The detailed description of the product registration process of ultrasonic scaler is as follows:
Determine the product classification: Determine the applicable medical device classification code according to the characteristics and use of the product.
Preparation of registration application materials: Prepare relevant registration application materials according to the requirements of the National Medical Products Administration. These materials may include product specifications, technical specifications, manufacturing processes, quality management system documents, clinical trial data, etc. Ensure the accuracy and completeness of the documents.
Select the registration type: Determine the applicable registration type based on the characteristics of the product and the existing registration requirements, such as new registration, change registration, renewal registration, etc.
Submit the registration application: Submit the prepared registration application materials to the National Medical Products Administration. Fill out the necessary application** and provide all required information. Ensure the completeness and accuracy of the application documents.
Application review: The NMPA will review and evaluate the submitted registration application. They may request supplemental materials or undergo further testing, evaluation, or audit. An on-site audit may also be arranged to ensure the quality and compliance of the product.
Approval and Obtaining a Device Number: If the registration application is approved, the NMPA will issue a Device Number (Registration Certificate) confirming that your ultrasonic scaler complies with the regulations and requirements in China. The machine number is a necessary document for the legal sale and use of products.
In addition, clinical trials may also be required for medical devices that need to demonstrate their safety and efficacy. The specific process and requirements may vary depending on the type of product and the country of registration, and it is recommended to consult with your local drug regulatory authority or professional body for more information.