Q&A – Medical Device/IVD/CDx Product Registration

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What are the qualifications for Innovation Approval?


NMPA (CFDA) published “Special Review and Approval Procedure for Innovative Medical Devices” on November 5, 2018. The guideline has been implemented on December 1, 2018. Qualifications for Innovation Approval:

1. Class II / Class III Medical Device with significant clinical application value,
2. Own valid invention patents,
3. Have China PTO coverage,
4. Complete the preliminary study on prototype with traceable data, and an authorized in-country legal entity.

Can renewal be processed if registration certificate is lost?


No. Registration certificate is a necessary file in renewals. Original certificate must be submitted to NMPA once the renewal is approved. Applicants must request reissue if the certificate is lost.

Is change of interior packing allowed in registration renewal?


No. Renewal means no changes on the registered products. Unless mandatory standards are changed, any changes are not allowed in renewal.

What are the steps in the renewal process?


Here are the key steps: (1) prepare renewal dossier (2) Type testing (3) submission and NMPA review (4) NMPA issue supplement notice (5) submit supplement documents (6) final review (7) approval

What information is required for renewal application? 


Mandatory documents from the manufacturer for no-change renewal:
(1) Copy of original CFDA (NMPA) certificate with annex if there is any, original product standard (with CFDA stamp)
(2) Type testing report

Does type testing in China need to be repeated in renewal process?


Type testing is required for renewal when the Chinese standards mandatory for the product has changed/updated since the initial registration.

What types of changes does the NMPA allow to be included in a modification registration?


There are two types of modification registration with NMPA in China.
1. First-level modification (do not need reviewer review or approval)
·       Registrant name change
·       Registrant address change
·       Manufacturing site address change for domestic medical device
·       Legal agent change
·       Legal agent address change
2. Second-level modification (need reviewer review and approval)
·       Product name change
·       Product technical requirements change
·       Model/specification change
·       Components and structure change
·       Intended use/indication change
·       Manufacturing site address change for imported medical device
·       Other changes that may lead to change of license contents
·       Other changes