Imported Medical Devices CFDA Registered Items Alteration Guideline

On March 27^th 2017, China Food and Drug Administration (CFDA) issued ‘Imported Medical Device Alteration Registration Approval Service Guideline’. This guideline standardized the imported medical device registered Items alteration.

Guideline Applicable Objects
The registered imported class II and III medical devices:

Alteration registration--- The product have substantial change on the design, raw materials, manufacturing technique, applicable scope, application method and etc. These change may affect the product safety and effectiveness. The applicants should apply for the alteration registration process in the original registration department.
Alteration recording--- If the product have the unsubstantial change and the change will not influence the product safety and effectiveness, the applicants could record the change in the original registration department.

Application submission Method

Submit the application to the China Food and Drug Administration (CFDA) administration service window.
Mail the application to the China Food and Drug Administration (CFDA) administration service center.

Duration
According to the CFDA regulation issued on April 6th 2017 about ‘Adjust Some Medical Device Administration Approval Process’s Decisions', the Center for Medical Device Evaluation. CFDA will represent CFDA to give imported medical devices CFDA registered items alteration approval. This regulation can help the imported manufactures save time for obtaining the alteration approval.
Alteration registration:

Imported Class II medical device: 93 business days
Imported Class III medical device: 123 business days

Alteration recording:

Imported Class II medical device & Imported Class III medical device: The recording application will be approved by the China Food and Drug Administration (CFDA) immediately, but the administrative licenses will be sent to the applicants within ten business days.

* If you have any comments or questions, please contact us at md@cirs-group.com.

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