The State Food and Drug Administration adjusts some contents of the "Medical Device Classification Catalog"

In order to further deepen the reform of the medical device review and approval system, according to the actual development of the medical device industry and supervision work, and in accordance with the relevant requirements of the "Regulations on the Supervision and Administration of Medical Devices" and the "Working Procedures for Dynamic Adjustment of the Classification of Medical Devices", the State Food and Drug Administration Part of the content of the "Device Classification Catalog" has been adjusted
.
Relevant matters are hereby announced as follows: 1.
Adjustment content Adjustments are made to the contents of the "Medical Device Classification Catalog" for 10 medical device products such as clip devices on 02-15-14, and the specific adjustment content is shown in the attachment
.
2.
Implementation requirements (1) For the "14-10-08 liquid dressings and paste dressings" that are adjusted from category I to category II in the annex, they are provided non-sterilely and form a protective layer on the surface of the wound to act as a physical barrier.
, liquid dressings and paste dressing products used for the care of superficial wounds such as small wounds, abrasions, incisions and the surrounding skin, from the date of this announcement, can be implemented in accordance with the "Administrative Measures for Registration and Filing of Medical Devices" (Order No.
47 of the State Administration for Market Regulation) to apply for registration
.
Before January 1, 2022, the first-class medical device product filing according to the 2017 version of the "Medical Device Classification Catalog" will continue to be valid before April 1, 2023; from April 1, 2023, such products have not been registered.
The medical device registration certificate obtained in accordance with the law shall not be produced, imported or sold
.
Relevant production enterprises should effectively implement the main responsibility for product quality and safety to ensure the safety and effectiveness of listed products
.
(2) For other products whose contents have been adjusted, from the date of this announcement, the drug regulatory authorities shall, in accordance with the Measures for the Administration of Medical Device Registration and Filing, and the Announcement on the Announcement of Medical Device Registration Application Materials Requirements and Approval Document Formats, etc.
, and accept medical device registration applications according to the adjusted categories
.
For medical devices that have been accepted but have not yet completed registration approval (including initial registration and renewal registration), the drug regulatory department will continue to review and approve according to the original acceptance category.
If registration is approved, a medical device registration certificate will be issued, and it will be indicated in the remarks column of the registration certificate.
Adjusted Product Stewardship Category
.
For a registered medical device whose management category is adjusted from Class III to Class II, the medical device registration certificate will continue to be valid within the validity period
.
If renewal is required, the registrant shall apply to the corresponding drug regulatory department for renewal of registration according to the changed category 6 months before the expiration of the medical device registration certificate.
Registration certificate
.
If a registration change occurs within the validity period of the medical device registration certificate, the registrant shall apply to the original registration department for registration change
.
If the original registration certificate is issued in accordance with the original "Medical Device Classification Catalog", the product management category after the implementation of the announcement shall be indicated in the remarks column of the registration change document of the product involved in this announcement
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(3) Drug supervision and administration departments at all levels should strengthen the publicity and training of the content adjustment of the "Medical Device Classification Catalog", and effectively do a good job in the review and approval and post-marketing supervision of related products
.
Special announcement
.
Attachment: Partial Content Adjustment Table No.
of "Medical Device Classification Catalog" Contents of "Medical Device Classification Catalog" after content adjustment Primary Product Category Secondary Product Category Product Description Intended Use Name Example Management Category 1 02 - Passive Surgical Instruments 15 - Surgical Instruments - Other Instruments 14 - Clips The device usually consists of an outer sheath, a rotating sheath, and a clip
.
The clip is generally made of stainless steel, and the retention time in the body is greater than or equal to 30 days
.
Supplied sterile
.
Used with endoscopes to place clips in the digestive tract
.
Clips are used for endoscopic marking, hemostasis of digestive tract tissue
.
Clip device Ⅲ 02-Passive surgical instruments 15-Surgical instruments-Other instruments 14-Clip device usually consists of an outer sheath, a rotating sheath and a clip
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The clips are generally made of stainless steel
.
Provided sterile
.
No change No change II 2 03-Neural and cardiovascular surgical instruments 13-Nerve and cardiovascular surgical instruments-cardiovascular interventional instruments Sponge, support silicone rubber, connecting tube and 70% isopropanol or ethanol aqueous solution
.
