IVD registration · Southeast Asia

In Vitro Diagnostic (IVD) Registration in Five ASEAN Markets

Reagents, kits, calibrators, controls, analysers and companion software are classified under dedicated IVD rules in all five markets. The deciding factor is not the assay technology but what a wrong result would do to the individual and to public health. MediPass defines the product boundary, determines class and route market by market, maps your performance evidence to CSDT, and files and holds the registration through our own companies in all five countries.

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

Assess my IVD classification and route See what we do →

IVD class depends on what a wrong result would change

General device classification looks at invasiveness, contact site and duration of use. IVD classification looks at the disease tested, the population, who runs the test, whether the result is the key basis for diagnosis or treatment, and whether public-health risks such as blood-donor screening are involved. “The test never touches the patient” does not prove low risk, and “the assay is highly accurate” does not lower a class that the intended use triggers.

MediPass first writes the intended use as one statement that can run through all five submissions: analyte, specimen, population, user, setting and the action taken on the result. We then test it against each market’s IVD rules (HSA GN-14, MDA/GD/0001, AMDD Annex 3 and the Vietnamese and Indonesian rules), recording the clauses applied and excluded. Professional and self-test use, single reagents and complete systems, are argued separately.

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What we do for IVD products

From regulatory scope to local licence holding, MediPass delivers the full IVD registration through its own entities in five markets. A typical project runs through four steps.

Step 01Boundary & class

Define the product boundary and determine the IVD class per market

A testing solution often bundles a sampling device, an analyser, reagents and software, and each component needs its own boundary: generic laboratory items do not become IVDs by entering a lab, instruments and reagents may be classified separately, and combined systems take the highest risk of the final intended use. We then determine the class under each market’s IVD rules, applying the highest class where several rules apply.

At the end of this step you have the IVD risk class for each of the five markets and the classification rule each conclusion relies on.

Step 02Evidence & gaps

Map analytical and clinical performance evidence to CSDT

Analytical performance (detection limit, precision, interference, cross-reactivity, stability) and clinical performance (diagnostic sensitivity and specificity, method comparison, clinical cut-offs) answer different questions, and all five markets expect both. We map your existing reports to the local submission structure (HSA GN-18 R5, the MDA IVD CSDT and others) and mark what is usable as is, what needs explanation and what needs a new study.

Before quoting, we confirm whether the product can be filed in each target market; once the project starts we review the performance reports item by item, so you know which performance evidence still has to be generated before anything is filed.

Step 03Route & grouping

Plan application scope, assessment route and labelling

We decide which configurations, pack sizes and companion items can share an application, check eligibility for abridged or reliance routes based on reference-agency approvals, and review local labelling, IFU language and user restrictions at the same time. Route eligibility depends on approval scope and intended-use consistency, not on risk class alone.

Output: a market-by-market registration roadmap with number of applications, route, applicant entity, official fees and expected timelines.

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, so you keep control of your sales channels.

See the local entities and credentials in five markets.

Change of registrant and licence-holding services

IVD classification and registration requirements in five markets

All five markets have dedicated IVD classification rules with four tiers, but the treatment of low-risk IVDs and the filing procedures differ. The table compares frameworks; a specific product’s class still has to be argued rule by rule.

Market	IVD classification basis	Market-entry procedure	Low-risk IVD handling
Singapore	GN-14 R3 · Class A–D	HSA product registration (Class B–D)	Class A exempt from product registration; dealers still need an HSA dealer’s licence
Malaysia	MDA/GD/0001 · Class A–D	MDA product registration (Class A–D)	Class A exempt from CAB conformity assessment, but still registered with MDA
Thailand	AMDD IVD annex · Class 1–4	Listed (1) · Notified (2–3) · Licensed (4)	Class 1 still requires a Listed certificate
Vietnam	05/2022/TT-BYT rules · Class A–D	Class A, B: declaration number · Class C, D: registration certificate	Class A and B obtain a number through the declaration procedure
Indonesia	Permenkes 5/2026 · Class A–D	MoH marketing authorisation (izin edar)	Every class needs an izin edar; in-vitro reagents and calibrators are expressly within the device definition

Singapore

HSA · GN-14 R3IVD risk classification · GN-18 R5 IVD submission guidance

IVDs are classified under GN-14, not the general-device GN-13. Class A is exempt from product registration; Class B–D register under the GN-15 R15 routes with a CSDT dossier prepared to GN-18 R5 (October 2026).