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| New catalogs have been issued, and these categories have changed |
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| Author：中国铭铉 企划部 Release Time：2017-9-5 11:46:36 Number Browse：822 |
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A new catalogue of medical devices, revised by the general administration of medicine, has been released and will take effect from August 1, 2018.
The new edition is a big change from the 2002 edition: a 43-person directory is reduced to 22. Increased product expectations and product descriptions; For example, the product name has been expanded from 1008 to 66609.
For the industry, the core of the focus is: the management categories of dozens of medical devices have declined, from three to two, and from the second to the second. Some products are promoted. Other products will no longer be managed as medical devices.
Product category is to directly affect the changes in medical device manufacturing enterprise, such as manufacturers, their products are three kinds of originally, reduced to 2 kinds of management, the enterprise will be no need to run to Beijing, to the administration of drug safety for product registration, just sign up in this province food and drug administration.
From the second class to the management, the production enterprises are more convenient, the products do not need to register, only the record can be.
After dropping the class, the registration fee will be saved in addition to the registration. With three kinds of reduced to the second class, for example, three kinds of products for the first time in the original registration charge 153600 yuan, and go to the place after registered, now is the cheapest in ningxia only 31300 yuan, more than 10 provinces and haven't started to charge.
, of course, in turn, for rose products, registered to some trouble than they are now, by the second class for three categories, risk level, will face more rigorous and intensive drug safety supervision measures.
Overall, the new edition of the catalog is still relatively large. To this end, the administration of drug administration has also given medical device regulators and the production, operation and use of the unit for a certain period of digestion.
How to make a transition? During the transition period enterprise registration application how to do? Please refer to the general administration's notice concerning the implementation of the classification catalogue of medical devices (no. 143 of 2017), which can be found on CFDA website.
Is your product category ownership changing?
The following is a list of health products for cypress blue equipment:
1. Infusion pumps for radiofrequency ablation devices, the category of management is reduced to category 2 by category 3.
2. Light-emitting diode (LED) operation lighting, from the second category to the first.
3, "automatic immunity analyzer", including "automatic enzyme-linked immunity analyzer", "automatic chemiluminescence immune analyzer", "automatic fluorescence immunoassay analyzer," by the third class to the second class.
4. Microbiological identification drug sensitive analysis instrument and microorganism drug sensitive culture monitoring instrument, the third category of health is the second type.
5. Washing machine, the second type is reduced to the first category.
6. The X-ray image processing system, nuclear medical imaging and medical magnetic resonance imaging system of the "6870-2 diagnostic image processing software" of the classified catalogue of the 2002 edition are the second category.
7. Desensitizing products, the third category is the second category.
8. Silver amalgam alloy is the second type of mercury.
9. In the original classification catalog of 2002, there are clear classification of the working tips of the cleaning teeth and the only ones used for polishing and polishing, and the second category is the first category.
10. Orthodontic spring, the first category is the second type.
11. The implant sealing material was reduced by category 3 to category 2.
12. Periodontal treatment of periodontal, which is the second category of the third category.
13. Floss powder, which falls from the third category to the second category.
14. The root canal enlarging fluid and the root canal cleaning agent, the third category is the second type.
15. Temporary crown bridge resin, the third category falls into the second category.
16. Dental peduncle, the second category is the first category.
17. The use of biopsy needles at once was reduced to the second type by category 3.
18. The foot separation supplies, the isolation shield, from the second category to the first category.
19. Contact with the thoracic cavity, abdominal cavity, ventricle, lumbar spine, inner surface of the wound or surface of the surface of the skin deep and the following tissue surface drainage guide, from the third category to the second category.
20, pocket (including colostomy chassis), chassis, after colostomy care supplies, colostomy bolt, leakproof, colostomy skin care powder, colostomy skin protectant colostomy care products, such as by the second class to first class.
The third type of the ilium puncture needle is the second type.
