Exclusive Content
Can I export used or refurbished medical devices to China?
Can you export used or refurbished medical devices to China? The short answer is: generally no, with very limited exceptions. China’s Medical Device S
What documents are required for China NMPA medical device registration?
What documents are required for China NMPA medical device registration? The answer is a dossier of 14 core documents that vary by device classificatio
How much does China medical device registration cost?
China medical device registration costs range from CNY 150,000 to CNY 5,000,000 (USD 21,000 to USD 700,000) total per device, depending on classificat
What is the difference between Class I, II, and III medical devices in China?
China's medical device classification system, overseen by the National Medical Products Administration (国家药品监督管理局, NMPA, Guójiā Yàopǐn Jiāndū Guǎnlǐ J
Can foreign medical device companies register directly in China?
Foreign medical device companies cannot register their products directly with China’s National Medical Products Administration (NMPA, 国家药品监督管理局, Guóji
Core Document Requirements for All NMPA Registrations
What documents are required for China NMPA medical device registration? The answer is a dossier of 14 core documents that vary by device classificatio