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

The establishment must also include and keep 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 the report to the Authority regularly, or when required. The test kit shall comply with labelling requirements specified in the Sixth Schedule of the Medical Device Regulations 2012, especially instruction for use and disposal method. This includes the instruction for use using an infographic, to make it easily understood by lay persons. Important is to distribute the medical device only to licensed community pharmacies and healthcare institutions. They may then sell the medical device online subject to appropriate distribution method specified by the manufacturer.

An establishment shall establish and maintain a post-market surveillance system to monitor the traceability of the medical device 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 actions. In summary, all information related to this medical device, including all supporting documents, must be kept on the premises, and shall be made available to the Authority upon request.