Class I medical devices do not need a license. According to the "supervision and management of medical devices business approach" Chapter I, Article 4: According to 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.
Basic surgical instrumentsMicrosurgical instruments
Neurosurgical instrumentsOphthalmic surgical instruments
Otorhinolaryngology surgical instrumentsOral surgical instruments
Thoracic and cardiovascular surgical instrumentsAbdominal surgical instruments
Urological and anorectal surgical instrumentsArthopaedic (orthopaedics)surgical instruments
Injection and Puncture Instruments Surgical Instruments for Burns (Plastic) Surgical Instruments
General Diagnostic Instruments Medical Electronic Instruments and Equipment
Medical Optical Apparatus, Instruments, and Endoscopic Devices Medical Ultrasonic Instruments and Related Devices
Medical Laser Instrumentation and Equipment Medical High-frequency Instrumentation and Equipment
Physical Treatment and Rehabilitation equipment and instruments for traditional Chinese medicine
Medical magnetic **** vibration equipment medical X-ray equipment
Medical X-ray accessory equipment and components medical high-energy radiation equipment
Medical nuclide equipment medical ray protection supplies, devices
Clinical test and analysis instruments medical laboratory and basic equipment and apparatus
Extracorporeal circulation and blood processing equipment implanted materials and artificial organs and artificial organs
Operating room, emergency room, diagnostic and treatment room equipment and appliances stomatology equipment and appliances
Ward care equipment and appliances Disinfecting and sterilizing equipment and appliances
Medical cold therapy, cryotherapy, refrigeration equipment and appliances stomatology materials
Medical hygienic materials and dressings for medical suture materials and adhesives
Medical polymer material and Products interventional devices
The first category is a low degree of risk, the implementation of routine management can ensure its safety, effective medical devices.
Medical device license permit requirements: 1 with the scope and scale of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles; 2 with the scope and scale of operation of the business, storage space.
Legal basis: "supervision and management of medical devices business approach" Article VII engaged in the operation of medical devices, should have the following conditions: (a) with the scope of business and business scale appropriate quality management organization or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles; (b) with the scope of business and business scale appropriate business, Storage place; (c) with the scope of business and business scale appropriate storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse; (d) with the operation of medical devices compatible with the quality management system; (e) with the operation of medical devices compatible with the professional guidance, technical training and after-sales service capabilities, or agreed to provide technical support by the relevant organizations. Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the quality management requirements for the operation of medical devices to ensure that the products operated can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish in line with the quality of medical equipment business management requirements of the computer information management system.