The first class of medical devices does not need to be filed.
The operation of Class I medical devices do not need to be filed, the "supervision and management of medical devices business approach" Article IV:
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.
Enterprises engaged in the third class of medical devices business should also have to meet the requirements of quality management of medical devices business computer information management system to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management of medical equipment business in line with the requirements of the computer information management system.
The Measures for the Supervision and Administration of Medical Device Operation are formulated to strengthen the supervision and administration of medical device operation, standardize the behavior of medical device operation, and ensure the safety and efficacy of medical devices in accordance with the Regulations for the Supervision and Administration of Medical Devices. Issued by the State Food and Drug Administration on July 30, 2014, since October 1, 2014 shall come into force.
Expanded Information
Class I medical devices include:
Basic Surgical InstrumentsMicrosurgical Instruments
Neurosurgical InstrumentsOphthalmic Surgical Instruments
Otorhinolaryngology Surgical InstrumentsOrthodontic Surgical Instruments
Thoracic and Cardiovascular Surgical InstrumentsAbdominal Surgical Instruments
Urinary and Anorectal Surgical InstrumentsOrthopedic Surgical Instruments
Obstetrics and Gynecology Surgical InstrumentsFamily Planning Surgical Instruments
Injectable and Puncture InstrumentsBurns (Orthopedic) Surgical Instruments
General Diagnostic InstrumentsMedical Electronic Instruments and Equipment
Medical Optical Apparatus, Instruments and Endoscopic EquipmentMedical Ultrasound Instruments and related equipment
Medical laser instruments and equipment medical high-frequency instruments and equipment
Physical therapy and rehabilitation equipment Chinese medicine instruments
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 instruments
Clinical testing and analysis instruments medical laboratory and basic equipment and apparatus
Extracorporeal circulation and blood processing equipment implantable materials and artificial organs
Operating room, emergency room, diagnostic and treatment room equipment and apparatus stomatology equipment and apparatus
Ward care equipment and apparatus sterilization and disinfection equipment and apparatus
Medical cold therapy, cryogenic, refrigeration equipment and apparatus stomatology Materials
Medical hygiene materials and dressings medical suture materials and adhesives
Medical polymer materials and products interventional devices
Baidu Encyclopedia--Medical Devices Management Supervision and Administration