2023 China NMPA (CFDA) Blue Book:

Revised Medical Device & IVD Regulations

Your guide to unprecedented change in registration, renewal and post-market compliance of medical devices, IVDs, CDx and combnation products in China.

Please review our qualifications for a complimentary 2023 Bluebook copy:

Completed survey, with accurate contact information
Manufacturers section filled out correctly

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Basic Information

First Name

Last Name

Company

Title

Phone

Country

Business Information

Please indicate the type of your business:

Manufacturing Contract Manufacturing Consulting Distribution Legal CRO Association Other

Please indicate the types of product you have:

Active Device Passive Device IVD SaMD CDx Combination Product Cosmetic AI Others

Does your company have product registered in China?

Yes No

Product Indications

If yes, please tell us how many NMPA (CFDA) certificate you have for each classification:

Class I

Class II

Class III

Please check all the types of services you will need within the next 12 months:

China Market Assessment Registration Strategy Fast-track Approval New Registration Local Type Testing Clinical Pathway Evaluation CER Clinical Trial Overseas Inspection Post Market Compliance AE Recall None of these

Other service you need:

What are the top challenges for China Market Entry?

What are your top needs for your business success in China?

How do you keep yourself updated with NMPA (CFDA) knowledge and reform?

What types of information you will like to receive regarding NMPA (CFDA)?

Any webinar training topics that you would like to see?