1, basic surgical instruments Microsurgical instruments
2, neurosurgery surgical instruments ophthalmic surgical instruments
3. Otolaryngology surgical instruments and oral surgical instruments
4. Chest cardiovascular surgical instruments and abdominal surgical instruments
5, urinary anorectal surgical instruments orthopedic (orthopedic) surgical instruments
6, obstetrics and gynecology surgical instruments, family planning surgical instruments
7, injection puncture instrument burn (plastic) surgical instruments
8 general diagnostic instruments, medical electronic instruments and equipment
9 medical optical instruments, instruments and endoscopic equipment, medical ultrasonic instruments and related equipment
10, medical laser equipment, medical high-frequency equipment
1 1, physiotherapy and rehabilitation equipment, traditional Chinese medicine equipment
12 medical magnetic vibration equipment medical x-ray equipment
13 medical x-ray accessory equipment and components medical high-energy x-ray equipment
14, medical radionuclide equipment, medical radiation protection articles and devices
15, clinical inspection and analysis instruments, medical laboratories and basic equipment and appliances
16, Implant materials and artificial organs for cardiopulmonary bypass and blood treatment equipment.
17, operating room, emergency room, clinic equipment and appliances, dental equipment and appliances
18, ward nursing equipment and utensils disinfection and sterilization equipment and utensils
19, medical cold therapy, low temperature, oral materials for refrigeration equipment and appliances.
20 medical hygiene materials and dressings, medical suture materials and adhesives
2 1, interventional equipment for medical polymer materials and products
Extended data:
(1) Medical device filing means that the food and drug supervision and administration department files the filing materials of Class I medical devices submitted by medical device filers (hereinafter referred to as filers) for future reference.
(2) The medical devices for filing are Class I medical devices in the Catalogue of Class I Medical Devices and the corresponding in-vitro diagnostic reagent classification subdirectories.
For the filing of Class I medical devices in China, the filing person shall submit the filing materials to the municipal food and drug supervision and administration department with districts. For the record-keeping of imported medical devices of Class I, the record-keeping person shall submit the record-keeping materials to China Food and Drug Administration. The filing of medical devices in Hongkong, Macau and Taiwan Province shall be handled with reference to imported medical devices.
(3) The registered imported medical devices shall obtain the marketing permission of medical devices in the country (region) where the registrant is registered or the place where the production address is located.
If the product is not managed as a medical device in the country (region) where the registrant is registered or the country (region) where the production address is located, the registrant shall provide relevant certification documents, including certification documents that the country (region) where the registrant is registered or the country (region) where the production address is located allows the product to be legally listed.
(4) Overseas filers shall handle the filing of imported medical devices through their representative offices established in China or designated domestic legal person enterprises as agents.
(five) the filing person shall prepare the product technical requirements for the medical devices to be filed. The technical requirements of products mainly include the performance indexes and inspection methods of finished medical devices.
(6) When filing medical devices, the filer shall submit the filing materials according to the relevant requirements (see Annex 1) and be responsible for the authenticity, completeness and compliance of the filing materials.
(seven) if the filing materials meet the requirements, the food and drug supervision and administration department shall release them on the spot. If the filing materials are incomplete or do not conform to the prescribed form, it shall inform all the contents that need to be corrected at one time. If it is not filed, it shall inform the filer and explain the reasons.
(eight) for medical devices that need to be filed, the food and drug supervision and administration department shall make a filing certificate (see Annex 2) in the format required by relevant regulations, and publish the information published in the filing information table (see Annex 3) on its website. The food and drug supervision and administration department shall carry out the filing work in accordance with the Code of Practice for the Filing of Class I Medical Devices (see Annex 4). The filer shall mark the record number on the instructions and labels of medical devices.
(9) If the contents published in the filing information form and the technical requirements of the medical devices that have been filed change, the filer shall submit the explanation of the change and relevant supporting documents, and submit the information of the change to the original filing department. If the food and drug supervision and administration department meets the formal requirements for the filing materials, it shall indicate the changes in the change column and file the filing materials.
Baidu Encyclopedia _ A Class of Medical Devices