If you want to operate a medical device, you need to register, obtain a license, and file. In the past, you may need to go to the local industrial and commercial bureau to handle it. Now it\u2019s not so troublesome. Just do it online, which is convenient and trouble-free. Medical equipment online filing, how to operate, kaen Disposable face mask manufacturer let me talk about it in detail. First of all, the online filing process of the second-class medical device: 1. Materials to be submitted when applying for the second-class medical device business record: 1, business license; 2. The identity certificate, education background or title certificate of the legal representative, the person in charge of the enterprise, and the person in charge of quality; 3. Organization and department setting description; 4. Description of business scope and business method; 5. Geographical location map, floor plan, housing property certificate or lease agreement of business premises and warehouse address; (with housing property certificate) 6. Operating facilities and equipment catalog; 7. Document catalogues such as operating quality management system and working procedures; 8. Encourage the use of computer information management systems; 9. Authorization certificate of the manager; 10. Scanned version of the signed and official seal application form; 11. Other supporting materials. 2. Instructions for filling out the filing materials for applying for the second-class medical device operation: 1. The copy of the business license should be the same as the original, and the period should be within the validity period; 2. The person in charge of enterprise quality must provide a personal resume, resignation certificate and more than 3 years of medical device operation quality management work experience. The personnel engaged in quality management work in the second type of medical device operation enterprise shall be on-the-job, and the Companies operating in equipment, contact lenses, hearing aids, etc.; 3. The organization and department setting instructions shall be provided by the applicant enterprise and filled out according to the actual situation, and shall meet the basic setting requirements; 4. The business scope of medical devices filled in should conform to the management category and class code name specified in the medical device classification catalog; 5. The business premises and warehouses should be suitable for the actual needs of the business scale of the enterprise. The business premises and warehouses shall not be located in residential residences, military management areas (excluding leaseable areas) and other places that are not suitable for business operations. The floor plan needs to draw each functional zone and zone management. The business premises, warehouses, and living quarters must be separated and relatively isolated; 6. The business premises have office conditions. If it is a wholesale and retail enterprise, the business premises must have a counter. The warehouse shall be equipped with facilities and equipment suitable for the business scope and scale; 7. The document catalogues such as the operating quality management system and working procedures must meet the requirements of the "Medical Device Operating Quality Management Regulations"; 8. Provide computer management system with functional introduction and operating instructions on medical device management; 9. The authorization certificate of the handler shall include the client, the entrusted matters, and the time limit for the entrustment. The principal and the entrusted person shall sign at the same time and attach the copies of the ID cards of both parties and the official seal of the enterprise; 10. The applicant logs in to the State Food and Drug Administration, and the legal representative of the application form signs and affixes the official seal of the enterprise. Click to enter the "Medical Device Production and Operation License Filing Information System" in the "Licensing Service-Online Services" column on the homepage. After filling in the information in the system as required, temporarily save it \u2192 automatically generate a barcode application form for the company to print \u2192 online Sign under the seal \u2192 upload the application form after scanning and signing; 11. Provide a roster of enterprise personnel according to the content of the organization and department. 3. Process of handling the second-class medical device business registration: 1. Telephone consultation or on-site consultation, prepare application materials; 2. Online declaration and submission of paper materials; 3. The staff accepts online; 4. Staff with warehouses conduct site surveys; 5. Receive the second-class medical device business record. There are some options for online filing of Medical Devices equipment. You still need to see clearly. The information you fill in is best to be verified. Although it is convenient to operate, the review mechanism is unchanged. This still needs to be taken seriously.