1. Product name

Frequently asked questions: English, trademark, scope of application and other words are appended before the common name, or the common name contains promotional words and other content, such as AB type high frequency Electrosurgery, multi-functional radio frequency therapy equipment, etc.

The Chinese naming of medical device products should comply with regulatory requirements and should be based on the working principle and characteristics of the product. There should be no modifiers such as English, trademark, and scope of application. For products with English names, their English name descriptions should be consistent with the original materials such as marketing documents, instructions, labels, etc.

2. Product specifications and models

Frequently asked questions: Incorrect or omitted specifications and models, etc.

When filling out the medical device product registration application form, pay attention to the consistency of the product specifications and models with other registration documents, especially the consistency with the marketing instructions of the country of origin, and also check whether there are any omissions.

3. Product structure and scope of application

Frequently asked questions: The description of product structure and scope of application is inaccurate, vague, or changed at will.

When filling out the medical device product registration application form, you should carefully check and combine the relevant contents of the registration documents such as instructions and marketing certificates, accurately describe the structure, composition and scope of application of the registered product, and respect the original instructions and marketing certificates. and other contents in the registration information.

4. Production location address

Frequently asked questions: The registered address and production address are confused, or the address information filled in does not match the actual situation.

The actual production address of the product should be verified and consistent with supporting documents such as production licenses and quality management system documents.