Change in Chinese registration

Change registration of medical device takes longer from preparation, submission to approval in China. It is clear after submission or approval significant change must be considered in next registration and non-significant change flows automatically in current medical device registered.

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How to react if product change happens during the preparation of Chinese technical documentation prior to submission?

 

Here below we analysis the critical impact point of product change: Product technical requirement + type testing and submission dossier.

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Scenario 1

Significant change yes

PTR + Type Testing yes

Technical documentation yes

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This is most challenging changes if manufacturer should consider the efforts to include it in planned or running type testing.

If the significant changes triggers more than half year delay of submission including testing and technical documentation, either put significant changes in next registration or start a parallel initial registration.

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Scenario 2

 

Significant change yes

PTR + Type Testing yes

Technical documentation no

 

This scenario is typical for change of critical electronical component, specifications in PTR, obligatory Chinese standards, depending on the stage of type testing, manufacturer might repeat testing units, revise testing report and update PTR.

As above If the significant changes triggers more than half year delay of testing, either put significant changes in next registration or start a parallel initial registration

 

Scenario 3

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Significant change yes

PTR + Type Testing no

Technical documentation no

 

This might be easiest actions as non-significant changes if significant changes hadno impact on PTR, type testing and technical documentation.

 

Scenario 4

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Significant change yes

PTR + Type Testing  no

Technical documentation yes

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This is typical changes as IFU, revision of production site, revision of critical validation as shelf life, just revise Chinese technical documentation.

Rule of thumb, if technical documentation will be revised, checked and released in more than 6 months, consider bringing the significant changes in next registration.

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Scenario 5

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Significant change no 

PTR + Type Testing yes

Technical documentation yes

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Now we are in the level of non-significant changes. The critical impact factor is on PTR and testing. Even it was a change as dimension of a critical component in PTR, we recommend to include it in PTR after agreement of Chinese lab. These non-significant changes could be included in technical documentation but doesn’t need to.

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Scenario 6

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Significant change no 

PTR + Type Testing no

Technical documentation yes

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The manufacturer have non-stop of design changes. If they are related for typical Chinese significant changes and PTR, it really doesn’t matter, feel free to integrate it in technical documentation as new device description, new report of verification and validation or new marketing history.

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Scenario 7

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Significant change no

PTR + Type Testing yes

Technical documentation no

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The effort is similar to scenario 5. Update PTR and testing.

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Scenario 8

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Significant change no

PTR + Type Testing no

Technical documentation no

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This is simplest as bugfix of software without impact on PTR, Type testing and TD. Just include the change in current registration. You could update software file which is not necessary.

 

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