Common problems: additional English, trademarks, scope of application and other words before the common name, or the common name with promotional words and other content, such as AB high-frequency scalpel, multifunctional radiofrequency therapeutic instrument, and so on.
The Chinese name of medical device products should be named in accordance with the regulatory requirements, and at the same time to be named in conjunction with the working principle and characteristics of the product, there can be no English, trademarks, scope of application and other modifiers. And products with English names, the English name description should be consistent with the original information such as listing documents, manuals, labels and so on.
Two, product specifications
Common problems: wrong specifications, omissions and so on.
When filling out the application form for registration of medical devices, we should pay attention to the consistency of the product specifications with the rest of the registration documents, especially with the country of origin of the listing instructions, but also pay attention to verify whether there are omissions.
Three, the product structure and scope of application
Common problem: the product structure and scope of application of the content of the description is not allowed, vague, or arbitrary changes.
When filling out the application form for registration of medical device products, we should carefully check and combine the content of the registration documents such as manuals and listing certificates to accurately describe the structural composition and scope of application of the registered products, and to respect the content of the original manuals and listing certificates and other registration data.
Fourth, the address of the production site
Frequently asked questions: the registered address and production address confusion, or fill in the address information does not match the actual situation.
Should verify the actual production address of the product, and to be consistent with the production license, quality management system documents and other supporting documents.