Singapore regulations on healthcare products

1. Medical Devices (MD)

The definition of a particular healthcare product guides manufacturers and importers as to the scope of the regulated product.

In general, Medical Devices (MD) in Singapore are health products that have a physical or mechanical effect on human bodies. Mainly, such products are used for:

• Diagnosis, alleviation, and treatment of a medical condition (contact lenses, wheelchairs, X-ray machines, etc.);
• Measuring or monitoring functions of the human body (blood sugar monitoring machines, pregnancy self-testing, etc.);
• Supporting or sustaining life (heart valves, implantable defibrillators, etc.);
• In vitro diagnostics.

Singapore has defined risk classifications for medical devices, which determine registration and licensing requirements. There are four risk classes:

• Class A — low-risk devices (surgical masks, tongue depressors, bandages, etc.);
• Class B — low to moderate risk devices (contact lenses, dental crowns, hearing aids, etc.);
• Class C — moderate to high-risk devices (hip implants, X-ray machines, lung ventilators, etc.);
• Class D — high-risk devices (breast implants, heart stents, heart valves, etc.).

Key facts you should know:

1. Registrant must determine the risk class by himself via the on-line medical device risk classification tool.
2. No special permit is needed to advertise medical devices. The advertiser is responsible to ensure compliance with the legislation and guidelines for advertisement and promotion of MD.
3. All information on a label of MD must be in English.
4. There is post-market control of MD:

• • Every manufacturer, importer, supplier, or registrant of MD must maintain a record of every received complaint;
  • Every manufacturer, importer, supplier, or registrant of MD must report any adverse event to the HSA.

2. Therapeutic products (drugs)

Therapeutic products, also known as drugs or pharmaceuticals, are healthcare products for therapeutic, preventive, palliative, or diagnostic purposes. All drugs require registration and licensing by the HSA before they can be imported, manufactured, or sold wholesale in Singapore.

Key facts you should know:

1. Clinical trials are required for drugs in accordance with the HSA regulations.
2. No special permit is required to advertise therapeutic products.
3. It is mandatory for companies to report all serious adverse events regarding drugs.

3. Health Supplement

In Singapore, health supplements belong to the group of complementary health products that are regulated as healthcare products. A health supplement is a product used to supplement a diet with benefits beyond those of normal nutrients, and to support or maintain the healthy functions of the human body.

Typically, a health supplement consists of vitamins, minerals, amino acids, and botanical materials in the forms of extracts, isolates, or concentrates. It may be produced in capsules, soft gels, tablets, syrups, or liquids. Products presented in the form of food and beverages are not health supplements.

Key facts you should know:

1. Health supplements are not subject to approvals and licensing by the HSA for their importation, manufacture, and sales. However, importers, manufacturers, or wholesalers must ensure that their products are not harmful or unsafe.
2. There is post-market surveillance to monitor the safety of health supplements and to initiate timely product recalls.
3. There are several prohibitions concerning the addition of medicinal ingredients such as steroids in health supplements.
4. There are strict labeling standards for health supplements.

4. Cosmetic products

A cosmetic product is defined as any substance or preparation intended to be placed in contact with various external parts of the human body with a view to cleaning or perfuming them, changing their appearance, protecting them, or just keeping them in good condition.

Injections and eye drops, as well as products for treatment (e.g. creams against acne) are excluded from the cosmetic definition and are considered therapeutic products.

Key facts you should know:

1. In Singapore, cosmetic product manufacturers are not required to apply for a special licence. However, the manufacturer may apply for a Good Manufacturing Practice certificate to facilitate the export of its cosmetic products.
2. Labels or labeling statements must be in English and legible. All cosmetic products must comply with label requirements.
3. Singapore's regulations on the quality and safety of cosmetic products are similar to the requirements for such items in the European Union.
4. The company or person responsible for placing a cosmetic product in the market must notify the HSA of the place where the product will be marketed, of the place of manufacture, or of initial importation before the product is placed in the Singapore market.

5. Traditional Medicines (TM)

In Singapore, traditional medicines cover Indian and Malai traditional medicinal products. These products belong to a complementary health product group and are also regulated by the healthcare products regulations.

Key facts you should know:

1. Traditional medicines are not subject to approvals and licensing by the HSA for their importation, manufacture, and sales. However, importers, manufacturers, or wholesalers must ensure that their products are not harmful or unsafe.
2. To ensure that each production batch of TM is not contaminated with high levels of heavy metals, dealers should conduct heavy metals testing for every production batch.
3. There are strict labeling requirements for TM marketed in Singapore.

6. Chinese Proprietary Medicines (CPM)

Chinese proprietary medicines are considered to be complementary health products in Singapore. CPM refers to medicinal products that contain ingredients used in traditional Chinese medicine. CPM can be produced in the form of a finished product, i.e. tablet, capsule, etc., but not in the form of injection.

Key facts you should know:

1. A special permit from the HSA is required to advertise CPM or conduct any sales promotion activities.
2. Labeling standards differ from those applicable to the other types of health products.
3. Companies must report all serious adverse events.

7. Tobacco products

In Singapore, tobacco products are regulated by health products regulations. Tobacco products refers to cigarettes, shisha (waterpipe), cigars, and any product containing tobacco.

Key facts you should know:

1. Imitations of tobacco products, such as electronic cigarettes, are prohibited by law.
2. Chewing tobacco is also prohibited in Singapore.
3. Advertisements and promotions relating to tobacco products and imitating tobacco products are prohibited.
4. There are only six health warning labels that can be placed on tobacco product packages.