SINGAPORE · MALAYSIA · MEDICAL DEVICES

Singapore–Malaysia Device Reliance 2026: Which Country to Register First

Manufacturers planning to enter Singapore and Malaysia together often ask which country to register in first. The HSA–MDA Medical Device Regulatory Reliance Programme lets a registration in one country serve as the basis for an application in the other, but each authority still receives, reviews and issues its own registration. The right sequence depends on the approvals you already hold, how those approvals were assessed, the product scope and your market plans. (Source: HSA regulatory reliance page)

The six-month pilot, which ran from 1 September 2025 to 28 February 2026, has ended. MDA announced that from 1 March 2026 it continues to accept Verification-route applications for Class B, C and D devices registered in Singapore, and HSA states that it is committed to ongoing implementation of the programme. This article covers eligibility and procedure in each direction, and keeps MDA’s October 2026 draft guidance consultation separate from the pathways now in force. (Sources: MDA announcement, 1 March 2026; HSA regulatory reliance page)

Separate the two directions; do not copy one country’s conditions to the other

The two directions are not symmetrical. The Singapore direction requires the MDA registration to rest on full conformity assessment by a CAB. If a device was registered in Malaysia through MDA’s Verification route on the strength of CE marking, US FDA clearance or another recognised approval, that registration alone does not show that GN-15 Section 6.1’s requirement of full conformity assessment by an MDA-recognised CAB is met. Section 6.1 does not address a device that later also obtains a full CAB assessment; confirm such cases with HSA. (Sources: HSA GN-15 R15, Section 6.1, p. 30; MDA/GD/0070, Annex 1)

For example, a manufacturer with an HSA registration that wants to expand to Malaysia should first map the HSA approval scope against the models it plans to sell, then ask the CAB to confirm eligibility for verification. A manufacturer holding only an MDA registration certificate should first establish whether it was obtained through full assessment or Verification; the certificate itself does not show the original assessment route.

Malaysia to Singapore: check eligibility down to the product version

Section 6.1 of GN-15, under Section 6 “Regulatory reliance”, provides that Class B, C and D devices assessed through full conformity assessment by an MDA-recognised CAB and registered with MDA qualify for the abridged evaluation route. The device must have MDA approval for a labelled use identical to the intended use for marketing in Singapore. (Source: HSA GN-15 R15, Section 6.1, p. 30)

The exclusions are worded slightly differently in two official HSA sources:

• GN-15 Section 6.1: devices incorporating registrable therapeutic/medicinal products; borderline products classified differently by MDA and HSA.
• HSA regulatory reliance page: devices with different classifications between MDA and HSA; Class D devices with registrable drugs in an ancillary role.

The web page’s “different classifications” is broader than “borderline products”. Where the two authorities assign a different risk class or product status, we suggest confirming with HSA whether the pathway can be used rather than assuming eligibility. (Source: HSA regulatory reliance page)

Documents required: the MDA medical device registration certificate (which, on this pathway, takes the place of the proof of reference agency approval normally needed for the abridged route), the Certificate of Conformity issued by the CAB, and all registration documents GN-15 requires for the abridged evaluation route. When submitting the product registration application in SHARE, select “Regulatory reliance Program: Malaysia Medical Device Authority (MDA)” under “Evaluation Route Determinants”; the abridged evaluation turnaround time then applies. (Sources: HSA regulatory reliance page; HSA industry briefing, 20 May 2026)

The dossier still needs a coherent line through intended use, design, specifications, risk and clinical/performance evidence. The MDA certificate replaces the proof of reference approval, not the technical content.

