Understand the requirements to import, manufacture or sell traditional medicines in Singapore.
In the local context, traditional medicines (TM) refer to Malay and Indian traditional medicinal products. They are finished products containing ingredients with uses documented in relevant TM references.
Food and supplements of food nature come under the purview of the Singapore Food Agency (SFA). View the interactive Food-Health Product Classification Tree1517 KB for more information.
Answer a few questions in our self-help tool to find out if your product is considered a complementary health product (e.g. Chinese Proprietary Medicine, Health Supplement, Traditional Medicine) in Singapore.
You can also get a print-out of your product classification outcome from the tool.Let's go
Want to know more about CHP product classification? Click here for our FAQ.
Traditional medicines are not subject to approvals and licensing by HSA for their importation, manufacture and sale. HSA prohibits the addition of medicinal ingredients such as steroids in TM. HSA also sets strict limits on toxic heavy metals in these products. Dealers (importers, manufacturers, wholesale dealers and sellers) have the obligation to ensure that their products are not harmful or unsafe, and that they conform with the following guidelines before supplying traditional medicines into Singapore.
Dealers may voluntarily notify HSA of their traditional medicines supplied in Singapore. Companies must provide HSA with the relevant documents to demonstrate that their products meet the necessary safety and quality standards. Click here for more information.
As a dealer of traditional medicines, you must ensure your products conform with our safety and quality standards.
Traditional medicines that are imported or sold must not contain the following:
Your product must not exceed the following heavy metal limits:
Your product must not exceed the following microbial limits:
Total aerobic microbial count
Not more than 105 CFU per g or ml
Yeast and mould count
Not more than 5 x 102 CFU per g or ml
Escherichia coli, Salmonellae and Staphylococcus aureus
Absent in 1g or ml
Notwithstanding the limits stated above, it is the obligation of the dealers and sellers to ensure that the microbial content and heavy metals of the product is appropriate and safe when used according to the recommended conditions of use and target users. Dealers are encouraged to comply to the ASEAN Guidelines on the Limits of Contaminants for microbial limits. The applicable guidelines is posted at the ASEAN website (click on "POLICY & GUIDELINES" under "Key Documents & Publications" to expand the section and refer to point 11).
Oral liquid CHPs must not exceed the following diethylene glycol and ethylene glycol limits:
Your product needs to achieve acceptable standards of quality in terms of:
Please refer to the following guidelines for more information:
Your product label should be prominent and conspicuous. Its information in English should be adequate and truthful. The label should contain the following:
Please refer to the labelling standards guidelines288 KB for more information.
Please note that you are also not allowed to claim or indirectly suggest that the product will prevent, alleviate or cure any of the following conditions:
Dealers must ensure that all health claims and information associated with the products are sufficiently supported and submitted to HSA as and when required. Otherwise, all unsubstantiated health claims and information will be considered misleading and must be removed from the product materials. Please refer to the Guidelines for Claims and Claim substantiation325 KB, as well as the List of Health Claims259 KB for more information.
You will require a valid permit from us before publishing any medical advertisements or conducting any sales promotion activities directed to the general public.
Refer to our advertisements and promotions guidelines for more information on what is required before you run any advertisements and promotions for your products.
Some importing countries may require a certificate to show that the product is currently sold and distributed in Singapore.
As such, local exporters may apply for a FSC from the Health Sciences Authority.
Each FSC is specific to one product and allows the inclusion of up to five importing countries. Information in the FSC includes:
Regulatory overview
Voluntary Notification of HS and TM
List of Notified HS and TM
Advertisements and promotions
Report adverse events
Traditional medicinal materials
International collaboration
CHP Classification Tool