Two types of equipment for the record online application process

Since the outbreak of the epidemic, the demand for masks is getting higher and higher, so there are a lot of companies or individual bosses, want to produce or sell masks to make a profit, and we sell masks usually need some proof of qualification, which is essential to a qualification, is the class II medical device filing certificate, how to apply for the record of Class II medical devices, Class II medical device online filing process is what ah? The problem is that it is not easy to find the best way to get the best out of a medical device. The first thing you need to do is to get your hands on a new one, and then you can get your hands on a new one.

The second class of medical equipment online filing process and information

What qualifications are needed to sell masks?

First of all, the second class of medical devices online filing process:

First, apply for the second class of medical equipment business record should be submitted to the information:

1, business license;

2, the legal representative, the person in charge of the enterprise, the person in charge of quality of the identity card, education or title certificate;

3, the organization and the department set up to explain;

4, the scope of business, the business mode of explanation

5, business premises, warehouse address of the geographic location map, floor plan, documents proving ownership of the house or lease agreement; (with documents proving ownership of the house)

6, business facilities, equipment directory;

7, business quality management system, work procedures and other documents directory;

8, to encourage the use of computerized information management systems;

9, the operator's authorization certificate; 10, signed and stamped with a certificate of authorization. p> 10, signed and stamped application form scanned version;

11, other supporting materials.

Second, apply for Class II medical device business record materials to fill out the instructions:

1, a copy of the business license should be the same as the original, the period of validity;

2, the person in charge of quality of the enterprise shall provide a resume, proof of separation and more than 3 years of experience in quality management of medical device business, Class II medical device business enterprises engaged in quality management personnel should be on duty in the job, to the Engaged in diagnostic reagents, implantation of interventional medical devices, corneal contact lenses, hearing aids and other business enterprises;

3, organizational structure and departmental setup by the applicant company to prepare their own, fill in the actual situation, should meet the basic setup requirements;

4, fill in the scope of medical devices should be in line with the medical device classification directory of the management of the category, the class code name;

5, the business premises and warehousing Should be suitable for the actual needs of the scale of business operations, business premises and warehouses shall not be located in residential areas, military management areas (excluding leasable areas) and other places not suitable for business. Floor plans need to draw the functional zoning, zoning management. Business premises, warehouses, living areas need to be separated and relatively isolated;

6, business premises with office conditions, such as wholesale and retail enterprises, business premises shall be placed on the counter. The warehouse should be equipped with facilities and equipment appropriate to the business scope and scale of operation;

7, business quality management system, work procedures and other documents directory must be consistent with the "Code for Quality Management of Medical Devices" requirements;

8, to provide a computerized management system on the operation of medical equipment management functions and operating instructions;

9, the operator's authorization certificate should include the principal, the entrusted matters

10, the applicant logged on to the State Food and Drug Administration, the application form signed by the legal representative and stamped with the official seal of the enterprise.

Home "license services - online" column in the "medical device production and operation license filing information system" click to enter the system in accordance with the requirements to fill in the information after the Temporary save → automatically generated with a barcode form of the application form for the enterprise to print → offline seal signature → upload a scanned seal signature application form;

11, according to the content of the organization and departmental settings to provide a roster of business personnel.

Third, for the second class of medical devices business filing process:

1, telephone consultation or on-site consultation, prepare the application materials;

2, online reporting, paper reporting;

3, the staff online acceptance;

4, there is a library of staff on-site inspection;

5, to receive the second class of medical devices business filing.