Singapore to Malaysia: MDA registration still follows CAB verification

MDA/GD/0070 (Second Edition, October 2025) lists HSA as one of eight reference authorities recognised for the Verification route, with the accepted approval being “Registered in the Singapore Medical Device Register (SMDR)”. Its exclusion table lists HSA Special Access Routes as not applicable. MDA’s announcement of 1 March 2026 limits this direction to Class B, C and D. Class A devices are exempt from CAB conformity assessment under the exemption order and do not use this route in any case. (Sources: MDA/GD/0070, Section 4.3 Table 2 and Annex 1 Table 5; MDA announcement)

The general Verification conditions also apply. In summary:

• the device to be marketed in Malaysia has the same design and intended purpose as the approved device;
• there have been no safety issues in the past year, such as deaths, serious deterioration in health or open field safety corrective actions (including recalls);
• the device has not been rejected or withdrawn by any recognised regulatory authority or notified body.

(Source: MDA/GD/0070, Table 1, pp. 8–9)

Start by confirming that the product to be filed matches the HSA approval in identity, models and intended use, then agree the verification documents with your local authorised representative (AR) and the CAB. Once the CAB has finished, the MDA registration application still has to be submitted in MeDC@St, with the same technical documents the CAB reviewed, and local market arrangements put in place.

How to read the official timelines

(Sources: HSA regulatory reliance page; MDA/GD/0070, Section 6.4)

These are official targets for the respective procedures. They should not be read as “approval guaranteed within 60 working days of first contact”, nor as a promise that every project achieves the same reduction.

Map both applications in a single evidence matrix

The matrix below is MediPass’s suggested way for manufacturers and the applicants in both countries to spot gaps; it is not an official form.

The point of the matrix is to expose evidence gaps. If the reference approval covers professional use only but the new-market version is for self-testing, list the differences in users, procedure and performance evidence and reassess the pathway. Choosing a filing sequence cannot make up for a lack of product consistency.

Singapore first, or Malaysia first?

Class B–D products already registered with HSA can look first at the Singapore-to-Malaysia direction; products registered with MDA after full CAB assessment can look first at the Malaysia-to-Singapore direction. Where neither registration exists yet, confirm classification, grouping and available reference approvals first, then compare launch timing and documentation gaps.

Other reference approvals matter too. MDA’s Verification route itself accepts approvals from EU notified bodies, US FDA, TGA, Health Canada, Japan’s MHLW, the UK MHRA, Thai FDA and HSA, so a product holding one of these does not necessarily need a Singapore registration first. (Source: MDA/GD/0070, Annex 1) Conversely, if you plan to use a Malaysian registration to enter Singapore later, the Malaysian side should go through full CAB conformity assessment rather than Verification. Where another reference agency approval is available for Singapore, compare that abridged route’s eligibility and documents as well.

If hospital procurement in Malaysia is more urgent, Malaysian market access can be the first goal while keeping the intended-use and evidence planning Singapore will need. A sound choice comes from comparing the two workable options for the specific product, not from assuming one country is always faster or cheaper. Each reliance programme sets its own conditions, so check again before entering a third country; see our article on Thai FDA recognition of Malaysia’s MDA.

October’s MDA draft guidance consultation versus the current pathway

On 21 October 2026 MDA published an “Announcement: Public Consultation on Updated Draft Guidance Documents Third Edition” on its website. The two guidance documents that govern the Verification route, GD/0068 (the CAB guide for verification) and GD/0070 (the establishment’s registration submission guide), are both currently in their second edition. The announcement invites industry and CABs to comment on updated drafts of both: for GD/0068, the introduction, scope and application, conformity assessment procedure and Appendix 2 (review and verification criteria for Class B, C and D initial certification and recertification); for GD/0070, the introduction, scope and application, conformity assessment procedure, table of fees, Annex 3 (Class A new and re-registration submissions) and Annex 4 (Class B, C and D CAB assessment and submissions). Comments run from 22 October to 4 November 2026, using the attached form sent to guidancedocument@mda.gov.my. (Source: MDA announcement, 21 October 2026)

Until final versions are issued with clear implementation arrangements, prepare projects under the current second-edition guidance and the pathway HSA has published. Changes in a consultation draft should not be treated as new eligibility rules, fees or filing obligations already in force, and the close of the comment period does not make them effective automatically.