Registered in Singapore? Malaysia now accepts that work.

A pilot became permanent policy on 1 March 2026.

The Medical Device Authority and Singapore's Health Sciences Authority ran a six-month reliance pilot from 1 September 2025 to 28 February 2026. It worked. On 1 March 2026 MDA announced that applications for Class B, C and D devices already registered on the Singapore Medical Device Register (SMDR) continue to be accepted through the Verification Route — submitted via MeDC@St under guidance document MDA/GD/0070, “Conformity Assessment by Way of Verification Process”.

For a foreign manufacturer that treated Singapore and Malaysia as two unrelated submissions, this is the most consequential ASEAN change of the year. The work you paid for once is now worth something twice.

What the route actually replaces

Malaysian device registration has four moving parts. The Verification Route touches exactly one of them. Being precise about which one is the difference between a plan that works and a shipment stuck at the port.

One step gets shorter. Three do not. Anyone describing this as “automatic recognition” or a way to skip Malaysian registration is describing something that does not exist.

Who this is worth money to

• Manufacturers already on the SMDR — the dossier is built, the approval exists, and the Malaysian conformity assessment stops being a second full review.
• Companies entering both markets — sequencing is now a cost decision. Register in the market whose assessment your evidence best supports, then rely into the other. We model both orders before you commit.
• Distributors negotiating with a principal — an SMDR listing on the manufacturer's side materially changes your Malaysian timeline, which is worth raising before you sign exclusivity.

It is worth less to you if your device is Class A (no CAB assessment to shorten), or if your HSA registration was itself obtained through an abridged route with thin underlying evidence — verification still looks at what sits behind the approval.

How we run it

1. Eligibility check — we confirm the SMDR listing, the Singapore risk class against the Malaysian class, and whether the HSA approval covers the same device configuration and intended purpose you want to sell here. Class mismatches are the usual reason a verification submission gets pushed back to full assessment.
2. Business-side readiness in parallel — establishment licence, GDPMD and authorized representative arrangements start immediately, because they are the long pole and the route does not shorten them.
3. Verification submission — dossier assembled to MDA/GD/0070 expectations and lodged with the CAB, with the HSA approval and SMDR evidence mapped to Malaysian requirements.
4. MeDC@St filing and query handling — MDA application, queries answered on your behalf, certificate handed over with a renewal calendar.

It runs both ways — which makes sequencing a costed decision.

The reliance arrangement is reciprocal. A device registered with MDA through full conformity assessment can be submitted to Singapore's HSA under its Abridged evaluation route, with reduced documentation. MDA's announcement establishes the reciprocity; the specific documentation reductions on the Singapore side come from industry reporting since the pilot rather than from a published MDA service level, so treat the detail as indicative and the direction as settled.

For a manufacturer entering both markets, that turns a question people usually answer by habit — “Singapore first, obviously” — into an actual calculation. The market you register in first is the one that pays for the full assessment; the second inherits it. Which order is cheaper depends on three things:

• Where your evidence is strongest. Lead with the market whose assessment your existing dossier already satisfies. A file built for one regulator's expectations does not become neutral by being submitted somewhere else first.
• Where you need revenue first. Reliance shortens the second market, not the first. If Malaysia is the commercial priority, registering in Singapore first to “save money later” delays the revenue that matters.
• What entity you already have. Malaysia requires a local authorized representative and a licensed establishment; Singapore has its own local-presence requirements. Sequencing into the market where you already have a legal entity usually beats the assessment-fee arithmetic.

We model both orders before you commit to either — including the case where the answer is that reliance saves you nothing and you should simply register where you sell.

What it costs

Our published all-inclusive registration fees apply unchanged — RM6,000 per Class B device and RM9,800 per Class C device, with CAB and MDA fees inside the number. We do not quote a separate “verification route” product. Where verification reduces the CAB fee for your specific device, that reduction shows up in your written quotation rather than in our margin; where it does not, you are not paying extra for the pathway. Full schedule on the pricing page and the cost guide.