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TRANSITION OF CONDITIONAL APPROVAL APPLICATION AND SPECIAL ACCESS NOTIFICATION TO THE REGISTRATION PHASE THROUGH ONLINE APPLICATION (MEDC@ST) FOR COVID-19 TEST KIT
Since the outbreak of COVID-19 in Malaysia, the Medical Devices Authority (MDA) has taken the approach of granting temporary permission through Special Access Notification to suppliers wishing to supply medical devices directly related to the outbreak of COVID-19 including COVID-19 test kits for professional use.
As for the COVID-19 self-test kit, MDA has taken the approach of giving permission through Conditional Approval to any company that wants to import and distribute the test kit.
Taking into account the current situation, the MDA which met on 23 December 2021 has decided that from 1 February 2022, all COVID-19 test kits whether for professional use or personal use must be registered under Section 5 of the Medical Devices Act 2012 (Act 737) before placed on the market.
Accordingly, starting 31 January 2022, MDA will stop accepting applications for Special Access Notifications (COVID-19 test kit for professional use) and Conditional Approvals (COVID-19 self-test kit) manually. Any new application for approval for these two types of test kits must be made through registration under Section 5 of Act 737 using the Medical Device Centralized Online Application System MeDC@St online platform, effective 1 February 2022.
For COVID-19 self-test kits that have been granted permission through Special Access Notification and Conditional Approval, the letter of authorization can still be used until the expiration of the period specified in the letter. Any establishment that obtains this permission, can also apply for registration through the MeDC@St platform from 1 February 2022.
To provide clear guidance, MDA has prepared a guideline document related to MDA/GL/07 Guideline for Registration of COVID-19 IVD Test Kits which can be downloaded from the MDA website, www.portal.mda.gov.my. MDA will also conduct a series of briefings to establishments starting 27 January 2022 besides being able to book consultation slots through consultation@mda.gov.my.
Chief Executive
Medical Devices Authority
Ministry of Health Malaysia
24 January 2022
