HSA Letter of Authorisation under GN-15 R15 Annex 1

1. Key takeaways

The Product Owner authorises a Singapore-registered company to act as its Registrant by issuing a letter of authorisation on the HSA template published as Annex 1 to GN-15 R15, in the October 2026 version. The letter must be printed on company letterhead, signed by a senior officer, identify the devices it covers, authorise the Registrant to submit the application on the Product Owner’s behalf, and commit the Product Owner to providing post-market support. The authorisation remains valid from signature until the Product Owner notifies HSA in writing that it is withdrawn.

• The template is Annex 1 to GN-15 R15, Letter of Authorisation Template, October 2026. It is a prescribed form and should be issued substantially as published.
• Signature authority matters: the letter is signed by a senior officer of the Product Owner and issued on company letterhead, not by the Registrant and not by a local agent on the Product Owner’s behalf.
• Validity has no fixed expiry. The authorisation continues until the Product Owner withdraws it in writing to HSA, which makes the withdrawal clause the operative control.
• Changing the Registrant is a separate administrative procedure under GN-24 R2 (July 2025), at SGD 880 and 40 working days, and it requires cooperation from both parties.
• The Registrant and the Product Owner are both named in the Singapore Medical Device Register, so the relationship is visible to the market, not merely internal.

2. Legal basis

A foreign manufacturer cannot hold a Singapore registration in its own name. The registration is held by a locally registered company, and the legal link between that company and the product’s owner is the letter of authorisation. GN-15, Guidance on Medical Device Product Registration, sets the requirement, and R15 of October 2026 carries the current Annex 1 template. The document is short, but it carries three distinct legal functions at once: it establishes the Registrant’s standing to file, it defines the product scope that the filing may cover, and it binds the Product Owner to post-market obligations that continue after the certificate is granted.

Two features of this arrangement are easy to overlook at the drafting stage. The first is that the authorisation is not time-limited, so it does not lapse on its own and does not need renewal; the only exit is an active written withdrawal. The second is that the letter is filed with the submission and becomes part of the regulatory record, which means an inaccuracy in the covered device list persists for as long as the registration exists. Regulatory information in this article was verified to 26 October 2026 against secondary sources, namely GN-15 R15 with Annex 1 and GN-24 R2.

3. Expert insights

The letter is easy to enter and difficult to exit. Bringing an authorisation into effect takes a signature. Ending it requires a written notification from the Product Owner to HSA. The consequence is asymmetric in a way that matters commercially: if the relationship between the Product Owner and the Registrant breaks down, the Product Owner can withdraw unilaterally, and the registration held by the Registrant loses its legal foundation. When we review an agreement between a client and a local service provider, we read the letter of authorisation and the withdrawal clause of the commercial contract side by side, because a mismatch between them is where disputes begin.

The template has to be used as published, and self-drafted versions attract deficiency requests. HSA publishes the Annex 1 template and expects the applicant to issue it in that form. We have seen clients submit a self-drafted power of attorney that was in some respects more detailed than the template, and still be asked to reissue it, because certain mandatory elements of the prescribed form were missing. The workable division is to keep the template as the operative instrument and place any additional commitments in the commercial contract, where they belong and where they can be enforced between the parties.

The letter and the commercial contract must be separate but must not conflict. Our standard structure splits the two documents by function. The letter of authorisation satisfies the HSA format requirement and contains only the authorisation and the undertakings HSA expects. The commercial contract carries fees, access to the technical file, response times for queries, vigilance cooperation, confidentiality, and the terms for withdrawal and for transfer to a successor Registrant. Where the two documents address the same subject differently, the party holding the weaker position in a dispute is usually the one that drafted the contract without reading the letter.

The device scope must be stated clearly and must match the configuration list. The letter identifies the devices it covers, and our practice is to attach a device list that mirrors the configuration list filed with the dossier. That aligns three scopes that are otherwise managed separately: the registration scope, the authorisation scope and the grouping scope. When a new model is added later, the attachment is updated at the same time as the configuration list, so the three never drift apart.

Withdrawal of the authorisation does not transfer the registration automatically. Withdrawal only removes the legal basis on which the existing Registrant holds the registration. Moving the registration to a different Registrant requires the change of Registrant procedure under GN-24 R2, at SGD 880 and 40 working days, and it requires both parties to cooperate. That is the real cost of choosing the wrong Registrant, and it is paid at the worst possible moment, when the commercial relationship has already failed.

4. Practical recommendations

• Use the Annex 1 template from GN-15 R15 (October 2026) without deletions or rewording, and place any supplementary terms in the commercial contract instead.
• Cover both current products and those already planned for the near term within the authorisation scope, to avoid issuing the letter repeatedly.
• Negotiate withdrawal and transfer clauses in the commercial contract, including the duty to cooperate, the applicable timelines and the consequences of breach.
• Keep the device list attached to the letter consistent with the configuration list filed with the submission.
• Retain the signed original and the submission record, since both become evidence in any later change of Registrant or dispute.

5. Verification checklist

• □ Annex 1 template from GN-15 R15 (October 2026) used as the basis of the letter.
• □ Signed by a senior officer of the Product Owner on company letterhead.
• □ Covered device list stated and aligned with the configuration list.
• □ Commitment to provide post-market support included.
• □ Commercial contract addresses withdrawal, transfer of registration, fees and cooperation duties.
• □ Signed original and submission record archived.

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