Health Products (AI Standalone Mobile Application — Exemption) Order 2026

No. S 66

Health Products Act 2007

Health Products
(AI Standalone Mobile Application —
Exemption) Order 2026

In exercise of the powers conferred by section 70 of the Health Products Act 2007, the Health Sciences Authority makes the following Order:

Citation and commencement

1.  This Order is the Health Products (AI Standalone Mobile Application — Exemption) Order 2026 and comes into operation on 13 February 2026.

Definitions

2.  In this Order —

“AI standalone mobile application” means a medical device that is an artificial intelligence software, and a standalone mobile application as defined in regulation 26(5) of the Regulations;

“cluster HQ” means any of the following:

(a) National Healthcare Group Pte Ltd;

(b) National University Health System Pte. Ltd.;

(c) Singapore Health Services Pte Ltd;

“HCSA” means the Healthcare Services Act 2020;

“healthcare service” has the meaning given by section 3 of HCSA;

“HPB” means the Health Promotion Board established under section 3 of the Health Promotion Board Act 2001;

“medical device” means a health product that is a medical device as defined in item 1 of the First Schedule to the Act;

“public healthcare entity” means any of the following:

(a) a public healthcare institution;

(b) a cluster HQ;

(c) Synapxe Pte. Ltd.;

(d) MOH Office for Healthcare Transformation Pte. Ltd.;

“public healthcare institution” means any of the following that holds a licence under HCSA:

(a) a subsidiary of a cluster HQ;

(b) a business registered by a cluster HQ under the Business Names Registration Act 2014;

(c) an entity managed and controlled by a cluster HQ;

“Regulations” means the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010).

Exemption from manufacturer’s licence requirements

3.  Section 12(1) of the Act does not apply to a public healthcare entity (X) that manufactures an AI standalone mobile application under all of the following conditions:

(a) the AI standalone mobile application falls under Class A (low risk) or Class B (moderately low risk) of the Third Schedule to the Regulations;

(b) the AI standalone mobile application is manufactured under the supervision of a clinician employed in a public healthcare institution and holding the position of consultant or higher;

(c) the AI standalone mobile application is intended for use —

(i) by X, if X holds a licence under HCSA, to provide a healthcare service that X is licensed under HCSA to provide; or

(ii) by another public healthcare entity that holds a licence under HCSA or by HPB (each Y), to provide a healthcare service that Y is licensed under HCSA to provide;

(d) X notifies the Authority of its manufacture of the AI standalone mobile application prior to or at any time during its manufacture;

(e) where the AI standalone mobile application is jointly manufactured with another person — that person is a public healthcare entity.

Exemption from registration requirements

4.—(1)  Section 15(1) of the Act does not apply to a public healthcare entity (X) that supplies (whether by itself or jointly with one or more public healthcare entities) an AI standalone mobile application manufactured by X under all of the following conditions:

(a) X manufactures the AI standalone mobile application by itself or jointly with one or more other public healthcare entities;

(b) the common conditions in sub-paragraph (3) are satisfied.

(2)  Section 15(1) of the Act does not apply to a public healthcare entity (X) that supplies (whether by itself or jointly with one or more public healthcare entities) an AI standalone mobile application not manufactured by X under all of the following conditions:

(a) the AI standalone mobile application is manufactured by one or more other public healthcare entities;

(b) the common conditions in sub-paragraph (3) are satisfied.

(3)  The common conditions are —

(a) the AI standalone mobile application falls under Class A (low risk) or Class B (moderately low risk) of the Third Schedule to the Regulations;

(b) the AI standalone mobile application is manufactured under the supervision of a clinician employed in a public healthcare institution and holding the position of consultant or higher;

(c) X supplies the AI standalone mobile application —

(i) by way of administration to or application in any person in the course of any diagnosis, treatment or test, if X holds a licence under HCSA to provide such healthcare service;

(ii) to another public healthcare entity (Y), for Y to supply the AI standalone mobile application to another public healthcare entity that holds a licence under HCSA or to HPB (Z), for Z to provide a healthcare service that Z is licensed under HCSA to provide; or

(iii) directly to Z, for Z to provide a healthcare service that Z is licensed under HCSA to provide;

(d) X notifies the Authority of X or Z’s deployment (as the case may be) for use of the AI standalone mobile application prior to such deployment; and

(e) the AI standalone mobile application is, prior to its deployment under sub-paragraph (d), endorsed for use in X or Z (as the case may be) by —

(i) if X or Z has both a medical board and a chief executive officer — either the chairman of the medical board, or the chief executive officer, of X or Z;

(ii) if X or Z has a medical board and no chief executive officer — the chairman of the medical board of X or Z;

(iii) if X or Z has a chief executive officer and no medical board — the chief executive officer of X or Z; or

(iv) if X or Z is HPB — the Chief Executive of HPB.

Made on 5 February 2026.

BENJAMIN ONG

Chairperson,
Health Sciences Authority,
Singapore.

[401:04/04-000; AG/LEGIS/SL/122D/2025/1]