On January 31, 2025, the Medical Device Authority (MDA) of Malaysia issued the 2nd edition of the guidelines (MDA/GD/0065) to guide companies on the requirements for pre-market, placement in the market and post-market activities for HIV self-testing kits (HIVST) in the Malaysian market.
The key updated contents of the guidelines are as follows:
1) Regulatory requirements for facilities handling HIVST
- Both manufacturers and Authorized Representatives (AR) must obtain establishment licenses based on their business activities and roles.
2) Performance requirements
- Specific performance criteria have been introduced for two types of samples as follows:
| Type of test to detect antibodies and antigens/antibodies (Based on specimen type) | Sensitivity | Specificity |
| 1) Using blood samples | Shall not be less than 99.0 % | Shall not be less than 99.0 % |
| 2) Using saliva samples | Shall not be less than 92.0 % | Shall not be less than 99.0 % |
3) Conformity assessment procedure
- Additional details on the conformity assessment process for the manufacture and import of HIVSTs, conducted by a designated Conformity Assessment Body (CAB), have been included.
4) Registration requirements and process flow of HIVST
- The MDA may reject application in the following cases:
* The HIVST is wrongly classified.
* Failure to provide additional information of the HIVST requested by the Authority within 90 days or any granted extension period.
* Submission of the application without the requested information, particulars, or documents.
* Non-compliance with registration requirements as evidenced by the provided documentation.
5) Instructions for use (IFU) requirements
- In case of issues related to the use of the HIVST, contact information must be included so that users can file complaints.
6) Additional requirements on labelling
- The HIVST label must include an audio-visual guide for the testing procedure and disposal methods, as well as a QR code linking to the TEST NOW platform for HIV result reporting and additional support.
Please refer to the attached document below.
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