Welcome to EconCare Technology Pty Ltd official website!
Inquiry Form | Compliance Hotline
Hotline:
+86-010-84466226

FAQ for Foreign Manufacturers | China Compliance Home / Resources / FAQ for Foreign Manufacturers

My product is Class I (low-risk) overseas. Does it only require filing in China as well?
Release time:2026-07-14      Number of clicks:30

Answer: Not necessarily. China’s medical device classification criteria are more stringent than those of many other countries. Many products classified as Class I in Europe and the United States may be categorized as Class II or even Class III in China. We recommend submitting an application for Chinese classification determination at the early project initiation stage to prevent incorrect registration routes, approval delays, or compliance risks caused by misclassification.

Last: NO！

Return

EconCare Technology Pty Ltd

Add: Room 201, Huaguan Building, No.46 Xinnan Road, Building 1, Southwest of the Great Wall Roundabout, Jingcheng Road, Miyun District, Beijing

Tel: +86-010-84466226

Mobile
Wechat

Copyright © 2026 All rights reserved: EconCare Technology Pty Ltd | 京ICP备2026039953号-1 | RSS | Sitemap | Disclaimer

Link: