Change of Registrant Under GN-24 R2: Requirements, Fee and Timeline

1. Key takeaways

Yes, the Registrant can be changed. A change of Registrant in Singapore is handled under GN-24 R2, the Guidance on the Change of Registrant issued in July 2025, at an official fee of SGD 880 with a review period of 40 working days. The procedure requires cooperation from both the outgoing and the incoming Registrant, and it requires a letter of authorisation from the product owner in favour of the new Registrant, using the template in Annex 1 of GN-15. Timing matters: once a registration has been cancelled because the annual retention fee was overdue for 60 days, there is nothing left to change, and the only route back to market is a fresh registration application.

• One procedure, one purpose. GN-24 exists to change the holder of the registration, not to change the product.
• Fixed official parameters. SGD 880 and 40 working days, unchanged by the size or complexity of the portfolio.
• Two-party cooperation is the real dependency. The outgoing Registrant must act, and no fee makes it act faster.
• The authorisation must move with the registration. Withdraw the old letter of authorisation and issue the new one in the right order.
• Content changes run on a separate track. Product changes follow GN-21 R7 and are priced by class and change type.
• Cancellation is a dead end. A listing cancelled for non-payment cannot be transferred and must be re-applied for.

2. Legal basis

GN-24 R2 sets out the procedure, the fee and the review period for changing the Registrant. The supporting document is the letter of authorisation in Annex 1 of GN-15 R15, issued by the product owner to the incoming Registrant. The authorisation framework matters because the old authorisation does not lapse by itself: it continues in force until the product owner notifies HSA in writing that it is withdrawn. Product content changes are governed elsewhere, by GN-21 R7, which is also the instrument that limits how many change applications a single listing may have under review at one time.

3. Expert insights

GN-24 changes the person, not the product. Two procedures are often confused, and the distinction has to be settled before any filing is prepared. Changing the legal holder of the registration is a GN-24 matter at SGD 880 and 40 working days. Changing the content of the product is a GN-21 R7 matter, priced by class and change type: administrative changes at SGD 560 and 30 working days, Class C technical changes at SGD 1,890 and 75 working days, and Class D technical changes at SGD 3,120 and 90 working days. Where a transfer coincides with a product update, both procedures run, separately. GN-21 R7 also caps each listing at two change applications under review at any one time, so the filings have to be staggered rather than submitted together.

The 40 working days is a review clock, not a period of inactivity. As with all HSA reviews, the clock stops while the agency waits for the applicant to answer queries. The most common cause of delay in a transfer is the outgoing Registrant being slow to provide documents. That waiting time is not counted in the official period, which means the published 40 working days can stretch considerably in practice. Project plans should therefore separate the official review period from the cooperation period, and should treat the second as the less predictable of the two.

Withdrawing and reissuing the authorisation is the legal foundation of the transfer. Because the existing authorisation remains valid until the product owner withdraws it in writing, the standard sequence is: the product owner withdraws the authorisation given to the outgoing Registrant in writing; the product owner issues a letter of authorisation to the incoming Registrant; the GN-24 application is then submitted. Reversing the order creates an authorisation vacuum in which the incoming Registrant has no mandate and the outgoing Registrant may still appear to hold one. Getting the sequence right is a drafting exercise, and it should be documented in a short checklist that both parties sign up to before filing.

Supply arrangements during the transfer must be designed in advance. The legal status of the registration while the change is under review, who may continue to import and supply, and how existing inventory is handled all need to be settled before the process starts. These are not questions the regulator answers for the parties; they follow from the licence position of each entity and from the contracts between them. In transfer projects our first step is not the submission but a transition agreement that records those arrangements, because a supply interruption during the review window is commercially more damaging than the review fee.

A cancelled registration cannot be changed. Section 12 of GN-15 R15 provides that where the annual retention fee is overdue for 60 days, the listing is cancelled and import and supply must stop. Once that happens there is no registration left to transfer, and the product must be registered again from the beginning. This links transfer planning directly to payment discipline: a company that is behind on retention fees cannot execute a clean change of Registrant, and the cheapest way to protect a transfer is to keep the fee status current throughout.

4. Practical recommendations

• Negotiate an exit clause in the initial contract. Cover the cooperation obligation, the deadline and compensation for breach.
• Sign a transition agreement before filing. Record who supplies, who imports and how inventory is treated during the review period.
• Sequence the authorisation documents. Withdraw the old letter, issue the new one, then file GN-24, in that order.
• Separate transfer from product change. Run GN-24 and GN-21 R7 as distinct projects and stagger them against the two-application cap.
• Keep retention fees current during the transfer. A cancelled listing cannot be transferred and must be registered afresh.

5. Verification checklist

• □ The case is confirmed as a change of holder under GN-24, not a content change under GN-21
• □ Cooperation obligations of both Registrants are documented and accepted
• □ The sequence for withdrawing and reissuing the letter of authorisation is planned
• □ A transition agreement covers supply and inventory during the review
• □ Annual retention fee status is current, so the listing cannot be cancelled mid-transfer
• □ Budget and timeline reflect SGD 880 and 40 working days, plus cooperation time

Regulatory information verified as of 26 October 2026. Source tiers: secondary (GN-24 R2, GN-15 R15 Annex 1, GN-21 R7, HSA fees page).

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