Obtained the Class Ⅲ Medical Device License

Definition of Class III medical devices

The state implements classified management of medical devices according to the degree of risk. Class III refers to medical devices that are implanted in the human body; used to support and maintain life; and are potentially dangerous to the human body, and their safety and effectiveness must be strictly controlled. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripsy, vascular endoscopes, etc.

Due to the high-risk nature of Class III medical devices, relevant departments are very strict in reviewing and issuing licenses. Enterprises need to have advanced production equipment, professional technical personnel, and a complete quality management system. At the same time, products need to go through a rigorous clinical trial verification and approval process, which generally requires a lot of time, money, and manpower costs, and the entire process may take several years.

JCMED is very honored to be able to obtain the certification. Obtaining this license means that we have met the country's strict standards and requirements in technology research and development, production management, quality control, etc., and have the ability to produce and sell high-risk medical device products, can enter a wider market, and enhance the company's competitiveness and market position.