Singapore legislation
Regulation 3
of Health Products (AI Standalone Mobile Application — Exemption) Order 2026
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:
the AI standalone mobile application falls under Class A (low risk) or Class B (moderately low risk) of the Third Schedule to the Regulations;
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;
the AI standalone mobile application is intended for use —
by X, if X holds a licence under HCSA, to provide a healthcare service that X is licensed under HCSA to provide; or
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;
X notifies the Authority of its manufacture of the AI standalone mobile application prior to or at any time during its manufacture;
where the AI standalone mobile application is jointly manufactured with another person — that person is a public healthcare entity.