1. Apply for classification definition
If you cannot find the classification in the classification directory, you can apply for classification definition. Domestic products apply to the provincial bureau, and overseas products apply to the national bureau.
2. Applications for the same category III medical devices
can be submitted directly as category III medical devices.
3. Special products
This special product refers to an innovative, priority, drug-device combination product. It has its corresponding process and can quickly determine the category.
Extended information:
Medical devices are classified according to risk levels. As we said before, there are three categories:
One category is Low risk,
Category 2 is medium risk,
Category 3 is high risk.
You may not have a clear understanding, so let’s put it this way,
The first category is products such as band-aids, masks, cotton swabs, and disposable gloves.
The second category is mostly disposable products that need to be sterilized, such as LCD eye charts, optometrists, hearing aids, wheelchairs, etc. After seeing them, everyone can have an outline and know what is going on.
The third category is products implanted into the human body. This is just a general description to make it easier for everyone to understand. There is an impression in the mind. The specific classification is definitely not so simple and crude.