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My product is Class I (low-risk) overseas. Does it only require filing in China as well?

Answer: Not necessarily. China’s medical device classificati...

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

Answer: It is not a mandatory requirement. NMPA offers multi...

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

Answer: It is not mandatory, though relevant policies are en...

14
2026-07
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 t...

14
2026-07

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