Would a Malaysian medical application require a local authorised representative and a product-specific route?
Last reviewed: .
Would a Malaysian medical application require a local authorised representative and a product-specific route?
The duties of an importer, a distributor or a downstream user sit with that party, and the company publishes no file for them.
The company sets out its position under United States law and under Regulation (EU) No 528/2012, and under no other country's law. Whether a country requires a local representative, and what route a product takes there, is a question for that country's law and for the party that would place the product on that market. 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.
Source: C-POLAR — Terms of Use, sections 5 and 6, https://cpolar.tech/terms/; 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. A question about a particular product or market can be sent to [email protected] or +1 604 630 6830.
Reviewed on .
Sources
- C-POLAR — Terms of Use, sections 4, 5 and 6
- 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