Regulation 1
Citation and commencement
This Order is the Health Products (AI Standalone Mobile Application — Exemption) Order 2026 and comes into operation on 13 February 2026.
/akn/sg/act/sub_leg/2007/HPA-S66-2026
Health Products (AI Standalone Mobile Application — Exemption) Order 2026
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- Type
- Subsidiary Legislation
- Status
- In force
- Enacted
- 2007
- Sections
- 4
Quick answer
About this subsidiary legislation
Health Products (AI Standalone Mobile Application — Exemption) Order 2026 is Singapore Subsidiary Legislation, cited as Subsidiary Legislation HPA-S66-2026 2007, currently marked in force and first recorded in 2007.
Regulation 2
Definitions
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).
Definition
“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;
Definition
“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;
Definition
“HPB” means the Health Promotion Board established under section 3 of the Health Promotion Board Act 2001;
Definition
“medical device” means a health product that is a medical device as defined in item 1 of the First Schedule to the Act;
Definition
“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.;
Definition
“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;
Definition
“Regulations” means the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010).
Regulation 3
Exemption from manufacturer’s licence requirements
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.
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.
Common questions
- What is Health Products (AI Standalone Mobile Application — Exemption) Order 2026?
- Health Products (AI Standalone Mobile Application — Exemption) Order 2026 is Singapore Subsidiary Legislation, cited as Subsidiary Legislation HPA-S66-2026 2007, currently marked in force and first recorded in 2007.
- Is Health Products (AI Standalone Mobile Application — Exemption) Order 2026 still in force?
- Yes — Health Products (AI Standalone Mobile Application — Exemption) Order 2026 is currently in force.
- When did Health Products (AI Standalone Mobile Application — Exemption) Order 2026 take effect?
- Health Products (AI Standalone Mobile Application — Exemption) Order 2026 was first recorded in 2007.
- How many regulations does Health Products (AI Standalone Mobile Application — Exemption) Order 2026 have?
- Health Products (AI Standalone Mobile Application — Exemption) Order 2026 contains 4 regulations.
- Where can I read the official version of Health Products (AI Standalone Mobile Application — Exemption) Order 2026?
- The official text of Health Products (AI Standalone Mobile Application — Exemption) Order 2026 is published at sso.agc.gov.sg.