Healthcare Product Regulations in Singapore

Singapore’s healthcare industry has been recognized as among the best in the world. The demand for healthcare products within the country has been growing from year to year, and it is not limited by the local domestic population. This success is mainly attributed to strong regulatory governance.

The  Singapore government created regulations governing healthcare products to ensure their quality, effectiveness, and safety. In addition, these regulations also help restrict access to products that may be ineffective or even harmful.

This article provides an overview of Singapore’s regulations governing healthcare products that companies must follow when manufacturing, importing and selling these products. 

If you plan to register your healthcare business or apply for any license related to healthcare products, please contact Biz Atom. We can provide complete support to carry out your company plans and assist you with other regulatory business issues in Singapore.

Why Singapore’s healthcare industry is thriving

Singapore is considered a prominent health and medical hub in Southeast Asia. Its healthcare system is ranked 6th in the world and offers the 4th best healthcare infrastructure globally. On top of that, the country’s healthcare industry is thriving despite the ongoing global pandemic and is expected to keep rising. There are many reasons behind this growth:

• Government spending on healthcare continues rising (S$13.2 billion in 2020 and is expected to increase to S$36 billion by 2029).
• Foreign investors have used Singapore as a manufacturing base or regional headquarter to expand into the growing ASEAN healthcare market.
• Singapore is one of the few countries capable of exporting more pharmaceutical products (about US$8.1 billion in 2019) than it imports (US$3.19 billion in 2019).
• The country has one of the world’s most rapidly aging populations.
• There are more than 50 manufacturing facilities in the country, with eight of the world’s ten largest pharmaceutical firms owning plants in Singapore. Some of the major players include Abbott, GlaxoSmithKline, Novartis, and Pfizer, who account for more than 40 percent of Singapore’s regional market.    
• Singapore has some of the world’s best hospitals, such as the Singapore General Hospital, and leading international health and research organizations such as the American Association for Cancer Research, Duke University, and the Healthcare Information and Management Systems Society.
• Singapore is able to attract more than 500,000 medical tourists every year, which accounts for almost four percent of overall tourism receipts (US$1 billion – Interestingly, 60 percent of them are Indonesian patients.
• Singapore’s multidisciplinary and interdisciplinary approach has made the country a center for biomedical research and development (R&D) in Asia, with employment in the biomedical sector doubling in the last decade (over 24,000 people in 2019 or 20 percent of the manufacturing industry).
• The Singapore government offers a strong public healthcare system centered around three programs known as the 3Ms: Medisave, MediShield Life, and Medifund. These programs provide citizens with discounts of up to 80% at public health institutions.

Singapore’s main regulations for healthcare-related products

Following are the key regulations that may be useful for entrepreneurs who want to start their business in the healthcare sector in Singapore.

• Health Products Act;
• Medicines Act;
• Medicines (Advertisement and Sale) Act;
• Sale of Drugs Act;
• Poisons Act; and
• Tobacco (Control of Advertisement and Sale) Act.

All types of healthcare products are administered under these regulations. The Singapore government regularly reviews and updates these regulations. The latest changes were introduced in late 2020.

Singapore’s healthcare industry regulator

The national regulatory authority responsible for overseeing healthcare products in Singapore is the Health Sciences Authority (HSA). The authority also serves the administration of justice, secures the nation’s blood supply, and safeguards the public’s health.

HSA is a multi-disciplinary agency, but the division responsible for law enforcement in this sector is the Health Products Regulatory Group. It ensures that healthcare products available in Singapore meet the standards of quality, efficacy, and safety.

The group consists of the following clusters:

• Pre-market Cluster;
• Vigilance, Compliance & Enforcement Cluster (including audit and licensing & certification); and
• Medical Devices Cluster.

The types of healthcare products that are regulated in Singapore

Some types of healthcare products that HSA regulates are:

Medical devices

In Singapore, medical devices are health products with physical or mechanical effects when used on the human body. These devices are used for:

• Diagnosing, alleviating, or treating medical conditions, e.g., X-ray machines, contact lenses, prosthetic knee implants.
• Measuring or monitoring body functions, e.g., blood pressure or blood sugar monitoring machine.

