Integrated health regulation
We regulate health products, services, information, research and professionals, and facilitate biomedical industry development.
Last updated on 31 October 2026
What we oversee
Medical devices
Registration, licensing, change notification, adverse events, FSCA, advertisements
Therapeutic products
Registration, variations, reclassification, licensing, adverse events, clinical trials, advertisements
Cell, tissue and gene therapy products
Registration, variations, notifications, licensing, advertisement, product consultation
Cosmetic products
Classification, notification, ASEAN Cosmetic Directive
Chinese Proprietary Medicines
Product listing, licensing, advertisements
Traditional medicines
Labelling, ingredients, contaminants, advertisements
Health supplements
Safety and quality standards, claims, contaminants
Tobacco regulation
Licensing, suspended and revoked licences, report offences
Other regulation
Active ingredients, Clinical trials, Controlled drugs and psychotropic substances, Homoeopathic medicines, Medicated oils, balms and medicated plasters, Poisons, Topical antiseptics
<New> Health Services and Information Regulation
Health services
Healthcare Services Act, licensing, regulating, licensing conditions and codes of practice
Health information
Health Information Act, National Electronic Health Record (NEHR) contribution and access, sharing of non-NEHR health information, cybersecurity and data security
Regulation of biological agents and toxins
Biological Agents and Toxins Act, regulated materials and activities, applications, approvals, permits and notifications
Regulation of human biomedical research
Human biomedical research act, notification, serious adverse events, suspected offences or contraventions, declaration of compliance, TIARAS
Regulatory sandbox
Healthcare innovation, regulatory sandboxes, regulatory innovation, industry partnerships, patient safety
Watchlist
Enforcement actions