9 Cases Of Applying for Classification And Definition Of China Medical Devices
In China‘s national supervision and management of medical devices, there are classifications and definitions, there are Ⅰ class, Ⅱ class and Ⅲ class. Different classes have different testing and certification requirements. The Ⅰ class supervision is simpler, and the higher the level, the stricter the supervision. All of these are in accordance with the China national medical device classification rules and medical device supervision and management regulations.
Common names for the classification and definition of medical device products include, identification of medical device product categories, definition of medical device products, and definition of medical device product management attributes and management categories.
According to the classification and definition of medical device products, the objectives of customer consultation projects outside China we often encounter are roughly as follows:
1.Products can be regarded as ordinary electronic products, but they are similar to medical device products. They just don‘t want to be sold as medical device products. If they only want to be sold according to ordinary electronic products, then you can make an application for the classification and definition of medical device products.
The reason is that with the development and updating of electronic products, the boundaries between electronic products and traditional medical device products are becoming more and more blurred, resulting in difficulties in sales. The information and descriptions of such situations need to be fully communicated with the Deeplight,we submit the application definition application according to non-medical device products.
2. The product is an electronic product, but it wants to be sold as a medical device product. This purpose is to define the product as a medical device product. In this case, the application for classification and definition of medical device products can be made.
3. It is not clear what kind of medical device products belong to. I don‘t know which product has been tested and certified. Such medical device products can also be classified and defined.
4. The product has a high general level, belongs to class II or class III products, and needs clinical trials. However, I think the cost of clinical trials is relatively high and the time cycle is long. I don‘t want to do clinical trials. I just want to sell as ordinary products or class I products. In this case, medical device products can also be classified and defined.
5. Newly developed new products, medical devices without reference products, medical devices not listed in the classification catalogue or classification definition announcement. Or compared with the listed products, if the technical principle, structural composition, use position or technical characteristics and intended use of the products have changed significantly, which affects the product classification, it is difficult to determine the management category of medical devices according to the classification catalogue or the notice of classification definition.
6. Medical device products produced in other countries but want to be sold in China can also apply for classification and definition of medical device products.
7. For the confirmation of product category involved in daily supervision, inspection, complaint and report, you can apply for the definition of medical device product classification.
8. For the classification of medical devices applying for the special approval procedure for innovative medical devices, you can apply for the product classification definition of medical devices.
9. Define the attributes of pharmaceutical and mechanical combination products and apply for classification and definition of medical device products.
In the above cases involving the application for the classification and definition of medical devices, you can contact Deeplight for technical consultation.Deeplight provides professional technical services and consulting services.
Under the condition of full communication between the teams of both parties, guide the customers to prepare technical documents and explanatory documents, application documents, preparation materials, etc., and coordinate communication and handling in accordance with national regulations and the wishes of the applicant.
Apply for medical device product classification and definition in a scientific way.
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