Class III Medical Device License and Class II Medical License

What is the difference between Class II medical device license and Class III medical device license? The operation of Class I medical devices does not require licensing and filing, the operation of Class II medical devices is managed by filing, and the operation of Class III medical devices is managed by licensing. For the operation of Class III medical devices, it is necessary to apply for a medical device operating license, the license is an administrative permit.

China's medical devices in accordance with the degree of risk to implement the classification management, divided into Class I medical devices, Class II medical devices and Class III medical devices.

The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices to implement the record management, the operation of Class III medical devices to implement the license management.

That is to say, for the operation of Class III medical devices, it is necessary to apply for a medical device operating license, which is an administrative license; for the operation of Class II medical devices, only records are required.

Important note: Class III of medical devices does not include Class II. In other words, companies selling both Class II medical devices and Class III medical devices should go through the licensing and record-keeping procedures.

What is the difference between a Class II medical device license and a Class III medical device license?

And the difference between the two in the end?

First, the difference in the application conditions

Application for Class II medical device filing requirements:

1. With more than four relevant staff;

2. With more than 50 square feet of business premises;

3. With the scope of business and business scale appropriate storage conditions, all entrusted to other medical equipment business enterprises can not set up the storage;

4. 4. With the operation of medical devices with appropriate quality management system;

5. With the operation of medical devices with appropriate professional guidance, technical training and after-sales service capabilities, or agreed by the relevant organizations to provide technical support.

Application for Class III medical device license in addition to meet the above requirements also need to meet the following:

1. Enterprises should also have to meet the requirements of quality management of medical devices business computer information management system to ensure that the operation of the product can be traced;

2. The number of personnel to provide a higher number of enterprises must be full of more than six professionals

3. With more than 80 square meters Above the business premises

Second, the difference in application information

Application for Class II medical device business need to submit the following information:

1. business license;

2. the relevant person in charge of the identity card and other documents;

3. organization and departmental setup description;

4. scope of business, the business mode of description;

5. business premises floor plan, location map and Housing lease certificate;

6. Business facilities, equipment catalog;

7. Business quality management system, work procedures and other documents catalog;