Divided into cases, some need to test, some do not need.
Based on the Chinese Medical Association on the national "large medical equipment license" renewal work notice:
Renewal object: all hold "large medical equipment user certificate of qualification" for five years (to the date of issuance shall prevail) of the relevant professionals. Physicians must hold a practicing physician's certificate, technicians, physicists must have the appropriate title.
Exempted from the license conditions:? ① exempt from the test to obtain "large medical equipment users qualified" certificate of the relevant professionals? ② engaged in clinical work for more than 30 years, and has obtained a senior title or deputy senior title of the three hospitals related professionals.
Examination conditions: does not meet the 2, 3 conditions must participate in continuing education in the nature of the pre-test training, by the national examination to re-issue the certificate. The training will focus on new knowledge, new technologies, to practice first principle, test questions to clinical-based, strengthen the operational ability to train.
Expanded Information:
Technical Requirements for Medical Devices
The hospital can't afford to have a power outage, and if there is a problem with the power outage, it may threaten the patient's life safety. Similarly, medical equipment can not be power outages, so medical equipment has very strict requirements on the specifications of the power supply. Therefore, there are special specifications in the design of medical equipment batteries.
China's demand for medical electronics is growing faster than the global average - driven by a huge population base, an aging population that is increasing rapidly year after year, and people's growing awareness of their health, as well as by national policies, healthcare informatization, and the technological revolution. China's medical electronics market demand continues to maintain rapid growth.
In addition, China has begun to implement its 12th Five-Year Plan, which includes the following three goals for the future development of medical equipment:
1) Accelerate the development of the domestic medical equipment industry;
2) Implement a unified purchasing system;
3) Domestic healthcare institutions should prioritize the purchase of domestically produced medical equipment. With the gradual implementation of this health care reform program, domestic medical equipment manufacturers are ready to take advantage of this rare opportunity to develop a new generation of medical equipment.
In addition to the need for medical equipment to meet internationally recognized standards, other factors such as basic performance and whether or not the power supply used meets specifications are very important because the patient's health will be directly or indirectly affected by it.
But if the power supply of any electronic medical device related to patient care, clinical treatment, health monitoring, or imaging scanning fails to energize, loses power, or is otherwise inoperative, the consequences can have a direct impact on the patient's health, and may even cause transient or permanent harm to the patient.
Taking laboratory instruments or diagnostic equipment as an example, once the power supply problem occurs, it will lead to medical personnel not being able to make a correct diagnosis in time, and sometimes even have to do a few more tests, which is a waste of time, and also aggravates the mental burden of medical personnel and patients.
In addition, if the power supply of a medical device fails, even if it does not pose an immediate safety issue, it will not be able to perform its basic functions, so medical device developers not only need to plug design loopholes in the conceptualization phase of the product, but also need to manage the risks throughout the product's lifecycle in order to prevent the device from malfunctioning.
Baidu Encyclopedia - Medical Devices
Baidu Encyclopedia - Code of Practice for the Quality Management of Medical Devices