Wearable Medical Device Registration Unit（key points of active medical device registration unit）

According to ‘Medical Device Registration Unit Partition Principle (exposure draft)’ issued by CMDE (Center for Medical Device Evaluation, CFDA) on April 21st 2017 , medical device registration units are divided into three main columns: active medical device, passive medical device and in vitro diagnostics. Wearable medical device registration unit partition follows the registration unit partition of general medical device. And most of the wearable medical devices belong to active medical device. Here are the main points for the active medical device registration unit.

Active Medical Device
1. Different kinds of active medical device will be included in different registration units.
2. Same kind of products with different technical principle will be managed in different registration units.
3. Same kind of products with same technical principle, but the main structure and components are different that have significant influence on the product safety and effectiveness, will be managed in various registration units.
4. If the clinical intended use or action mechanism is different because of the product performance difference, these products will be in different registration units.
5. If the same kinds of products have the similar technical principle and structure design but the applicable scopes are different, they should be in different registration units.
6. The passive consumable items used in/with active medical device should be registered in different units with the active medical device.
7. Two independent medical devices working cooperatively in the same clinical intend use, should in different registration units.
8. In principle, 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.
In two conditions, the attachments that register separately and manage as the medical devices will be in the different registration units:

The attachments with different intended purpose will be in different registration units
Active attachment and passive attachment will be in the different registration unit as usual. But if they are in the same sterile package, they can be in the same registration unit

9. The disposable sterile products and reusable products will be in the different registration unit.
10. If there is a most complex model and other simpler models with the similar 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 unit in principle.

Related links

Wearable Medical Device Registration in China

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.