1, submit application information to the relevant department;
2, the relevant department accepts the application;
3, on-site inspection of the site and review of the product;
4, the issuance of Class III medical device license.
Classification standards of medical devices:
1, according to the risk level: medical devices are classified into Class I, Class II and Class III according to the risk of use, of which Class I has the lowest risk and Class III has the highest risk;
2, according to the purpose of use: medical devices are categorized according to the different purposes of use, such as prevention, diagnosis, treatment and guardianship;
3, according to the use of According to the conditions of use: divided into devices operated by medical professionals and devices available to ordinary consumers;
4, according to whether the implant: medical devices are divided into two categories of implants and non-implants;
5, according to whether it is a one-time use: medical devices can be divided into one-time-use and multiple-use devices.
In summary, the process of applying for a Class III medical device license includes submitting application information to the relevant departments, departmental acceptance, on-site investigation of the site and product review, and ultimately the issuance of the appropriate license, the entire process reflects the standardization of medical device business activities and strict supervision.
Legal basis:
Methods for the Administration of Medical Device Business License
Article 11
Application for a Medical Device Business License shall be submitted to the following information: I. Application Form for Medical Device Business License; II. Pre-approval of the business name issued by the administrative department for industry and commerce documents proving the name of the enterprise; III. Proposed enterprise Quality management personnel of identity cards, academic or professional title certificates and copies of personal resume; four, the proposed business organization and functions; five, the proposed business registered address, warehouse address location map, floor plan (indicating the area), proof of ownership of the house (or lease agreement) copies; six, the proposed business product quality management system, documentation and storage facilities, equipment directory; seven, the proposed business scope of business.