HSA UDI Requirements and Phase Schedule under GN-36 R2

1. Key takeaways

Unique device identification in Singapore is implemented in phases under GN-36 R2, Guidance on Medical Device UDI System, issued in July 2022. Phase 0 took effect on 1 November 2022 and covered coronary stents, orthopaedic joint replacement implants and intraocular lenses. Phase 1 took effect on 1 November 2024 and covered all Class D general medical devices and IVDs. Phase 2 takes effect on 1 November 2026 and covers all Class C general medical devices and IVDs. Phase 3 takes effect on 1 November 2028 and covers all Class B general medical devices and IVDs. Class A devices remain voluntary. Devices for clinical research or investigation and custom-made devices are exempt.

• Four phases are in force or scheduled, running from November 2022 to November 2028, and each is tied to a device class rather than to a product category.
• Phase 2, on 1 November 2026, is the operative deadline for Class C devices and is close enough to affect projects already in progress.
• UDI data are registered under GN-36 R2 and integrated with the SMDR and SIDREG databases, so UDI work and registration work run in parallel.
• Class D has been mandatory since 1 November 2024, which makes any remaining Class D gap an existing deficiency rather than a planning item.
• Class A is voluntary, and the exemption list covers only clinical research or investigational devices and custom-made devices.

2. Legal basis

GN-36 R2, Guidance on Medical Device UDI System, of July 2022 establishes the UDI requirement and the phase schedule. It is supported by the FAQ on the Medical Device UDI System, updated on 18 July 2022. UDI data are registered in accordance with GN-36 R2 and integrated with the SMDR and SIDREG databases, which is the mechanism that links a device identifier to the registration record and to the public register entry. The phase schedule is set out below, and it is worth reading as a single sequence rather than as four separate announcements, because the same data preparation obligation moves down the risk classes over six years.

Regulatory information in this article was verified to 26 October 2026. GN-36 R2 and the UDI FAQ were checked against secondary sources; the phase scopes and exemptions rest on an industry compilation of the schedule and should be confirmed against the official HSA text before a compliance decision is taken.

3. Expert insights

The first of November 2026 is a live milestone for projects now in progress. Any Class C registration project starting in October 2026 is likely to reach certification on either side of that date. Our advice to clients is direct: a Class C project should treat UDI compliance as a launch blocker rather than as a task to be completed afterwards. If the UDI-DI has not been registered at the point the certificate is issued, the practical supply of the product is held up even though the registration itself exists. The two events need to coincide, which means the UDI work has to start early enough to finish first.

UDI and registration are two systems that interlock. UDI data are registered under GN-36 R2 and integrated with the SMDR and SIDREG databases. The integration is what makes sequencing matter. Registration and UDI registration have to move forward together, because obtaining the certificate and then beginning UDI work creates a gap in which the product cannot be supplied as intended. On the project schedule, UDI-DI allocation and data submission should run in parallel with the registration filing rather than after it.

Class D has been mandatory for some time, and no project in progress should assume otherwise. Phase 1 has covered all Class D devices since 1 November 2024. If a company’s Class D portfolio has not yet been brought into UDI compliance, the position is an accrued gap rather than an item awaiting a planning decision. The distinction matters internally as well as externally: a gap that is described as future work tends not to be resourced, whereas a gap that is described as an existing deficiency gets an owner and a date.

Class A is voluntary, which does not mean it is pointless. UDI is voluntary for Class A devices, but for companies with traceability requirements, particularly those supplying hospital consumable chains, voluntary adoption improves channel management. The distinction to hold on to is that this is a commercial decision, taken on operational grounds, and not a compliance obligation. Presenting it as a requirement overstates the regulation; presenting it as irrelevant understates the operational benefit.

The exemption list is narrow and should not be extended by interpretation. The exemptions cover devices for clinical trials or clinical research and custom-made devices. Routine commercial products are not exempt, including low-volume or niche products that a company may regard as special. When a client proposes an exemption argument, we test it against those two categories directly, because an assumed exemption discovered at the point of supply is considerably more expensive than one tested at the planning stage.

4. Practical recommendations

• Start UDI work immediately on any Class C project in progress, given that the 1 November 2026 date is close.
• Run UDI-DI allocation and data submission in parallel with the registration filing rather than sequentially after certification.
• Check each product against the exemption categories, which cover clinical trial or research devices and custom-made devices only.
• Take stock of Class D products against the 1 November 2024 requirement and record any gap as an existing deficiency with an owner.
• Assess Class A adoption on commercial grounds, noting that non-adoption remains compliant.

5. Verification checklist

• □ UDI effective date confirmed for the device class concerned.
• □ Class C projects have started UDI-DI allocation and data registration against the 1 November 2026 date.
• □ Class D products confirmed as UDI compliant, the requirement having applied since 1 November 2024.
• □ UDI registration and product registration filing progressing in parallel.
• □ Exemption status checked, covering clinical research use and custom-made devices.
• □ Class A position assessed on commercial grounds where voluntary adoption is considered.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Singapore. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with HSA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com