveries shall be carried out by suitable logistic providers with the assurance of safety and performance of the medical device.
iv.Requirements on storage and stock handling
The establishment shall ensure that proper training is provided, and sellers of COVID-19 Rapid Self-Test Kit have complied with the requirements of storage and handling according to manufacturers’ instructions to maintain the integrity of the product and prevent deterioration.
v.Requirements on the disposal of COVID-19 Rapid Self-Test Kit
Shall ensure that proper disposal procedure is in place, preferably using infographics or videos to be easily understood by the general public.
vi.Requirements for advertisement
The advertisement of unregistered Rapid Self-Test Kits is strictly forbidden. Advertisements for registered products shall only mention price, a product pictorial representation, brand and/or company name, and logo. It must not contain any product claims or descriptions. Usage of a replica of the packaging as approved by the MDA during conditional approval is also allowed. The use of the MDA logo on the product, packaging, advertisement is also strictly forbidden.
Establishments are required to set up and maintain a post-market surveillance system to monitor the traceability of the medical device throughout the supply chain, as stipulated in Chapter 3 of the Medical Devices Act 2012 (Act 737) and the Medical Devices (Duties and obligations of establishment) Regulations 2019. The establishment may refer to the following documents for post-market activity:
- MDA /GD/0011, Complaint Handling;
- MDA /GD/0012, Distribution Record;
- MDA /GD/0013, Field Corrective Action;
- MDA /GD/0014, Mandatory Problem Reporting; and
- MDA /GD/0015, Medical Device Recall.
If you have any queries regarding the requirements for the supply 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 email@example.com or by clicking the button below.