22. For non-chronic wound surface, contact with the deep layer of the dermis and the following tissues, which are not absorbed by the human body, the third category falls into the second category.
23. Iodine liquid protective cap, which falls from category 3 to category 2.
24. Gastrointestinal radiographic imaging agents in gastrointestinal X-ray examination products were reduced by category 3 to category 2.
25. Gastrointestinal ultrasonography powder was reduced from category 3 to category 2.
The radionuclide scanning device is the second class of the third type.
The endoscope airbag controller is the second type of the third type.
28. Medical optical amplifiers with LED light source, from category 2 to category 1.
29. The non-sterile supply of orthopedics provided by the non-aseptic delivery of the intervertebral intervertebral disc has been used in the first class.
The opening of a cone (eg, a hand cone) is reduced to the first category by the second type.
31, may contact the central nervous system in the operation of sterile orthopedic chisel, in orthopaedics in file, and bone with a shovel, spine positioning/guide/measuring instruments, spine hole reaming instrument, spine nerve root spies, spine bone graft of embedded device, spine pedicle screw tail cutter, spinal surgery instrument, spine vertebra reset device, orthopedic stripping protector, orthopaedic group protection devices, by the second class to first class.
Products involved in classification adjustment and normative management include:
1. Patella claw, specification is the third kind of management.
2. Automatic blood bank system, which is the third type of management.
3. Ophthalmic laser optical fiber, the management category specification is the third category.
4. Optical positioning guidance system, unified standard is the third type of medical device management.
5. Active respiratory control system, adjusted for the third type of medical equipment management.
6. Catheter sterilization connector, according to the third type of medical device management.
7. Cerebral depressor, the first type is adjusted to the second type.
8. Cardiovascular surgery or brain surgery, the regulation is the second type of management. For example, the brain attractor is promoted from one class to the second.
9. The bone marrow suction and biopsy system electric drill, the specification is the second type of management.
19, with active devices (such as electric drill, electric saw, pneumatic bone bone bone drill) connection using the drill bit, cutter, blade, enlarge pulp machine, cutter, grinding the top supporting tools, specification for the first category management.
12. Oral cavity instruments:
Metal and ceramic materials are made of solid piles, and the management category is the second type.
The abrasive material is used for the second type of management in the mouth and the first type of management.
Denture trial materials, such as test paste products, are the first category of management category.
Occlusive relationship record/inspection material, in accordance with the first type of management.
Substitute body, as medical device management, management category is a category.
13. Diagnostic function software, if it only has the auxiliary diagnostic function, does not directly give the diagnosis conclusion, according to the second type of medical device management. If through its algorithm (for example, CAD, bone mineral density except) to automatic identification of pathological changes, and provides the definite diagnosis, is its relatively high level of risk, according to the third category of medical equipment management.
14. It contains alcohol, iodine tincture or iodide, and is only used for the clinical application of complete skin disinfection and liquid absorbing materials, and the second type of medical device management.
15. Hydraulic transmission device, the carrying instrument with hydraulic function is managed according to the second type of medical device, and the hydraulic function is not controlled by the first type of medical instrument.
16. Test frame, not as medical device management.
17. The syringe is used in piston, not according to medical device management.
18. Infusion bottle stickers, not according to medical device management.
19. The infusion workstation shall not be managed according to medical devices.
20. The product containing disinfectant (antimicrobial agent) is not regulated according to medical devices.
21. The radiotherapy patient's bed plate is not managed separately by medical device.
22. Medical information management software, if it is only hospital management tool, management content is patient information and other non-medical diagnosis and/or treatment content, not according to medical device management.
23. Remote medical consultation system software, if it does not include medical images or data, does not follow medical device management.
24. Related to the clinical test, but the product itself does not have the function of medical device, not according to medical device management. Liquid such as: move, pipette, common reaction, reaction tube, plate, regular sampling cup, sampling tube, sample collector, in clinical laboratory for testing samples before/after transmission, add/to cover, such as bar code identification function of the sample management system, etc.
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