Would the proposed Japanese medical-device route require a marketing authorisation holder distinct from the importing distributor?
Last reviewed: .
Would the proposed Japanese medical-device route require a marketing authorisation holder distinct from the importing distributor?
Who must hold an authorisation there is settled in that market, and the company publishes no position under Japanese law.
The company sets out its position under United States law and under Regulation (EU) No 528/2012, and under no other country's law. It publishes no position under the law of Japan or of Korea. Every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830.
Source: Statement of Classification for the NanoFlashing™ Air Filter, section 3.7, NF Technical Products Inc.; Statement of Regulatory Status for the NanoFlashing™ Air Filter, section 5.2, C-POLAR Technologies, Inc., 11 September 2026; C-POLAR — Terms of Use (https://cpolar.tech/terms/) and C-POLAR — Contact (https://cpolar.tech/contact/).
Reviewed on .
Sources
- Statement of Classification for the NanoFlashing™ Air Filter, NF Technical Products Inc.
- Statement of Regulatory Status for the NanoFlashing™ Air Filter, C-POLAR Technologies, Inc., 11 September 2026
- C-POLAR — Terms of Use
- C-POLAR — Contact