Singapore’s HSA
Medical Devices
Singapore’s Health Authority:
In Singapore, medical devices are regulated by the Medical Device Branch of the Health Sciences Authority (HSA). In 2007, the HSA passed the Health Products Act, allowing them to conduct mandatory product registration and regulate the supply, distribution, manufacturing, import, and advertisement of all health products.
Medical Device Definition:
They are defined as health products which have a physical or mechanical effect when used on human bodies and are used to: Diagnose, alleviate or treat a medical condition, e.g. X-ray machines; Measure or monitor functions of the body e.g. glucometer; Products which are used to maintain or support general well-being, such as body toning equipment, magnetic accessories and massagers, are NOT medical devices and hence not regulated by HSA.
Medical Device Registration Process:
All medical devices and pharmaceutical products imported and/or sold in Singapore must be registered, regardless of risk class (except those exempted from registration). The licensing of dealers (manufacturers, importers, and wholesalers) is also mandatory.
More Resources:
- For more information on the Medical Devices and our Services in Singapore please click the “Read More” Tab.
- Registered medical devices are listed on the Singapore Medical Device Register (SMDR), which is publicly available on the HSA’s website.
Pharmaceuticals
In Singapore, therapeutic products, known as western medicines, are required to be registered with the Health Sciences Authority (HSA) before they can be supplied in Singapore. The Health Products Act (HPA) regulates the manufacture, import, supply, presentation and advertisement of therapeutic products.
Therapeutic Product Definition:
Under the First Schedule of the Health Products Act, the definition of a therapeutic product is separated into its intended use, constituent active ingredients, its inherent effects, and lastly defines what it is not (i.e. medical device, whole blood).
A therapeutic product is intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes: for preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical or mental state, or any symptom thereof ; for investigating, modifying, or replacing any physiological process; for influencing, controlling or preventing conception; or for inducing anesthesia.
Related Links:
- Guideline on Therapeutic Product Registration.
For more information on the Registration process click the “Read More” Tab.
Cosmetics
In Singapore, cosmetics are regulated by Health Sciences Authority (HAS) that is operating under the Ministry of Health. In addition to HSA regulations, companies must comply with Health Products (Cosmetic Products- ASEAN Cosmetics Directive) Regulations as well.
Cosmetic Definition:
Cosmetics are defined as “any substance or preparation that is intended to be placed in contact with the external parts of the human body e.g. skin, hair, nails, lips, or mouth including gums, teeth, tongue, for the purpose of cleaning them, perfuming them, changing their appearance, correcting body odors or protecting them or keeping them in good condition.” Singapore is one of the world’s most affluent markets in Asia and is considered a Showcase-Market for the introduction of Cosmetics to the rest of Southeast Asia.
Related links:
Use the classification guide to check if your product is a cosmetic in Singapore. Click here.
Nutraceuticals
In Singapore, Nutraceuticals are known as “Health Supplements” and they are regulated by the Health Sciences Authority (HSA).
Health Supplement Definition:
They are defined as products used to supplement a diet, with benefits beyond those of normal nutrients, and / or to support or maintain the healthy functions of the human body.
Health Supplement Categories:
The Singapore health legislation on health supplements include three categories:
- Vitamins and Dietary Supplements,
- Functional Foods and
- Functional Beverages.
The products may include but not limited to: Vitamins, minerals, amino acids (natural and synthetic), substances derived from natural sources, like non-human animal and botanical materials in the forms of extracts, isolates, concentrates.
Importation of Heath supplements:
Currently, health supplements can be imported and sold without a license from this Authority. They are not subjected to pre-market approval by this Authority. Nevertheless, manufacturers and distributors of health supplements are advised to comply with the guidelines for health supplements set out by this Authority.