Products used to maintain or support general well-being without a specific medical claim, such as toning devices, magnetic accessories, and massagers, are not medical devices.

 There are four risk classes of medical devices:

• Class A: low-risk devices (wheelchairs or tongue depressors).
• Class B: low to moderate risk devices (hypodermic needles or suction equipment).
• Class C: moderate to high-risk devices (ventilators or bone fixation plates).
• Class D: high-risk devices (heart valves or implantable defibrillator).

Some key facts about the medical device regulatory requirements:

• You must register your medical devices before you can make them available in Singapore. You can determine the risk class via the online medical device risk classification tool.
• All medical device dealers will need to apply for a dealer’s license before importing, manufacturing, and supplying their devices in Singapore. 
• No special permission is required to advertise medical devices. However, advertisers are responsible for ensuring compliance with laws and guidelines for advertising and promoting medical devices.
• All information on medical device labels must be written in English.

 Medical device licenses that you may require:

• Manufacturer’s license –  for processing, producing, or making any medical devices.
• Wholesaler’s license – for supplying medical devices in Singapore (including providing them to another party).
• Importer’s license – for importing medical devices into Singapore.

Therapeutic products

Therapeutic products, commonly known as pharmaceuticals, are health products intended for therapeutic, preventive, palliative, or diagnostic purposes. These products may contain chemical or biological substances as active ingredients, which exert their effects either pharmacologically, chemically, or by other physiological means.

Some key facts about the therapeutic product regulatory requirements:

• You must be a local company registered with the Accounting and Corporate Regulatory Authority (ACRA) to proceed with therapeutic product registration.
• Clinical trials are needed for drugs according to HSA regulations.
• No special permission is required to advertise therapeutic products.
• Companies must report all serious side effects related to drugs.

Therapeutic product licenses that you may require:

• Therapeutic Product Manufacturer’s License (TPML) – for manufacturing or assembling drugs.
• Form A Poisons License (FAPL) – for importing and storing products needed for the manufacture of licensed therapeutic products.
• Therapeutic Products Importer’s License (TPIL) – for importing therapeutic products.
• Therapeutic Products Wholesaler’s License (TPWL) – for wholesaling drugs in Singapore.

Note:

Companies do not need to obtain a TPIL or a TPWL for therapeutic products if they use them as clinical research materials in clinical trials. 

Health supplements

Health supplements in Singapore are products used to supplement the diet with benefits beyond normal nutrition to support or maintain the health functions of the human body. A health supplement cannot be an injectable or something that needs to be sterile (such as injections and eyedrops) or a meal or diet item.

A health supplement must also contain one or more or a combination of the following ingredients:

• Vitamins, minerals, or amino acids (both natural and synthetic); or
• Materials derived from nature, including non-human, animal, and plant materials in the form of extracts, isolates, concentrates.

Health supplements should be administered in small unit doses in dosage forms such as capsules, soft gels, tablets, liquids, and syrups.

Some key facts about the health supplement regulatory requirements:

• Health supplements are not subject to approval and license by HSA for their import, manufacture, and sale.
• Health supplements must not be labeled, advertised, or promoted for any particular medicinal purpose.
• Product labels on health supplements must be prominent and conspicuous. In addition, the information must be adequately and truthfully written in English.
• The advertising and promotion of health supplements do not need license approval, except for products classified as quasi-medicinal products (e.g., products containing only vitamins and minerals).

Chinese proprietary medicines

In Singapore, a Chinese proprietary medicine (CPM) refers to medicinal products in the form of finished products, such as capsules or tablets. Typically, a CPM also contains one or more active ingredients from plants, animals or minerals, or any combination of sources. All of these active ingredients have to be documented for use in traditional Chinese medicine.

The following types of products cannot be considered CPMs:

• Products that are injectable into the human body; and
• Products containing isolated constituents that are chemically determined as active ingredients.

Some key facts about the CPM regulatory requirements:

• You will need to have a product listing approval and a dealer’s license to import, wholesale, manufacture, or assemble CPMs for sale and supply in Singapore.
• If you import CPMs for export only, product listing and dealer licenses are not required, but you will need to apply for a permit for the import of CPM solely for re-export.
• There are several prohibitions concerning the addition of medicinal ingredients, such as synthetic drugs.
• You will need valid permission from the HSA before publishing medical advertisements relating to or promoting the sale of CPMs. 

