FAQ for Foreign Manufacturers | China Compliance

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?

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...

2026-07-14
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Is clinical trial in China mandatory for my product?

Answer: It is not a mandatory requirement. NMPA offers multiple clinical evaluation pathways:Catalogue of Devices Exempt from Clinical Evaluation: If your product is listed in the ...

2026-07-14
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Is domestic manufacturing in China compulsory for imported medical devices?

Answer: It is not mandatory, though relevant policies are encouraging this practice. Per the latest NMPA Announcement issued in 2025, holders of imported medical device registratio...

2026-07-14
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My product consists of both pharmaceutical and device components (e.g., pre-filled syringes). What registration pathway should I follow?

Answer: This is a combined drug-device product, subject to the most complex regulatory procedures. The NMPA Center for Standardization will first conduct attribute classification:&...

2026-07-14
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