Overview
In accordance with the MDA guideline MDA/GL/MD-01 and MDA/GL/IVD-1, all applications for registration must be submitted through the Medical Devices Online Centralized Application System (MeDC@St 2.0). There are two scenarios explained in the guideline applicable to COVID-19 test kits and assays only. Registration of COVID-19 test kits and assays does not require assessment by Conformity Assessment Bodies (CAB). This differs from the usual registration route. To ensure the performance of these test kits, the MDA has appointed Local Assigned Assessment Laboratories to verify the kits.
Scenarios
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SCENARIO (A) is applicable to COVID-19 test kits that have been recommended for use under special access or conditional approval.
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SCENARIO (B): COVID-19 test kits that are not listed on the MDA portal are considered new applications.
Both scenarios (A) and (B) require the establishment license. For scenario (A), the application must access the technical documents, including the Conditional Approval Letter/Special Access Notification, for registration.
In the event of a disagreement or the necessity for expert input in Scenario (B), if additional information or documents are required, MDA will return the application to the applicants. If the applicant complies with all requirements and MDA is satisfied, MDA will email the application for evaluation at an assigned testing facility. MDA will also email the application to the recommender.
A Not Recommended for Use letter will be issued after receiving the evaluation report from the testing facility.
The detailed procedure on how to register the COVID-19 IVD Test Kits can be found here - https://www.mda.gov.my/documents/guideline-documents/1910-gl-registration-covid-19-ivd-test-kits-published/file.html.
Additional Information
Type Approval impacted: MEDICAL
Date of published: 04/27/22