Notice on Medical Devices, Medicinal Products, Cosmetic, Health Supplement, Chinese Proprietary Medicines (CPM), Traditional Medicines
Medical Devices

Since 1 January 2012, under the Health Products Act and the Health Products (Medical Devices) Regulations, all medical devices, other than those exempted by the Regulations, are required to be registered with the Health Sciences Authority (HSA), prior to its placement on the Singapore market for sale. In addition, all dealers of medical devices, including the manufacturers, importers and wholesalers are required to be licensed by the HSA.

For more information, please visit HSA’s website at http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Medical_Devices/Overview.html


Medicinal Products

Medicinal products to be imported or sold in Singapore are regulated by the Health Products Regulation Group, Health Sciences Authority (HSA). A medicinal product has to be registered with HSA and requires a product licence in order to be imported, sold and/or supplied in Singapore (Medicines Act, Cap. 176), unless otherwise exempted under the law. 

There are controls on who may lawfully supply medicinal products depending on the types of medicinal products. In general, registered medicinal products are classified into three categories: Prescription Only Medicine (POM), Pharmacy Only Medicine (P) or General Sale List (GSL). POMs can only be supplied by a doctor or a pharmacist according to a prescription by a doctor. P medicines can be supplied by or under the supervision of a pharmacist without a doctor’s prescription, while GSL medicines can be supplied through any retailer. Information on the classification category of currently registered medicinal products in Singapore is available on the online Infosearch-Medicinal Products function of the HSA website.  

Before conducting any activities relating to medicinal products, you are advised to be familiar with the relevant legislations governing medicinal products in Singapore, which are available on the HSA website:
• Medicines Act and its Regulations
• Medicines (Advertisement and Sale) Act
• Sale of Drugs Act and its Regulations
• Poisons Act and Rules

More information on the regulatory controls of medicinal products in Singapore can be found on the HSA website. If you are unsure of the regulatory controls pertaining to the medicinal products or activities that you wish to conduct in Singapore, you are advised to consult the HSA before conducting such activities (click here for the product enquiry form).

Advertisements and sale promotion
Under the Medicines (Medical Advertisement) Regulations, advertisements and sales promotions of medicinal products in all forms of media, including the internet, are subject to pre-publish permit requirements. 

Advertisements and sales promotion of Prescription Only Medicines (POM) directed to the public are strictly not allowed. 

For more information, please refer to our website for an overview on medical advertisements and sales promotion (click here), or contact the Medical Advertisement Unit at hsa_ma@hsa.gov.sg. 


Cosmetic

Cosmetic products are currently not subjected to Health Sciences Authority’s (HSA) approval before they are placed in the market.  They are also not assessed or approved by HSA for their effectiveness before being sold.  Under current regulations, companies or individuals who manufacture, import and sell cosmetic products are directly responsible for the safety of the products and required to notify Health Sciences Authority (HSA) before placing their cosmetic products for local sales/supplies.
 
For more information on the regulatory control of cosmetic products, please click on this link:
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Cosmetic_Products/Overview.html


Health Supplement

Currently, health supplements are not subject to pre-marketing approval by the Health Sciences Authority (HSA).  Dealers are responsible for the safety and quality of their products and must ensure that their products comply with the requirements stipulated in the guidelines on health supplements set out by the HSA.

More information on the regulation of Health Supplements can be found below on the following web links:-
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Complementary_Health_Products/Health_Supplements.html

Chinese Proprietary Medicines (CPM)

Currently, dealers of Chinese Proprietary Medicines (CPM) whose CPM are presented in finished dosage forms (e.g. tablets, capsules and granules) will require the relevant licences and product approvals from the Health Sciences Authority (HSA) prior to the import, wholesale, manufacture and assembly of CPM. 

For further details on the control of CPM, please refer to the HSA’s website at:
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Complementary_Health_Products/Chinese_Proprietary_Medicines.html

Traditional Medicines

Please be informed that Traditional Medicines are currently not subject to pre-marketing approval and licensing by the Health Sciences Authority (HSA) for their import, manufacture and sale in Singapore.  It is however, the responsibility of the dealer to ensure that the product that the company is dealing with fulfils the requirements stated on the HSA's website: 

http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Complementary_Health_Products/Traditional_Medicines_Homoeopathic_Medicines.html




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