For the past 2 years, many of our customers have been importing supplies for both personal and commercial usage to fight the COVID-19 pandemic together.
Hence, we thought we should post this little update from HSA with regards to new (or rather, reinstated) regulations from 1 September 2022:
The Exemption Order 2020 will be revoked on 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 is a small provision which allows for personal usage/import, which is, as of 14 August 2022:
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
That said, please check out the HSA website at https://www.hsa.gov.sg/announcements/regulatory-updates/import-of-hand-sanitisers-masks-thermometers-and-protective-gear for more information on the revised guidelines.