Is It Necessary To Classify A Newly Developed Medical Device That Has Not Been Included In The Classification List Before Registration?

According to Article 16 of the “Regulations on the Supervision and Administration of Medical Devices”,: For newly developed medical devices that have not been included in the catalogue, the administrative counterpart can directly apply for product registration in accordance with the provisions of these regulations regarding the registration of III medical device products. Alternatively, after judging the product category according to the classification rules and applying to the drug regulatory department for category confirmation, the administrative counterpart can apply for registration or filing in accordance with the provisions of these regulations.