I. Company registration and qualification requirements
First of all, medical device companies need to register and obtain legal business licenses. At the same time, according to relevant laws and regulations, medical device enterprises also need to obtain corresponding medical device business licenses. These certificates are the basis of medical device business activities.
Second, the personnel qualification requirements
Medical device companies need to have corresponding personnel qualifications. The person in charge of the company and the personnel in key positions need to have professional knowledge and experience related to medical devices and pass the training. In addition, the company also needs a certain number of professional and technical personnel to be responsible for product quality control and technical support.
Three. Business premises, equipment and facilities
Medical device enterprises need to have business premises and equipment and facilities that meet the requirements. The business premises shall meet the health and safety requirements, and the equipment and facilities shall meet the needs of product production, storage and transportation. At the same time, the company also needs to establish a sound warehouse management system to ensure the quality and safety of products.
Four, quality management system requirements
Medical device enterprises need to establish and implement a quality management system to ensure the quality and safety of products. Including formulating product quality standards and inspection methods, establishing product traceability system, and monitoring and evaluating product quality. Effective implementation of quality management system is an important measure to ensure public health and safety.
To sum up:
To start a medical device company, it is necessary to meet a series of conditions, including company registration, personnel qualifications, business premises, equipment and facilities, quality management system and other requirements. The satisfaction of these conditions is the basis for ensuring the compliance of medical device enterprises and ensuring public health and safety.
Legal basis:
Regulations on the supervision and administration of medical devices
Article 4 provides that:
The state implements classified management of medical devices according to the degree of risk. There is no need for licensing and filing for operating Class I medical devices, filing management for operating Class II medical devices and licensing management for operating Class III medical devices. The medical device business license is valid for 5 years, indicating the license number, enterprise name, legal representative, person in charge of the enterprise, domicile, business premises, business mode, business scope, warehouse address, issuing department, issuing date and validity period.
Regulations on the supervision and administration of medical devices
Article 26 provides that:
Medical device business enterprises and users shall not operate or use medical devices that have not been registered according to law, have no certificate of conformity or are expired, invalid or eliminated.