Self-test kits in Malaysia: glucose meters, pregnancy tests and HIV self-tests.
A self-test is used by someone with no technical training, so MDA treats the kit and its instructions as one safety system. The class depends on the condition being tested, and some self-tests cannot be registered without a Ministry of Health policy.
Short answer: self-test kits are in-vitro diagnostic medical devices and must be registered with MDA before they are imported or sold. Under MDA/GD/0001, pregnancy, ovulation and menopause tests are Class B and blood glucose self-monitoring is Class C. HIV self-tests are Class D and have their own guidance, MDA/GD/0065, which limits who may sell them.
Class and MDA fee by test
| Test | Used by | Class | MDA fee (application + registration) |
|---|---|---|---|
| Pregnancy self-test | Lay person | B | RM250 + RM1,000 |
| Ovulation (LH) urine test | Lay person | B | RM250 + RM1,000 |
| Menopause (FSH) urine test | Lay person | B | RM250 + RM1,000 |
| Blood glucose self-monitoring (finger prick) | Lay person | C | RM500 + RM2,000 |
| HIV self-test | Lay person | D | RM750 + RM3,000 |
| Cholesterol test | Point of care, trained staff | B | RM250 + RM1,000 |
| Portable blood glucose monitor, prothrombin time test | Point of care, trained staff | C | RM500 + RM2,000 |
Classes from MDA/GD/0001 Tables 14 and 15 and MDA/GD/0065 section 7.4. Fees from the Fifth Schedule of the Medical Device Regulations 2012. CAB fees are separate.
Why self-tests are classified higher
Rule 4 of the IVD classification rules puts a self-test in Class C, unless its result is not medically critical, or is preliminary and needs a follow-up laboratory test. Then it is Class B. MDA/GD/0001 lists pregnancy tests in Class B and blood glucose self-monitoring in Class C on that basis. The intended user written in the instructions matters too, and the IVD CSDT must state whether the test is for lay people or trained staff (MDA/GD/0004).
The Ministry of Health policy gate
Do this check before spending money on a dossier. MDA’s published IVD Q&A says registering an infectious-disease self-test needs a Ministry of Health policy first. It cited H. pylori antigen cassettes and urinary tract infection dipsticks as not allowed for self-testing, and noted no policy at the time for influenza or troponin I self-tests. For non-infectious self-tests, MDA said it had no specific restriction.
Blood glucose meters and test strips
MDA’s note on registering IVD analysers sets out three routes. An analyser on its own, without reagents, is Class A. An analyser registered together with its reagents follows the class of the reagents. An analyser with an independent measuring function that uses no additional reagent, such as a glucose sensor, is classified by the intended purpose of the analysis. In every case the reagents have to be registered in their own right. How meters, strips and control solutions are bundled affects how many applications you file, so settle the grouping under MDA/GD/0054 first.
What to prepare
- Class and grouping under MDA/GD/0001 and MDA/GD/0054.
- IVD CSDT under MDA/GD/0004, stating the intended lay users.
- QMS certificate of the legal manufacturer.
- CAB report and certificate. Class B, C and D go through a conformity assessment body.
- Labels and instructions with a Bahasa Malaysia translation.
- Declaration of Conformity and post-market history.
The full list is in our documents checklist. A recognised approval can move the device to the verification route, and WHO-prequalified IVDs may qualify for the WHO collaborative registration procedure. Once registered, consumer advertising needs MDA advertisement approval, and marketplace sellers should read our guide to selling devices online.
HIV self-test kits: MDA/GD/0065
HIV self-tests are the most tightly controlled self-test in Malaysia. MDA/GD/0065 (Second Edition, January 2025) adds these requirements to the normal IVD process.
| Requirement | What MDA/GD/0065 says |
|---|---|
| Quality systems | Manufacturer certified to ISO 13485 with IVD scope; AR, importer or distributor certified to GDPMD with IVD scope |
| Performance, blood samples | Sensitivity and specificity each not less than 99.0% |
| Performance, saliva samples | Sensitivity not less than 92.0%; specificity not less than 99.0% |
| Performance studies | Should align with ISO 20916 or another relevant international standard |
| Clinical evidence in the CSDT | Clinical performance report, layman usability report, and a comparison of self-test against professional test |
| Conformity assessment | CAB with IVD 0201 and IVD 0403 technical area codes; full assessment, or verification if the kit has a recognised pre-market approval |
| MDA evaluation | 30 working days from a complete application |
| Instructions for use | IFU date and version, “self-test use” on the IFU and pack, English and Bahasa Malaysia, infographic and video tutorial link, TEST NOW QR code and statement, disposal method, complaint contact |
| Label QR codes | One to an audio-visual guide on testing and disposal, one to the TEST NOW platform |
| In the pack | A sterile, single-use safety lancet suitable for lay users for blood kits, registered with the kit or separately, and a disposable bag |
| Incidents | Reported through MeDCReST, then investigated and corrected, with MDA told what action is taken |
Who may sell HIV self-tests
- To other businesses: an authorised representative or manufacturer may supply appointed distributors, public and private healthcare facilities, and NGOs collaborating with the Ministry of Health.
- To the public: only community pharmacies licensed with the Ministry of Health’s Pharmacy Services Programme, public and private healthcare facilities, and NGOs and their partners collaborating with the Ministry of Health.
- Online: only those community pharmacies and NGOs and their partners.
- Individuals: sale, physically or online, is strictly prohibited.
Supplying any self-test kit without registration is an offence, with penalties of up to RM200,000 and 3 years in prison. Our all-in fee per device, with CAB and MDA fees included, is RM6,800 for Class B, RM9,800 for Class C and RM12,000 for Class D. See pricing and the full IVD guide.
Adakah kit ujian kendiri seperti alat ujian gula dan kehamilan perlu didaftarkan dengan MDA?
Ya. Kit ujian kendiri ialah peranti perubatan diagnostik in-vitro dan mesti didaftarkan dengan MDA sebelum diimport atau dijual. Ujian kehamilan, ovulasi dan menopaus ialah Kelas B, pemantauan glukosa darah sendiri ialah Kelas C, dan ujian kendiri HIV ialah Kelas D. Label peranti kegunaan sendiri memerlukan terjemahan Bahasa Malaysia. Ujian kendiri HIV hanya boleh dijual kepada orang awam oleh farmasi komuniti berlesen, kemudahan kesihatan dan NGO yang bekerjasama dengan KKM. WhatsApp 010-206 2070.
Frequently asked questions
Do pregnancy test kits need MDA registration?
What class is a blood glucose meter in Malaysia?
What class is an HIV self-test kit?
Who can sell HIV self-test kits to the public in Malaysia?
Can HIV self-test kits be sold online?
Can we register an infectious-disease self-test?
Must self-test kit labels be in Bahasa Malaysia?
How much does self-test kit registration cost?
Have a self-test kit ready for Malaysia?
Tell us the test, the manufacturer and the approvals it already has. We handle the classification, dossier, CAB and MDA submission, and the Bahasa Malaysia labelling.