In the classification catalog inquiry can not be classified, you can apply for classification definition, domestic products to the provincial bureau to apply, foreign products to the national bureau to apply.
2, the same class III declaration
Can be submitted directly in accordance with the third class of medical devices.
3, special products
This special product refers to the innovation, priority, combination of drugs and equipment products, it has its corresponding process, can be very quickly for the determination of the category.
Expanded information:
Medical devices are categorized according to the degree of risk, we have previously said that the total **** three kinds of categories:
Category I is low risk,
Category II is medium risk
Category III is high risk.
Said so you may not have a clear understanding, so let's say,
One category is band-aids, masks, cotton swabs, disposable gloves and such products.
The second category is a disposable need to sterilize the majority of products, LCD vision meter, optometry, hearing aids, wheelchairs, etc. are, after seeing everyone has an outline to know how to do it.
Three categories are implanted in the body of the product, which is only roughly one, is better so that we can easily understand, the brain has an impression of the specific classification is certainly not so simple and rough one-size-fits-all.