Would a Singapore medical claim require an HSA-related assessment?

Would a Singapore medical claim require an HSA-related assessment?

The rule is Singapore's Health Products Act 2007, and the company publishes no position under Singapore law.

Section 15(1) of the Act states: “Except in such cases as may be prescribed, a person must not supply any health product unless the health product is a registered health product.” Section 4(1) states that, except as provided in Part 14, the Act “applies only in relation to the categories of health products that are specified and described in the first and second columns of the First Schedule to the extent prescribed in the third column thereof.” The first category in the First Schedule is the medical device, described as “any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purposes of” the purposes it lists, the first of which is “diagnosis, prevention, monitoring, treatment or alleviation of disease”. The company sets out its position under United States law and under Regulation (EU) No 528/2012, and under no other country's law.

Under United States law the company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a). Under Regulation (EU) No 528/2012 the company classifies the filter as neither a biocidal product nor a treated article. No authority has approved, registered, cleared or endorsed the filter. The company classifies its own article. The Terms of Use state that, as of their effective date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications, and that they do not describe finished products currently available from C-POLAR for those uses. The label for the NanoFlashing™ Air Filter states that the filter is not a medical device and is not intended to diagnose, treat, cure or prevent disease. Whether a claim someone else proposes to make brings a product within a national health authority's remit is a question for that authority and for the party making the claim.

Source: Health Products Act 2007 (Singapore), sections 4 and 15 and First Schedule, Singapore Statutes Online, current version, read 20 September 2026, https://sso.agc.gov.sg/Act/HPA2007; Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1, issued by NF Technical Products Inc.; Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 3.7, 5.1 and 5.2, C-POLAR Technologies, Inc., 11 September 2026; C-POLAR — Terms of Use, section 4, https://cpolar.tech/terms/; NanoFlashing™ Air Filter label.

Reviewed on 21 September 2026.