Active Medical Devices CFDA Registration Units Partition

On April 21st 2017, Center for Medical Device Evaluation (CMDE) issued ‘Medical Device Registration Unit Partition Principle (exposure draft)’. The regulation gave the explanations of the division of different registration units. And for medical devices in the different registration units, they have to obtain the different CFDA Registration Certificates.

Three major kinds of medical devices:

The main points for the active medical devices registration units.

Different variety of active medical devices will be included in the different registration units.
Same kind of products with different technical principle will be managed in different registration units.Ex: Air pressurized oxygen tank and oxygen pressurized oxygen tank should be divided into different registration units
Active medical devices have same technical principle, but the main structures and components are different with significant influence on the product safety and effectiveness. They will be managed in various registration units.
If the clinical intended use or action mechanism are different that caused by the product performance differences, these products will be in different registration units.
If the same kinds of products have the identical technical principle and structure design but the applicable scopes are different, they should be in the different registration units.Ex: Endoscopes with different applicable scope.
The passive consumable items cooperated with active medical device should be registered in the different units with the active medical device.
Two independent active medical devices working cooperatively in the same clinical intend use should be in the different registration units.
In general, the active medical device attachment and the connecting mainframe would be in the same registration unit, but there is some special situation for the attachments in the different registration units. The attachments that registered separately and managed as the medical devices will be in the different registration units. The attachments with different intended use will be in different registration units. Active attachment and passive attachment will be divided into the different registration units as usual. But if active attachment and passive attachment are in the same sterile package, they can be in the same registration unit.
The disposable sterile products and reusable products will be in the different registration units.
If there are a most complex model and other simpler models with the identical applicable scope, function and structure, they can be in the same registration unit. But if there are huge differences among products applicable scope, function and structure, these products should be in the different registration units.

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

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