Singapore and Malaysia registration for EU MDR-certified software
You already have CE marking and a technical file. I help you choose the route in each country, turn your EU documentation into the ASEAN dossier format, and prepare the submissions to HSA and MDA.
- Price
- Quote after scoping
- Regulators
- HSA Singapore · MDA Malaysia
- Starting point
- EU MDR certificate and technical documentation
- Experience
- Malaysia MDA registration and GDPMD for a SaMD
Who this is for
- Manufacturers of CE-marked software devices (Class IIa or higher under EU MDR) planning Singapore or Malaysia
- Teams that want one documentation base for the EU and Southeast Asia instead of separate files
- Companies that have a distributor or partner in the region and need the regulatory side organised
Not CE-marked yet? Start with EU MDR consulting, and we can plan the Asian submissions into the same documentation from the beginning.
Why EU MDR evidence helps
Singapore and Malaysia both follow the ASEAN Medical Device Directive: risk classes A–D and the Common Submission Dossier Template (CSDT) for the technical dossier. Neither recognises CE marking automatically, but both give weight to it:
- Singapore: HSA treats EU Notified Bodies as one of its reference regulatory agencies. Approvals from reference agencies can open shorter evaluation routes (abridged, expedited or immediate, depending on class and approvals held).
- Malaysia: MDA’s verification route lets a conformity assessment body verify an existing approval from a recognised jurisdiction instead of a full assessment. MDA’s guidance lists EU Notified Body certificates under MDR among the qualifying approvals, and since 1 March 2026 HSA approvals also qualify (full implementation after a pilot).
The two routes at a glance
Published by the regulators; check the current versions before you plan, as fees and target timelines change.
| Singapore (HSA) | Malaysia (MDA) | |
|---|---|---|
| Law | Health Products Act and Health Products (Medical Devices) Regulations 2010 | Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012 |
| Who applies | A local registrant (a company registered in Singapore); importers and wholesalers also need HSA dealer’s licences | An authorised representative licensed and domiciled in Malaysia, holding an establishment licence |
| Dossier | CSDT (HSA guidance GN-17) with HSA’s registration templates (GN-15) | CSDT, declaration of conformity in MDA’s format, submitted through MeDC@St |
| Use of EU approval | Reference agency approval can qualify for abridged, expedited or immediate routes | Verification route by a conformity assessment body, based on an EU MDR certificate or HSA approval |
| Published target timelines | Abridged evaluation: 100 / 160 / 220 working days for Class B / C / D (full evaluation is longer); the clock stops while HSA waits for your answers | Conformity assessment body: about 1.5 months for verification; MDA: 30 working days for Class B–D after a complete application and payment |
Sources: HSA medical device registration overview and fees and turnaround times pages; MDA guidance MDA/GD/0070 (2nd edition, October 2025) and MDA announcement on HSA approvals (2026). Checked 27 October 2026. Details for software, for example cloud hosting and dealer licensing, are in the Singapore and Malaysia guides.
What you get
Planning
- Route assessment — class under each regime, available routes and the order of submissions (Singapore first, Malaysia first, or in parallel)
- Gap check of your EU documentation against CSDT and the local requirements
- List of local roles you need to appoint, and the questions to ask candidates
Submissions
- CSDT dossier assembled from your EU MDR technical documentation, with country-specific additions
- Declarations and forms in each regulator’s format, prepared for your signature
- Support with the submission made by your registrant or authorised representative, and with regulator or conformity assessment body questions
- Post-registration duties — a summary of change notification, vigilance and labelling obligations
Who does what
| Activity | Your team | Local registrant / authorised representative | Me | HSA / MDA / conformity assessment body |
|---|---|---|---|---|
| Choosing the route | Decides | Advises on local practice | Assesses options | — |
| Technical content | Provides and approves | — | Builds the dossier | Evaluates |
| Submitting the application | Signs declarations | Applies and holds the registration | Prepares the package | Decides |
| Import, distribution, local licences | Contracts partners | Licences, GDPMD in Malaysia | — | Licenses, audits |
I do not act as a local registrant, authorised representative, importer or distributor. You appoint these partners; I can help you prepare the questions for choosing them.
What I need from you
- Your EU MDR certificate(s), declaration of conformity and technical documentation
- Clinical evaluation, risk management, software and cybersecurity documentation
- Labelling and instructions for use, and any local-language needs
- Details of your registrant or authorised representative, or your shortlist
- Your intended launch order and dates
Price and timing
Quoted after a scoping call, as a fixed fee per country or for both. It depends on the device class, the route, the state of your EU documentation and how many products are included.
Regulator fees, conformity assessment body fees and the costs of your local partners are separate. Evaluation time is set by the regulator and the conformity assessment body; the table above gives their published targets.
Questions about Singapore and Malaysia
No. Each country requires its own registration. Your EU MDR certificate and technical documentation make it easier: HSA treats EU Notified Bodies as reference agencies, and MDA accepts EU MDR certificates for its verification route.
Not necessarily. MDA’s verification route accepts an EU MDR certificate as well as an HSA approval, so a CE-marked device can go to Malaysia directly. The best order depends on your commercial plans and partners.
No. Singapore requires a local registrant and Malaysia an authorised representative licensed in the country. You appoint them; I prepare the technical dossier and support them and you through the process.
Preparing the dossier depends on your documentation. Evaluation is set by the regulators: HSA publishes target turnaround times in working days that exclude the time it waits for your answers, and MDA publishes 30 working days for Class B–D after a complete application, plus the conformity assessment body’s verification. I don’t promise approval dates.
Malaysia and Thailand moved their reliance programme to full implementation in May 2026. I can include Thailand or other ASEAN markets in the route assessment, and we agree the scope case by case. ASEAN overview.
Planning Singapore or Malaysia?
A free 30-minute call about your device class, routes and partners.