CFDA 
Regulatory
Affairs

The product registration requirements and process in China can be really different from the US and EU. MedGogo has successfully obtained hundreds of China NMPA certificates for our client. Our integrated regulatory, technical, and clinical team can help you prepare required documents, give on-site type testing support, provide full CRO service to accelerate your process for registering your product in China.

NMPA Renewal application must be submitted 6 months prior to the certificate expiration date for no change renewal. NMPA is very strict about their rules and regulations. We are a certified CFDA legal agent in China and have helped many clients with their renewals, modifications, or new applications.

Three fast-track Channels have been established by NMPA to encourage innovation and deal with unmet medical needs: Innovation Approval, Priority Review, and Emergency Approval.

Innovative Device Status is established by NMPA to encourage innovation and bring innovative technology to China: Being granted status can significantly shorten the time for market introduction. If the “Innovation Device Status” is granted (which does not mean “approval”), the device will be allocated ‘front-of-queue’ priority throughout the registration process. The granted priority affects the classification determination, pre-clinical testing, QMS auditing, and CFDA reviewing/approving processes. Meanwhile, a specially-assigned NMPA officer would check in and provide needed guidance throughout the whole expedited process.

For Priority Review, applicants have to meet one of the following scenarios:

1. Treat rare diseases with significant clinical application value,

2. Diagnose or treat malignant tumors with significant clinical application value,

3. Diagnose or treat geriatric diseases, which no currently have effective diagnosis or treatment

4. Be intended for pediatric diseases with significant clinical application value,

5. Be intended for unmet medical needs, which currently have no effective diagnosis or treatment, or

6. Be listed in National Science and Technology Major Projects or National Key R & D Plans

 

For Emergency Approval, have to meet one of the following scenarios:

• Be intended for public health crises, which currently have no effective product, or

• Be intended for unmet medical needs