I, the importance of the main responsibility of the enterprise
Medical devices as a special product directly related to people's lives and health, its quality and safety is critical. Enterprises as the production of medical devices, the main business, bear the direct responsibility to ensure product quality. The implementation of the main responsibility of enterprises, is to ensure the quality and safety of medical devices cornerstone.
Two, the establishment of a sound quality management system
Enterprises should be based on the "supervision and management of medical devices regulations" and other relevant laws and regulations, the establishment of a sound quality and safety management system for medical devices, including the development of quality management system, the establishment of a quality management organization, equipped with full-time quality management personnel. Through the perfect quality management system, to ensure that medical devices from research and development, production, circulation to the use of the whole process under control.
Three, strengthen quality control and risk management
Enterprises should strictly control the procurement of raw materials for medical devices, the production process, product testing and other links to ensure that the products meet the relevant standards and requirements. At the same time, to strengthen risk management and hidden trouble detection, timely detection and treatment of problems that may affect product quality, to prevent potential safety risks.
Four, cooperate with the supervision and inspection of the regulatory authorities
Enterprises should actively cooperate with the supervision and inspection of the regulatory authorities, truthfully provide relevant data and information, and accept on-site inspections and sampling tests. For the problems and rectification requirements put forward by the regulatory authorities, enterprises should be timely rectification and feedback rectification.
V. Strengthen staff training and quality control awareness
Enterprises should strengthen the training and education of employees to improve the staff's understanding of the quality and safety of medical devices and attention. Through training, the staff to master the relevant knowledge and skills to improve the quality control ability and risk management level.
In summary:
Enterprises implement the supervision and management regulations of the main responsibility for the quality and safety of medical devices, which is an inevitable requirement to ensure the quality and safety of medical devices. Enterprises should establish and improve the quality management system, strengthen the quality control and risk management, cooperate with the supervision and inspection of the regulatory authorities, strengthen the staff training and quality control awareness, to ensure the safety and effectiveness of medical device products.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article VI states:
Medical device registrants, filers should strengthen the quality management of the whole life cycle of medical devices, for the development, production, operation, and use of the whole process of the safety and efficacy of medical devices to bear the responsibility according to law.
Medical Device Supervision and Administration Regulations
Article 30 states:
Medical device registrants, filers, commissioned manufacturers should establish and implement product traceability system to ensure that the product can be traced.
Medical Devices Supervision and Administration Regulations
Article 70 provides:
Medical device manufacturers and operators, the use of units in accordance with the provisions of this regulation to carry out monitoring of adverse events of medical devices, not in accordance with the requirements of the report of adverse events, or the monitoring of adverse events of medical devices and technical institutions, the supervision and management of pharmaceuticals in charge of the investigation of adverse events carried out by the department not to cooperate The department in charge of drug supervision and management shall order correction, give a warning, and impose a fine of 50,000 yuan or more than 100,000 yuan; if the circumstances are serious, shall order the suspension of production and business, until the original licensing department to revoke the registration certificate of the medical device, medical device production license, medical device license, to the legal representative of the unit of the illegal, the main person in charge, directly responsible for supervisory personnel and other responsible personnel, confiscated. The illegal behavior occurred during the period from the unit's income, and impose a fine of more than 30% of the income obtained more than three times the following fine, within 10 years prohibited from engaging in the production and management of medical equipment activities.