Study On The Countermeasures Of Standard Administration Of Chinese Medical Devices

Medical devices have become an increasingly important measure in course of preventing Disease, diagnoses, treatment and health care, playing more important role in medical field. But same as drug, medical devices also induce adverse event. The number and harm of adverse event induced by medical devices should not be ignored.Some developed counties, such as America and EU, have established a relative perfect management system for medical devices by researching safety and risk change. Although monitoring management level for medical devices is better than ever in our country. Adverse event induced by medical devices always occurred and the perfect monitoring management systems have not be established. The distance to carry out standard management of medical devices still exist.Therefore many problems of monitoring management for medical devices in our country are analyzed in the paper and the relative countermeasures are bougt forward. The research aim standard management of medical devices. At the same time, the paper introduce medical devices involved in the management status, management pattern, law management, quality management, monitoring management of adverse event and drug recall, and monitoring management pattern and characteristics of developed countries, such as America an EU. The difference between our country and developed countries is studied by analyzing their monitoring management of medical devices, hoping to use the advanced experience of developed countries for reference.The author hopes to bring forward corresponding management countermeasures and advises for standard management of medical devices in our country and establish perfect , systemic , standard monitoring management systems for medical devices.