Self-testing IVD registration · Southeast Asia

Self-Testing IVD (Home-Use Tests) Registration in Five ASEAN Markets

Repackaging a professional assay into a single-use kit with a pictorial leaflet does not make it an approved home test. Self-testing changes the operator, the specimen collection, the interpretation of results and the consequences of misuse; more importantly, not every test is accepted for self-testing in every market. MediPass first confirms, market by market, whether your product can be filed for self-test use and at which class, then files and holds the registration through its own companies in five countries.

Singapore HSA · Malaysia MDA · Thai FDA · Vietnam MoH · Indonesia MoH

Check whether my product can be filed as a self-test See what we do →

Self-testing is an intended use, not a risk class

Whether the same professional assay can be filed for self-test use differs across the five markets. Some markets do not accept self-test filings for certain tests at all: an influenza A/B self-test, for example, is currently not accepted in Malaysia but is in the other four markets. Where self-testing is accepted, the class is still decided product by product: AMDD Annex 3 Rule 4 starts at Class C with a Class B exception, an influenza A/B self-test is Class B in Singapore, while an HIV self-test is expressly Class D in Malaysia.

So MediPass’s first step is not to look up rules but to hear your plan: which products, which countries, which users. From that we confirm for each market whether the product can be filed for self-test use, at which class, and whether a disease-specific procedure applies, before we quote.

Book a self-test feasibility check

What we do for self-testing IVDs

The first question in a self-test project is “can it be done”, then “how”. MediPass first confirms whether each target market accepts a self-test filing for your product, then connects classification, evidence and filing into one plan.

Step 01Use & feasibility

Confirm whether the product can be filed as a self-test, and the class in each market

You tell us the product and the target markets; we check for each one whether self-testing is permitted for that test, which classification rule applies, which class results and whether a disease-specific requirement applies (HIV self-tests, for example). Self-testing, home collection with laboratory analysis and professional point-of-care use are judged separately, by who performs which step rather than where.

The deliverable is a market-by-market feasibility conclusion: where a self-test filing is possible and at which class, and where it is not accepted or needs a dedicated procedure.

Step 02Evidence & gaps

Review the evidence item by item once the project starts

Before quoting, we only confirm whether the product can be filed and meets the basic local requirements; once the project starts we review the analytical, clinical and lay-user usability studies item by item. Self-test evidence must cover the whole user journey: enough specimen, correct application, reading within the time window, recognising weak positives and invalid results.

The review produces an evidence gap list marking what can be used as is, what needs bridging and what needs a new study.

Step 03Labelling & IFU

Check labelling, IFU and local-language translations

A self-test IFU must suit the comprehension of the intended user, say when to consult a healthcare professional and state what the test cannot answer. We help verify the local-language label and IFU translations so that they match the filed intended use.

Some markets restrict who may supply self-tests to the public and online sales; we flag these up front in the plan, while channel and promotional arrangements remain with you and your distributors.

Step 04Filing & holding

Filed and held by MediPass’s own companies in five markets

MediPass has its own licensed company in Singapore, Malaysia, Thailand, Vietnam and Indonesia. Each can act as applicant, authorised representative or local registration holder: submitting, answering regulator queries, maintaining the certificate and carrying post-market obligations. The registration stays independent of any distributor.

See the local entities and credentials in five markets.

Change of registrant and licence-holding services

Self-test classification and requirements in five markets

The five markets start self-test IVDs at a similar class, but whether a given test is accepted for self-testing, the wording of exceptions and disease-specific procedures differ. The table compares frameworks; each product still has to be confirmed market by market.

Market	Self-test classification basis	Feasibility and specific requirements
Singapore	GN-14 R3 Rule 4: Class C start, Class B exception, decided per product (influenza A/B self-test is Class B)	Professional approval is not consumer approval; the self-test use must be within the registration scope
Malaysia	MDA/GD/0001 s. 8.4: Class C start, Class B exception	Not every test is accepted for self-testing (influenza A/B currently is not); HIV self-tests are Class D under MDA/GD/0065 with dedicated requirements
Thailand	Class 1–4 under the AMDD IVD annex	Self-test use assessed product by product; HIV self-tests follow a dedicated procedure; pure self-collection kits treated as low risk
Vietnam	05/2022/TT-BYT Rule 4: Class C start, Class B exception	Procedure confirmed per product: Class A, B declaration, Class C, D registration
Indonesia	Permenkes 5/2026 Art. 55, Class A–D	Every class needs an izin edar; self-test use and disease-specific requirements verified separately

Singapore

HSA · GN-14 R3 Rule 4Self-tests start at Class C with a Class B exception

Rule 4 covers both self-testing and near-patient testing, starting at Class C with a Class B exception; the final class is decided per product. An influenza A/B self-test, for example, is Class B in Singapore. A professional-use approval is not an approval for consumer use.