Malaysian MDA announces end of Special Access Route for COVID-19 Test Kits
The Malaysian Medical Devices Authority (MDA) has decided that all COVID-19 test kits whether for professional use or for personal use must be registered under Section 5 of the Medical Devices Act 2012 (Act 737) before being placed on the market. This is effective as of 1 February 2022.
This means that as from 31 January 2022, the MDA will no longer accept applications for Special Access Notifications (COVID-19 test kit for professional use) or Conditional Approvals (COVID-19 self-test kit).
Any application for new approval of these two types of test kits must now be made through registration under Section 5 of Act 737 using the Medical Device Centralized Online Platform Application System MeDC@St022.
Covid-19 Professional-Use Test Kits which have already been granted permission through Special Access Notification as well as Covid-19 Self-Test Kits (RTK) which have already been granted Conditional Approval can still be used until the expiration date as stipulated in their respective letters of “No Restriction of Use” for Special Access Notification or the Conditional Approval.
Moreover, those Covid-19 Test Kits that have already been granted permission via Special Access Notification or via Conditional Approval and wish to register in full via is 30 working days and exempted for local laboratory testing, will benefit from faster approval: the turnaround time for documentary review is 30 working days and the products are exempted from local laboratory testing requirements.
To provide clear guidance, the MDA has prepared a guideline document, MDA/GL/07 Guideline for Registration of COVID-19 IVD Test Kits, that can be downloaded from the MDA website.
The MDA will also conduct a series of briefings to establishments starting 27 January 2022, as well as offer consultation slots through email@example.com
If you have any queries regarding the requirements for the supply of Covid-19 test kits or our services for medical device registration and representation in Malaysia, contact your Regulatory Affairs Specialist at Andaman Medical or click the button below.