One or two types of medical devices do not need a license to operate, but two types need to be filed.
According to the "supervision and management of medical devices business approach" Chapter I, Article 4:
In accordance with the degree of risk of medical devices, medical devices business implementation of classification management. The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices to implement the record management, the operation of Class III medical devices to implement licensing management.
Measures for the Supervision and Administration of Medical Device Business is to strengthen the supervision and administration of medical device business, standardize the behavior of medical device business, to ensure the safety and effectiveness of medical devices, according to the "supervision and administration of medical devices regulations". Issued by the State Food and Drug Administration on July 30, 2014, since October 1, 2014 shall come into force.
Extended Information
Supervision and management
1, food and drug supervision and management department shall regularly or irregularly on the medical device business enterprises in line with the requirements of business quality management standards for supervision and inspection, and urge enterprises to standardize the operation of activities. Class III medical device business enterprises in accordance with the requirements of the quality management standard for the operation of medical devices to carry out a full program of self-examination of the annual self-examination report should be reviewed, if necessary, to carry out on-site verification.
2, provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall prepare the administrative region of the medical device business supervision and inspection program, and supervise the implementation. Municipal food and drug supervision and management department shall develop the administrative area of the medical device business enterprise supervision focus, inspection frequency and coverage, and organization and implementation.
3, food and drug supervision and management departments to organize supervision and inspection, should develop inspection programs, clear inspection standards, factual records of on-site inspection, the results of the inspection will be informed in writing to the inspected enterprise. The need for rectification, should be clear rectification content and rectification period, and the implementation of follow-up inspection.
4, food and drug supervision and management departments should strengthen the sampling and testing of medical devices.
5, food and drug supervision and management departments at or above the provincial level should be based on the findings of random testing and timely release of medical device quality bulletin.
Baidu Encyclopedia - Medical Device Management Supervision and Administration