Would the proposed TFDA submission treat the product as a new medical device or a change to an existing registered device?

Would the proposed TFDA submission treat the product as a new medical device or a change to an existing registered device?

Taiwan's Medical Devices Act, announced on 15 January 2020, states in Article 26: “Alteration may only be made to any of the particulars of registration and market approval or listing pertaining to any medical device designated by the central competent authority after approval of the central competent authority is obtained.”

The company does not say whether any submission would be treated as a new device or as a change. The company sets out its position under two bodies of law only, and neither of them is the law there.

Under United States law, NF Technical Products Inc. 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, C-POLAR Technologies, Inc. classifies the same filter as neither a biocidal product nor a treated article. Each statement records that it addresses that one question only. No authority has approved, registered, endorsed or cleared the filter; the company classifies its own article.

What an authority requires of a product placed on its market is decided under its own rules, by the party that places it there. Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format.

Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 1.3 and 3.7, issued by NF Technical Products Inc.; Statement of Regulatory Status for the NanoFlashing™ Air Filter, sections 1.3 and 3.7, C-POLAR Technologies, Inc., 11 September 2026; C-POLAR — Terms of Use, section 6, https://cpolar.tech/terms/; Medical Devices Act (Taiwan), Article 26, announced 15 January 2020, English translation by the Ministry of Justice, read 20 September 2026, https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030106.

Reviewed on 21 September 2026.