The Covid-19 assessment Committee Of experts has agreed that all Covid-19 test kit applications pending Conditional Approval and Special Access would be halted and that all future applications will be submitted using the Medcast online system. The deadline for applications pending in CA and SA is set for March 3rd, 2022. As a result, all establishments must submit an application through the Medcast system (online system) ―Medical Device Centralized Online Application System (MeDC@St 2.0)

Please refer to COVID application MDA guideline and Guidance Document Guideline (MDA/GL/MD-01, MDA/GL/IVD-1, MDA / GL / 07 and MDA/GD/0059 )

• Guideline for Registration of COVID 19 IVD Test Kits
• For the new lot number for the test kit obtained Conditional Approval Letter and for your information, the Covid19 self-test kit device can be sold in the market for lot number as per state in the conditional approval letter ONLY, if there are any changes for lot number for the same test kit, it need go through a lot to lot variation test with testing facilities. Please provide the below document for the process:

           1) Conditional Approval Letter

           2) Fill up the FORM C  Form C - Application Form For Conditional Approval For Self Test COVID-19 Test Kits (Lot To  Lot Variation Test)

           3) New IFU and Artwork Labeling

Any queries should be submitted via email [email protected]/ Contact Number : +603 - 8230 0376. To obtain further guidance in regards to this submission, establishment may make an appointments via [email protected].

-

In accordance with Medical Device Authority (MDA Malaysia Ministry of Health, Malaysia), MyMedicNews serves as the leading online media in the medical device industry for Malaysia and the ASEAN region. We provide a creative one-stop web portal to deliver the latest news and product development in the medical device industry. Through our portal, key industry players can deliver business information, product, and services effectively to relevant target audience.

Disclaimer: All content is for informational or educational purposes only, and does not substitute professional medical advice or consultations with healthcare professionals. Medical device advertisements and their content are intended for Healthcare Professionals only. More information related to Malaysia medical device news, products, registration, and regulations is available on Medical Device Authority.