The handling of Class II medical device business filing certificate needs to follow a certain process.
First of all, the applicant needs to submit an application and provide relevant documents, such as business license, organization code documents, tax registration documents, legal representative identification.
Secondly, the applicant needs to submit the application form for medical device business filing and fill in the relevant information, such as the business scope, business location, the type of business instruments.
Then, the applicant also needs to submit the medical device business filing approval form, and prepare relevant information, such as quality management system certification, quality management system documents, the operator's responsibility, business site photos.
Finally, the applicant needs to submit the medical device business filing certificate, and prepare relevant information, such as the applicant's identity, the operator's responsibility, business site photos.
After the submission of the above application materials, the applicant is also required to pay the relevant fees, such as filing fees, etc., and pay the business tax, etc. to the relevant authorities.
After completing the above steps, the applicant can apply to the relevant departments to receive the Class II medical device business record certificate, which proves that it has the qualification to operate.