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2024 China NMPA Bluebook is here:

Registration Certificates Become Paperless

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The electronic registration certificate for medical devices will be fully implemented, starting on November 1, 2022.

After October 2020, when the electronic certificates for domestic Class III, imported Class II and III devices became available on a pilot basis, 14,000 electronic certificates and 3,500 modification registration have been issued.

Notice of Electronic Registration Certificate

The notice regulates that:

  • The electronic certificates for initial and modification registrations will be apply to devices approved after November 1, 2022
  • The electronic certificate has the same legal effect as the paper certificate. The electronic certificate has functions such as instant delivery, SMS reminder, license authorization, code scanning query, online verification, and network-wide sharing.
  • The electronic certificate does not include product technical requirements, IFU and other accessories.
  • Enterprises must first register in the online service hall of the NMPA and have real-name authentication

View our guideline on Electronic Submission System (rRPS).

If you have the following questions, please email info@ChinaMedDevice.com

  • What is a CA certificate? How does one apply for a CA certificate?
  • What are the filing review requirements for Chinese submissions?
  • What are the RPS-ToC catalog and requirements?
  • How RPS catalog structure looks like?

About China Med Device, LLC

China Med Device, LLC (chinameddevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.

Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.