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Health Sciences Authority
Regulatory Updates

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

Audiences

Consumer

Industry member

Product type

Medical devices

Therapeutic Products

14 February 2020

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Hand Sanitisers
Hand sanitisers do NOT need approval from the Health Sciences Authority (HSA) before they are brought into Singapore for sale. To obtain more information on the established active ingredients and labelling of products such as hygienic hand rubs or sanitisers, please click here.

Masks, Thermometers and Protective Gear for Medical Professionals

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UPDATE:

The Exemption Order 2020 has been revoked with effect from 1 September 2022.

From 1 September 2022, all standard regulatory controls for the following medical devices will apply.

  • Surgical masks, Medical masks;

  • Particulate respirators e.g. surgical N95 masks;

  • Thermometers for measuring human body temperature; and

  • Any protective gear for medical professionals e.g. isolation gowns and gloves

For an overall understanding of processes and requirements for product registration and licensing of dealers, you may refer to our Quick Guide available at http://www.hsa.gov.sg/medical-devices/regulatory-overview

Please note that all stocks of the medical devices imported under the Exemption Order 2020 must be supplied out to retail level by 31 August 2022. You are to cease all import or wholesale supply of these medical devices from 1 September 2022, unless your company holds valid Importer's and/or Wholesaler's licence from HSA and have registered the thermometers you have imported.

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, Medical masks; (with good filtration efficiency)

  • 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:

Flowchart guiding importers on hand sanitiser classification and regulatory requirements

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

In line with mask guidelines announced by the Ministry of Health (MOH) on 18 May 2021, all medical and surgical masks imported via the Exemption Order 2020 shall fulfill the requirement of 95% bacterial filtration efficiency (BFE). Therefore, applicants who are importing medical or surgical mask are required to submit a copy of Bacterial Filtration Efficacy (BFE) test report or certificate relevant to the masks being imported from the manufacturer as part of the supporting document in the Notification Form to HSA. Note: If the test report or certificate does not reflect the brand of medical and surgical masks to be imported, a written explanation from the overseas mask manufacture shall be provided to justify the applicability of the certificate or report to the mask being imported.

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 template

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:

Flowchart guiding importers on mask and protective gear classification requirements

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

For more information on masks, please refer to https://www.hsa.gov.sg/announcements/what-you-need-to-know-about-masks/

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