Guidance on the Import of Hand Sanitisers, Masks, Thermometers and Protective Gear to Singapore

Regulatory overview of topical antiseptics
Understand the requirements to import, manufacture or sell topical antiseptics in Singapore.

What are topical antiseptics

Topical antiseptics refer to products that are placed in contact with external parts of the human body or mucosal membranes of the oral and nasal cavity to kill microorganism, or to inhibit or prevent the growth of microorganism, with the primary intent to limit or prevent infection.

Topical antiseptics may include products such as:

hygienic hand rub or sanitizers
wound disinfectants
pre-surgical skin disinfectants
Topical antiseptics do not include products with the primary intent for cosmetic function such as cleansing purpose (for example skin cleanser, hand wash). Refer to our cosmetic products section for more information on cosmetic products.

Regulatory requirements of topical antiseptics

We regulate topical antiseptics in Singapore under the following legislation:

Medicines Act (Chapter 176) and its subsidiary legislation especially:
Medicines (Traditional Medicines, Homeopathic Medicines and Other Substances) (Exemption) Order
Medicines (Prohibition of Sale & Supply) Order
Medicines (Medical Advertisements) Regulations
Medicines (Labelling) Regulations
Medicines (Advertisement and Sale) Act (Chapter 177)
Topical antiseptics are not subject to approval and licensing by HSA for their importation, manufacture and sales in Singapore.

Dealers (manufacturers, importers, wholesale dealers and sellers) must ensure that their products are not harmful or unsafe, and that they conform to the following guidelines and applicable quality standards before supplying topical antiseptics in Singapore.

• Surgical masks;
• Particulate respirators e.g. N95 masks;
• Thermometers for measuring human body temperature; and
• Any protective gear for medical professionals e.g. isolation gowns and gloves

(1) Import for Commercial and/or other purposes (not for personal use):
If you are importing these medical devices for commercial or other purposes (e.g. workplace use, donation), please submit a notification to HSA using the form in the URL below:

URL: https://go.gov.sg/HSAExemptionOrderNotification

Importers can use the template provided below to maintain their sales or distribution records. Where necessary (e.g. recall of certain brands of thermometers), HSA may require these records to be submitted for our review.

2020 Distribution records template15 KB

These measures are to minimise the risk of sub-standard products being brought into Singapore.

(2) Import for Personal Use (for use by an individual and/or family members):
If you are importing the following medical devices for personal use in quantities within the limits indicated below, you do not need to submit any notification to HSA:

• Surgical masks: 3 boxes (3 x 50 pieces) per person
• Particulate Respirators: 3 boxes (3 x 20 pieces) per person
• Thermometers: 2 units per person

If the imported quantity exceeds the above limits, please submit a notification to HSA using the form in the URL below: