Whether a China-made beauty device is submitted provincially or nationally depends on product origin, the type of uncertainty and the current procedure, not on the company’s preferred result heading.
1. Domestic products of uncertain class
Under current guidance, a domestic application concerning an uncertain management class is normally filed with the provincial drug administration where the applicant is located. If the class can be determined from regulations, rules, catalogues and guidance, the province may provide the result directly. Otherwise, it may issue a preliminary opinion and forward the matter for further research.
2. Imported and regional products
Imported products, including relevant products from Hong Kong, Macao or Taiwan, are generally submitted through the classification information system to the competent national technical body. The overseas manufacturer, model, authorization, original data and proposed Chinese version must be aligned.
3. Newly developed products
A new product not yet in the catalogue may follow a separate route. The company must distinguish between whether the product is a medical device at all and, if it is, which class applies.
4. Pre-submission check
- Relationship between applicant and manufacturer.
- Domestic, imported or regional origin.
- Existing catalogue entries and prior decisions.
- Product-status question or class question.
- Frozen production model, instructions and parameters.
- Connection between provincial communication and further review.
The route should follow the official system and competent authority at the time of submission, not another project’s label.