Medical Devices Classification Catalog:
1, Basic Surgical InstrumentsMicrosurgical Instruments
2, Neurosurgical InstrumentsOphthalmic Surgical Instruments
3, Ear, Nose, and Throat Surgical InstrumentsOral Surgical Instruments
4, Thoracic and Cardiovascular Surgical InstrumentsAbdominal Surgical Instruments
5, Urologic and Anesthesiologi Surgical Instruments Orthopedic Surgical Instruments
6, Surgical Instruments for Obstetrics and Gynecology Surgical Instruments Family Planning Surgical Instruments
7, Injection and Puncture Instruments Surgical Instruments for Burns (Orthopedics)
8, General Diagnostic Instruments Medical Electronic Instruments and Equipment
9, Medical Optical Apparatus, Instruments, and Endoscopic Devices Ultrasound Instruments for Medical Purposes and Related Equipment
10, medical laser instruments and equipment, medical high-frequency instruments and equipment
11, physical therapy and rehabilitation equipment, Chinese medicine instruments
12, medical magnetic **** vibration equipment, medical X-ray equipment
13, medical X-ray accessory equipment and components, medical high-energy radiation equipment
14, medical nuclide equipment, medical ray protection supplies, devices
14, medical nuclide equipment, medical ray protection supplies, devices
14, medical nuclide equipment, medical ray protection supplies, devices
15, clinical laboratory and analytical instruments for medical laboratory and basic equipment and apparatus
16, extracorporeal circulation and blood processing equipment, implantable materials and artificial organs
17, operating room, emergency room, diagnostic and therapeutic room equipment and appliances, stomatology equipment and appliances
18, ward care equipment and appliances, sterilization and disinfection equipment and appliances
19, medical cold therapy, cryotherapy, low-temperature, medical radiation protection supplies and devices
19 Medical cold therapy, low temperature, cold storage equipment and appliances stomatology materials
20, medical hygiene materials and dressings medical suture materials and adhesives
21, medical polymer materials and products interventional devices
Extended information:
(a) Medical device filing refers to the food and drug administration department of the medical device The filer (hereinafter referred to as the filer) to submit the first class of medical devices for the record information on file for inspection.
(b) the implementation of the record of medical devices for the first class of medical devices catalog and the corresponding in vitro diagnostic reagents classified subdirectory of Class I medical devices.
Domestic Class I medical device filing, the filing of municipal food and drug supervision and management departments to submit the record information. Imported Class I medical devices for the record, the filer to the State Food and Drug Administration to submit the record information. Hong Kong, Macao, Taiwan medical equipment for the record, with reference to the import of medical devices.
(C) for the record of imported medical devices, should be filed in the filer's place of registration or production address in the country (region) to obtain marketing authorization for medical devices.
The filer's place of registration or production address in the country (region) is not the product as a medical device management, the filer is required to provide relevant documents, including the filer's place of registration or production address in the country (region) to authorize the product is legally listed on the market for sale of documents.
(d) overseas filers for the record of imported medical devices, should be set up in China through its representative organization or designate the Chinese territory of the enterprise as an agent for the legal person.
(E) the filer shall prepare to record the medical device product technical requirements. Product technical requirements mainly include performance indicators and test methods for finished medical devices.
(F) for the record of medical devices, the filer should be in accordance with the relevant requirements (see Annex 1) to submit the filing information, and the filing of information on the authenticity of the authenticity, completeness, compliance is responsible.
(vii) the filing information meets the requirements, the food and drug supervision and management department shall be filed on the spot. Record information is incomplete or does not meet the required form, it should be informed of the need to make corrections to all the contents. Not for the record, should inform the filer and explain the reasons.
(viii) to be filed for medical devices, food and drug supervision and management departments should be in accordance with the relevant requirements of the format of the record voucher (see Annex 2), and will be filed in the information table (see Annex 3) in the information contained in its website to be published. Food and drug supervision and management department in accordance with the first class medical device filing operation specification (see Annex 4) to carry out the filing work. The filer shall mark the filing number in the instructions and labeling of medical devices.
(ix) has been filed medical devices, filing information on the content of the table and the filing of the product technical requirements for the record changes, the filer should be submitted to the change in the description of the situation and the relevant documents, to the original filing department to change the filing information. Food and drug supervision and management department of the filing information in line with the formal requirements, should be set out in the change of circumstances in the change of circumstances, the filing information will be archived.
Baidu Encyclopedia_Class I Medical Devices