Would a South African health-product claim bring the finished product within SAHPRA's remit?
Last reviewed: .
Would a South African health-product claim bring the finished product within SAHPRA's remit?
The company publishes no position under South African law, and 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.
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. Whether a claim someone else proposes to make brings a finished product within a national authority's remit is a question for that authority and for the party making the claim.
Source: 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; NanoFlashing™ Air Filter label.
Reviewed on .
Sources
- Statement of Classification for the NanoFlashing™ Air Filter, section 3.7, issued by NF Technical Products Inc.
- Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 3.7, C-POLAR Technologies, Inc., 11 September 2026
- NanoFlashing™ Air Filter label, About this product
- C-POLAR — Terms of Use, section 6