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In brief

A company was charged with manufacturing more than 430,000 three-ply surgical masks between October 2020 and April 2021 without a valid manufacturer’s licence.


Key takeaways

  • Section 12 of the Health Products Act (HPA) prohibits anyone from manufacturing any health product unless they (i) hold a valid manufacturer’s licence; and (ii) carry out said manufacture in accordance with the conditions of the licence. Health products are, in turn, widely defined so as to include medical devices such as surgical masks.
  • Anyone found to have manufactured a health product without a valid manufacturer’s licence may be imprisoned for up to two years, and/or fined up to SGD 50,000 upon conviction. The maximum fine may be doubled if the offender is a corporation.

Background

A company was charged with manufacturing more than 430,000 three-ply surgical masks between October 2020 and April 2021 without a valid manufacturer’s licence.

The company, which indicated on its website that it locally manufactures “medical grade surgical masks”, is set to plead guilty to the charges this month.

A list of locally manufactured surgical masks that are licensed by the Health Sciences Authority may be found here.

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Author

Andy Leck is the managing principal of Baker McKenzie.Wong & Leow. Mr. Leck is recognised by the world’s leading industry and legal publications as a leader in his field. Asian Legal Business notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice”. Alongside his current role as managing principal, Mr. Leck has held several leadership positions in the Firm and externally as a leading IP practitioner. He currently serves on the International Trademark Association's Board of Directors and is a member of the Singapore Copyright Tribunal.

Author

Ren Jun is an associate principal of Baker & McKenzie.Wong & Leow. Ren Jun extensively represents local and international intellectual property-intensive clients in both contentious and non-contentious IP matters, such as anti-counterfeiting; civil and criminal litigation; commercial issues; regulatory clearance; and advertising laws. Ren Jun also advises on a wide range of issues relating to the healthcare industries. These include regulatory compliance in respect of drugs, medical devices, clinical trials, health supplements and cosmetics; product liability and recall; and anti-corruption. Ren Jun is currently a member of the Firm's Asia Pacific Healthcare ASEAN Economic Community; Product Liability and Regulatory Sub-Committees.

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