Medical devices are not drugs.
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including required computer software.
Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
Purposes are the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.
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Extended information: According to the "Regulations for the Supervision and Administration of Medical Devices": Article 29 Engaged in the business activities of medical devices. There should be with the scale and scope of operation of the business premises and storage conditions, as well as with the operation of medical devices appropriate quality management system and quality management organizations or personnel. Article 30 engaged in the second class of medical equipment business, by the business enterprise to the municipal people's government where the municipal food and drug supervision and management department for the record and submit it to comply with the conditions of Article 29 of these Regulations. Thirty-one engaged in the third class of medical equipment business, the business enterprise shall be located in the municipal people's government food and drug supervision and management department to apply for permission to operate and submit its conditions in accordance with the provisions of Article 29 of these Regulations. The food and drug supervision and management department accepting applications for business license shall be accepted within 30 working days from the date of review, if necessary, the organization verification. To meet the prescribed conditions, permit and issue a medical device license; do not meet the prescribed conditions, not permit and explain the reasons in writing. Medical device license is valid for 5 years. The expiration of the validity of the need for continuation, in accordance with the provisions of the relevant administrative licensing law for continuation procedures. Article 32 of the medical equipment business enterprises, the use of units purchasing medical equipment, should check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system. Engaged in the second, third class medical device wholesale business and third class medical device retail business enterprises, should also establish a sales record system. Record matters include: (a) the name, model, specifications, quantity of medical devices; (b) the production batch number of medical devices, the expiration date, the date of sale; (c) the name of the production company; (d) the name, address and contact information for the supplier or purchaser; (e) the relevant License document number and so on. Incoming inspection records and sales records should be true, and in accordance with the State Council food and drug supervision and management department of the period to be preserved. The state encourages the use of advanced technical means of recording. Article 33 of the transportation and storage of medical devices, shall comply with the requirements of medical device instructions and labeling; temperature, humidity and other environmental conditions have special requirements, should take appropriate measures to ensure the safety and effectiveness of medical devices. Article 34 of the medical device user shall have with the medical device in use varieties, the number of storage space and conditions appropriate. Medical devices should be used to strengthen the technical training of staff, in accordance with product instructions, technical specifications and other requirements for the use of medical devices. Article 35 of the medical device use unit for reuse of medical devices, shall be in accordance with the provisions of the State Council competent department of health planning and management of disinfection and disposal. Disposable medical devices shall not be reused, the used shall be destroyed and recorded in accordance with relevant state regulations. Article 36 of the medical device use units need regular inspection, testing, calibration, maintenance, maintenance of medical devices, should be in accordance with the requirements of the product specification for inspection, testing, calibration, maintenance, maintenance and record, and timely analysis and evaluation. Ensure that the medical device is in good condition, to ensure the use of quality; the use of large-scale medical equipment for a long period of time, should be used to establish the use of files, records of its use, maintenance, transfer, the actual use of time and other matters. Record-keeping period shall not be less than five years after the termination of the specified period of use of medical devices. Article 37 of the medical device user shall properly save the purchase of Class III medical devices of the original information, and to ensure that the information is traceable. The use of large medical devices and implantable and interventional medical devices, should be the name of the medical device, key technical parameters and other information, as well as the use of quality and safety closely related to the necessary information recorded in the medical record and other relevant records. /baike.baidu.com/item/%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0/883406?fr=aladdin#3 "target="_blank "title="Baidu Encyclopedia-Medical Devices">Baidu Encyclopedia-Medical Devices Medical Devices