Relying on the support of professional teams in China, integrating the over 20 years’ CFDA working experience and the start-up company consulting experience of the core team, we focus on providing the regulation affairs related consulting services of medical devices in China and overseas.

We would like to provide a one-set service for medical device companies, which is the product registration oriented, with the quality system construction as the core and the clinical researches as the support.

The one-set service is consisting of:

• Strategy designing for medical device registration
• Products’ definition and classification
• Registration documents’ compilation and instruction(composing technical specification of products included)
• Sample delivery and tests
• Clinical experiments for products‘ registration
• Communication with the product technical review team (Center for Medical Device Evaluation, CMDE)

We provide first-class service with reasonable price. The charge rate varies according to the product and item.

Contact Us

If you have any question about our Medical Device Registration service, please feel free to contact us:

Email:   l.yao@ccicmarseille.com

Phone:  +33 (0)4 91 72 73 70