Singapore legislation

Regulation 4

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

Regulation 4

Exemption from registration requirements

Subregulation 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.

Subregulation 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.

Subregulation 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.

Read in full context — Health Products (AI Standalone Mobile Application — Exemption) Order 2026 →