Enterprises operating Class III medical devices should have a quality management system that meets the requirements for quality management of medical device business, device management system, supplier management, quality risk management, adverse event management, training and awareness-raising, regulatory compliance, follow-up and after-sales service system guarantee.
1, quality management system: companies need to establish and implement a quality management system in line with ISO 13485 and other relevant international standards or national standards. This system should include the organizational structure of quality management, division of responsibilities, operating procedures, records and document management.
2, device management system: companies need to establish a sound medical device procurement, warehousing, storage, sales and traceability management system. These systems should include classification management of devices, inventory management, quality inspection and control, product traceability and other aspects.
3, supplier management: enterprises should establish a supplier management system, supplier assessment and selection, and sign quality agreements and contracts with suppliers. At the same time, enterprises need to establish a supplier tracking and evaluation mechanism to ensure that the purchased medical devices meet the quality requirements.
4, quality risk management: enterprises need to carry out quality risk analysis and assessment, identify and assess possible quality risks, and develop appropriate control measures and emergency plans.
5, adverse event management: enterprises need to establish a sound adverse event management system, timely reporting and handling of adverse events, and statistics and analysis to improve product quality and monitor safety.
6, training and awareness: companies need to provide employees with medical device knowledge training and quality management training to enhance the professionalism and quality awareness of employees.
7. Regulatory compliance: Enterprises need to understand and comply with relevant national and local laws and regulations to ensure compliance, safety and efficacy in the business process.
8. Follow-up and after-sales service: Enterprises need to establish a customer feedback mechanism to solve users' problems and complaints in a timely manner, as well as conduct product traceability and recall work.
Notes needed to operate Class III medical devices
1, legal qualifications: to ensure that the business of medical devices in line with relevant laws and regulations, and have legitimate business qualifications. Apply for and obtain a medical device manufacturing/management license or record. Comply with national and local regulatory requirements.
2. Product quality: Choose qualified, safe and effective medical device suppliers or manufacturers. Quality inspection and acceptance of incoming medical devices should be carried out and traceable file records should be established. Ensure that the medical devices sold meet the quality standards and quality and safety requirements.
3, product registration and filing: In accordance with the requirements of the regulations, the medical devices need to be registered or filed for the appropriate procedures. Ensure that has obtained the appropriate registration certificate or record certificate, in line with regulatory requirements for sales.