Division of Medical Device Registration Unit in China

According to the “Guidelines for the division of medical device registration units”, the registration unit of a medical device refers to a unit composed of a medical device product having the same or similar technical structure, performance index and intended use. The division of the registration unit focuses on factors such as the technical principle, structural composition, performance index, scope of application, and packaging specifications of in vitro diagnostic reagents.

Applicant needs to refer to the guiding principles and select the medical device to be registered into the correct registration unit. For medical device with multiple models to be registered, it is also necessary to consider the differences between each model and whether they belong to the same or different registration units. Proper selection of the appropriate registration unit will be of great help to the smooth progress of the registration process. If the wrong or inappropriate registration unit is selected, the medical device registration application will be rejected.

The following is a reference for the division of medical device registration units by summarizing the guiding principles:

Type

Recommend to divide into different registration units

Can be considered as the same registration unit













Active Medical Device

Different types of active medical devices

Active medical device accessories and connected hosts can be divided into the same registration unit. If active and non-active accessories are in the same aseptic package then they do not need to be divided into different registration units.

Same Type, but different technical principle

Although the device consists of a number of different types or devices/components with different technical principles and scope of application, these devices/components are connected by an inseparable configuration, rather than a simple pluggable connection. Then, it can be divided into same registration unit.

Same technical principle, Same type, but different product design structures.

If there is a most complex model, other models are simplified versions of the most complex models in terms of scope of product function and structure. In principle, these models can be considered as the same registration unit. Applicants need to submit specific instructions and supporting documents for the above situations.

Different performance indexes result in different clinically uses or mechanisms of action

The technical principle of the same product, the difference in design structure and performance index will not lead to the active medical device with different clinical intended use or different mechanism of action.

Same technical principle, Same Product design structures, Same type, but different range of application

Independent active medical devices used in the same clinical application

Disposable aseptically packaged products and reusable products should be classified into different registration units.














Non-Active Medical Device

Different technical principles

The main constituent materials are used as a single unit

Different surface modification or surface structure causes the change of safety and validity

Same Main materials, same range of applications but different structure which will affect the safety.

Different structure or different processing method causes different performance index

Critical or special production process, including sterilization process different

The structure, performance index and application range are the same, the sterilization process is different, but the sterilization process does not affect the product performance.

Same main materials, same structure same range of application, different combination product cause different performance index

Different critical part or structure cause different range of application or performance index

Combined with medication or not

For a combination of tools that have been used for the same surgical purpose

Disposable aseptically packaged products and reusable products should be classified into different registration units.

A single category of surgical tool for use with the same surgical purpose

The technical principle, structural composition, performance index and scope of application of the product are the same, and only the size of the specification is different.

IVD

In vitro diagnostic reagents or In vitro Diagnostic device

A single kit refers to the form in which all reagents or partial reagents used to complete a certain or a certain type of test are combined, and a single reagent refers to all reagent components that constitute the kit in a separate form. A single kit or a single reagent can be registered as a registration unit, as needed, the type of kit is determined by the highest category involved in its intended use, and the category of a single reagent is determined according to its intended use.

 

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