What changed on 1 March 2026 — and why it matters for your SaMD

The Singapore–Malaysia medical device regulatory reliance programme began as a six-month pilot on 1 September 2025. On 1 March 2026, following the pilot's successful completion, Malaysia's Medical Device Authority (MDA) officially confirmed that the programme will continue permanently. This is not an extension — it is full implementation.

Under this programme, SaMD manufacturers whose devices are registered in the Singapore Medical Device Register (SMDR) can apply for Malaysian registration through the Verification Route — a significantly accelerated pathway compared to standard registration. Review time at the Conformity Assessment Body (CAB) drops from 60 working days under full assessment to 30 working days. Final MDA registration follows within another 30 working days. Total timeline: approximately 60 working days versus the standard 120+ days.

Why Singapore first? Singapore's HSA is one of Asia's most respected medical device regulators — and EU MDR CE marking is one of its accepted reference approvals. If you have EU MDR certification, the path to Singapore is significantly shorter than for companies without international approvals. And Singapore registration now unlocks Malaysia automatically.

The EU MDR → Singapore → Malaysia pathway: step by step

Step 1: EU MDR CE marking as your foundation

Singapore HSA accepts EU MDR CE marking as a reference approval in its evaluation process. This means your MDR technical documentation, clinical evaluation, and QMS serve as the primary evidence base for HSA registration — reducing the documentation burden significantly compared to companies without prior international approvals.

HSA's GL-04 Rev.4 (December 2025) aligns software documentation requirements with IEC 62304, ISO 14971:2019, and MDCG-equivalent guidance. If you have built your technical file to MDR Annex II/III standards, the majority of what HSA needs is already produced. Key additions include HSA-specific cybersecurity documentation, post-market surveillance procedures aligned with HSA's change management programme, and Singapore-specific labelling and IFU requirements.

Step 2: Singapore HSA registration via SHARE platform

Submit your product registration application through HSA's SHARE (Submission of Health Product Application for Registration & Evaluation) online system. Your Singapore-based Product Registrant (a licensed importer or distributor) must hold the registration on your behalf unless you are yourself a licensed importer in Singapore.

Classification under HSA follows a Class A–D framework. Most clinical SaMD falls into Class B or C. Class B devices target 120–180 day review timelines for complete submissions; Class C typically 180–270 days. EU MDR reference approval accelerates this in practice.

Once registered, your device is listed on the Singapore Medical Device Register (SMDR). This SMDR listing is the key that unlocks the Malaysian Verification Route.

Step 3: Malaysia MDA registration via Verification Route

With your SMDR listing, your Malaysian Authorised Representative (AR) submits to a licensed Malaysian Conformity Assessment Body (CAB) using the Verification Route, as outlined in MDA guidance document MDA/GD/0070. The CAB reviews your application within 30 working days — relying on HSA's prior regulatory assessment rather than conducting a full independent review. The CAB certificate then supports your MDA registration application, completed within a further 30 working days.

Your Malaysian AR must hold a valid Establishment Licence and Good Distribution Practice for Medical Devices (GDPMD) certificate. For Class B, C, and D devices — which is where most SaMD sits — the AR submits through MDA's MeDC@St online system with the SMDR certificate, CSDT dossier, and CAB certificate as the primary documents.

Timeline summary: EU MDR (existing) → Singapore HSA: 4–9 months → Malaysia MDA via Verification: approximately 3 months → Total ASEAN entry time from zero: approximately 7–12 months, depending on existing documentation quality and device class.

What HSA requires beyond EU MDR documentation

Your EU MDR technical file covers the majority of what HSA needs, but several additions are required for Singapore submission:

The Malaysia layer: what MDA adds beyond HSA requirements

Under the Verification Route, Malaysia does not conduct a full independent technical review — it relies on HSA's assessment. However, several Malaysia-specific requirements still apply:

Singapore as a gateway beyond Malaysia

The HSA–MDA reliance programme is part of a broader ASEAN regulatory convergence trend that extends beyond just two markets. Singapore HSA approvals are increasingly recognised as reference approvals across the region. As of 2026, Singapore registration supports or accelerates entry into:

This means that a single Singapore registration — built on your EU MDR technical file — can efficiently support entry into 5–6 ASEAN markets. For SaMD companies with EU MDR certification planning Asian expansion, Singapore is not just one market: it is the regulatory hub for the region.

Official sources & references