중국 NMPA: 의료기기 등록 경로

How does China register devices? Class I is filed, Class II and Class III are registered, and for makers abroad, NMPA handles both. Plus, a revised GMP starts November 1. For imported devices in Class II or III, NMPA runs the technical review. By rule, Class II gets 60 working days, Class III gets 90. A decision follows within 20 working days. If NMPA asks for more, your reply time doesn't count, and reviewing it can take up to 60 more working days. An overseas maker works through a China-based agent and shows the device is authorized for sale at home, unless it is innovative and not yet sold abroad. The dossier must be in Chinese, and so must labels and instructions. One more date. On November 1, 2026, NMPA's revised device GMP replaces the 2014 version. It covers registrants, filers and contract manufacturers, from design to after-sales service. Start with three things. One: confirm your class in China's catalogue. Two: check your quality system against the revised GMP. Three: apply to renew at least six months before your certificate expires. Classify early, then file in Chinese. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.