CPM licenses that you may require:

• Manufacturer’s license –  for manufacturing or assembling CPMs. However, companies that already have this license do not require a wholesale dealer’s license to wholesale the CPM.
• Wholesaler’s license – for supplying CPMs in Singapore. However, if a company wholesales CPM solely for use as clinical research materials in clinical trials, the license is not required.
• Importer’s license – for importing CPMs into Singapore. However, companies that import CPMs solely for export or re-export to other countries do not need to apply for a CPM import permit.

Traditional medicines

In Singapore, traditional medicines (TM) refer to traditional Malay and Indian medicinal products. They are finished products containing ingredients with uses documented in the relevant TM references.

Some key facts about the TM regulatory requirements:

• TMs are not subject to approval and license by HSA for their import, manufacture, and sale.
• HSA prohibits the addition of medicinal ingredients such as steroids in TMs. 
• HSA also sets strict limits on the toxic heavy metals in TM products.

Cosmetic products

A cosmetic product is defined as any substance or preparation intended to be placed in contact with the outside of the human body. Cosmetic products are usually used for:

• Cleaning body parts;
• Perfuming body parts;
• Enhancing appearance;
• Improving body odor;
• Protecting skin; and
• Keep skin in good condition.

Injections and eye drops, as well as products for treatment (e.g., anti-acne creams), are not included in the definition of cosmetics and are considered therapeutic products.

Some key facts about the cosmetic product regulatory requirements:

• Before selling a cosmetic product in Singapore, you will have to submit a cosmetic product notification.
• In Singapore, cosmetic product manufacturers do not need to apply for a special permit. However, manufacturers can apply for a Good Manufacturing Practice (GMP) certificate to facilitate the export of their cosmetic products.
• Singapore’s regulations on the quality and safety of cosmetic products are similar to the requirements for these items in the European Union.

Tobacco products

In Singapore, tobacco products are controlled under the Tobacco (Control of Advertisements and Sale) Act, which aims to reduce smoking prevalence.

Some key facts about the tobacco product regulatory requirements:

• A valid tobacco license is required before you can import, wholesale, distribute, or retail tobacco products in Singapore.
• Imitations of tobacco products, such as electronic cigarettes, are prohibited by law.
• Chewing tobacco is also prohibited in Singapore.
• From 1 July 2020, all tobacco products (excluding harmful and imitated ones) imported, sold, offered for sale, or distributed in Singapore must meet standard packaging (SP) specifications.
• Under the Tobacco (Control of Advertisements and Sale) Act, anyone caught selling tobacco products to persons below the minimum legal age is liable, on conviction in Court, to a maximum fine of up to $5,000 for the first offense and up to $10,000 for the second or subsequent offenses.
• Outlets found selling tobacco products to minors in school uniform or those under 12 years of age will have their tobacco retailer license revoked, even at the first offense.

Tobacco licenses that you may require:

• • Tobacco retail license – for opening a retail store selling tobacco products. This kind of license is issued only to certain outlets. Licenses are not transferable between outlets.
  • Import and wholesale license – for importing and wholesaling tobacco products in Singapore. To obtain this license, companies must comply with the rules and regulations of the Tobacco Act.

Cell, tissue, and gene therapy products

Cell, tissue, or gene therapy products (CTGTPs) are healthcare products intended for use in humans for therapeutic, preventive, palliative, or diagnostic purposes. These products can contain any of the following:

• living or non-living human cells or tissues;
• living animal cells or tissues; and
• recombinant nucleic acid.

These products are not considered CTGTPs:

• Recombinant vaccines for prevention purposes as these are usually considered as therapeutic products;
• In-vitro diagnostic products;
• Minimally manipulated bone marrow, peripheral or umbilical cord, or placental blood from humans and intended for homologous use;
• Cells and tissues obtained from minimally manipulated patients and replanted for homologous use into the same patient during the same surgical procedure;
• Minimally manipulated organs and tissues intended for transplant;
• Reproductive cells (sperm, eggs) and embryos intended for assisted reproduction; and
• Whole blood of any component of blood that is minimally manipulated and intended to treat blood loss or blood disorders.

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