The Class III Medical Device License is a license whose business scope includes Class III medical devices (including implantable materials and surgical instruments).
To apply for a Class III medical device license, companies need to meet the following conditions:
1. Have a registered capital appropriate to the scope of business.
2. With the scale of operation of the warehouse and corresponding equipment and facilities.
3. With the business scope of the quality management organization or quality management personnel.
4. With the scope of business with the appropriate mode of operation.
5. With information management systems appropriate to the scope of business.
6. After-sales service capabilities appropriate to the scope of business.
In addition, the company also needs to meet some other conditions, such as meeting the requirements of the quality management standard for medical device business, obtaining a medical device manufacturing license or medical device registration certificate and so on.
To apply for a Class III medical device license, companies need to apply in accordance with relevant regulations and requirements.