Guidance on the Import of Hand Sanitisers, Masks, Thermometers and Protective Gear to Singapore
From Singapore Health Sciences Authority
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
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.
Masks, Thermometers and Protective Gear for Medical Professionals
There has been a surge in demand for certain medical devices during this COVID-19 period. To facilitate the import to meet the increase in local demand, since 31 Jan 2020, importers of the following medical devices do not require an importer’s licence from HSA:
- 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:
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.
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:
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