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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 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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Data is being organized. Please stay tuned for updates.

Data is being organized. Please stay tuned for updates.

2026-07-20
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Data is being organized. Please stay tuned for updates.

Data is being organized. Please stay tuned for updates.

2026-07-20
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EconCare Technology Pty Ltd

Because Every Medical Product Deserves a Safe Journey to Patients

EconCare Technology Pty Ltd

+86-010-84466226

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Resources | EconCare Technology Home / Resources

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

Is clinical trial in China mandatory for my product?

Is domestic manufacturing in China compulsory for imported medical devices?

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

Data is being organized. Please stay tuned for updates.

Data is being organized. Please stay tuned for updates.

Resources

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

14

Is clinical trial in China mandatory for my product?

14

Is domestic manufacturing in China compulsory for imported medical devices?

14

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

14

EconCare Technology Pty Ltd Because Every Medical Product Deserves a Safe Journey to Patients

EconCare Technology Pty Ltd

+86-010-84466226

Home

About Us

Services

Resources

Contact

Resources | EconCare Technology Home / Resources

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

Is clinical trial in China mandatory for my product?

Is domestic manufacturing in China compulsory for imported medical devices?

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

Data is being organized. Please stay tuned for updates.

Data is being organized. Please stay tuned for updates.

Resources

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

14

Is clinical trial in China mandatory for my product?

14

Is domestic manufacturing in China compulsory for imported medical devices?

14

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

14

EconCare Technology Pty Ltd

Because Every Medical Product Deserves a Safe Journey to Patients