On January 31, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition Guidance Document (MDA/GD/0065) on the placement of HIV Self-Test Kits (HIVST) in the Malaysian market. This updated guidance document introduces several key revisions affecting regulatory requirements, performance evaluation, conformity assessment, registration, labeling, and post-market surveillance.
Key Updates in the Second Edition
Regulatory Requirements for Establishments
- Manufacturers and Authorised Representatives (ARs) must obtain an establishment license appropriate to their business activities.
Performance Evaluation
- Specific performance criteria have been introduced for HIVST across two different sample types.
Conformity Assessment Procedure
- Additional details have been provided on the HIVST conformity assessment process with local Conformity Assessment Bodies (CABs).
Registration Requirements and Process Flow
- New circumstances under which the MDA may reject an HIVST registration application have been included.
Instruction for Use (IFU) Requirements
- Establishments must provide contact details in the IFU for end-users to report complaints or post-market surveillance (PMS) issues.
Additional Labeling Requirements
- HIVST labels must now include QR codes linking to audiovisual guides and the TEST NOW Platform.
Compliance and Market Placement
The revised guidance document provides establishments with comprehensive requirements for pre-market approval, market placement, and post-market activities. These include regulations on HIVST registration, establishment licensing, product labeling, sales, distribution, advertising, and post-market surveillance and vigilance activities.
Additional Resources
For further details, access the official Second Edition Guidance Document here:
https://portal.mda.gov.my/index.php/announcement/1507-second-edition-guidance-document-mda-gd-0065-placement-of-hiv-self-test-kit-hivst-in-malaysia-market
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