Updated Guidelines for Covid-19 Test Kits

MDA has updated the information regarding the lot-to-lot variant performance for Covid-19 test kits. The conditional approval for the import and distribution of the approved medical device listed in Appendix I is valid for one year.

The establishment must also include and maintain information about the new lot in the distribution record.

Furthermore, the establishment shall collect data related to the safety and performance of the medical device and submit a report to the Authority regularly, or when required. The test kit shall comply with the labeling requirements specified in the Sixth Schedule of the Medical Device Regulations 2012, particularly instructions for use and disposal methods. This includes using an infographic for the instruction for use to ensure it is easily understood by laypersons. It is crucial to distribute the medical device only to licensed community pharmacies and healthcare institutions, which may then sell the medical device online in adherence to the distribution methods specified by the manufacturer.

Establishments should establish and maintain a post-market surveillance system to monitor medical device traceability throughout the supply chain. The Authority reserves the right to visit or inspect the establishment at any time and without prior notice. If the establishment fails to comply with any conditions imposed by the Authority, the Authority may revoke the conditional approval or take legal action. In summary, all information related to this medical device, including all supporting documents, must be kept on the premises and must be made available to the Authority upon request.