It is not only used for physical barrier infusion (injection) equipment needleless joints (including outer cone locking joints and inner cone locking joints); it is also used to sterilize the needleless joints of infusion (injection) instruments
.
Catheter sterilization connector, infusion connector sterilization cap Ⅲ 03-Neural and cardiovascular surgical instruments 13-Nerve and cardiovascular surgical instruments-cardiovascular interventional instruments 04 Catheter sterilization connector No change No change No change II 3 03-Nerve and cardiovascular Surgical Instruments 13 - Neural and Cardiovascular Surgical Instruments - Cardiovascular Interventional Instruments 12 - The puncture needle is usually a rigid tube with a sharp tip
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Used to introduce a guidewire or catheter into a blood vessel
.
Vascular Puncture Needle III 03-Neural and Cardiovascular Surgical Instruments 13-Nerve and Cardiovascular Surgical Instruments-Cardiovascular Interventional Instruments 12-Puncture Needle No Change No Change No Change II 4 03-Nerve and Cardiovascular Surgical Instruments 13-Nerve and Cardiovascular Vascular surgical instruments - cardiovascular interventional instruments 14 - The catheter sheath is usually composed of a sheath tube and a joint, and can also be equipped with a hemostatic valve, a side tube and other structures.
Some catheter sheaths are designed to be tearable
.
The lumen of the sheath is generally larger
.
Used in conjunction with dilators to insert medical devices such as guide wires and catheters into blood vessels
.
Introducer sheath, introducer sheath, arterial sheath, venous vascular sheath, micro-puncture vascular sheath, tear-type vascular sheath III No change No change No change II 5 03 - Neural and Cardiovascular Surgical Instruments 13 - Neural and Cardiovascular Surgical Instruments - Cardiovascular Interventional Instruments 15 - Dilators usually consist of a tube body and a joint
.
The tube body is generally thick and not easy to bend
.
The dilator tip is generally tapered
.
Supplied sterile
.
Flexible tubular device for dilation of percutaneous access and vascular access into blood vessels
.
Dilator III 03-Neural and Cardiovascular Surgical Instruments 13-Nerve and Cardiovascular Surgical Instruments-Cardiovascular Interventional Instruments 15-Dilator No Change No Change No Change II 6 03-Neural and Cardiovascular Surgical Instruments 13-Nerve and Cardiovascular Surgical Instruments - Cardiovascular Interventional Instruments 18 - Connection Valves typically have two or more ports that can be connected to catheters or other instruments that enter the blood vessel
.
It is used to connect pipelines and establish channels to assist instruments entering the human body, and at the same time, it can reduce blood outflow
.
Y-type connection valve III 03-Neural and cardiovascular surgical instruments 13-Nerve and cardiovascular surgical instruments-Cardiovascular interventional instruments 18-Connection valve no change no change no change II 7 03-neural and cardiovascular surgical instruments 13-nerve and Cardiovascular Surgical Instruments - Cardiovascular Interventional Instruments 25 - The extension tube is usually composed of a catheter, a joint, and an O-ring
.
Used for pipeline extension, drug infusion and rapid infusion in interventional surgery, etc.

.
High Pressure Contrast Injection Extension Tube III 03-Neural and Cardiovascular Surgical Instruments 13-Neural and Cardiovascular Surgical Instruments-Cardiovascular Interventional Instruments 25-Extension Tube No Change No Change No Change II 8 13-Passive Implantation Instrument 01-Bone Joint Implant 05 - Metal fixation cerclage usually consists of metal band, metal flat strip, or single or multi-strand wire, and may contain other accessories
.
It is generally made of pure titanium and titanium alloys, stainless steel, cobalt chromium molybdenum and other materials
.
Surrounding a long bone and anchoring to the long bone with wires or screws for fracture fixation
.
Metal cable/cable, flexible metal wire, metal cable/cable system III 13-Passive implant device 01-Bone engaging implant 05-Metal fixation cerclage device No change Anchored to bone by wire or screw, For bone fixation or bone joining
.
No change No change 9 13-Passive implant devices 09-Orthopedic and general surgical implants 02Orthopedic injectable filler Usually consists of a syringe and filler material pre-filled in the syringe
.
For injection into the dermis and/or subcutaneous tissue to increase tissue volume
.
Cross-linked sodium hyaluronate gel for injection, sodium hyaluronate gel for injection, collagen implant, poly-L-lactic acid filler for injection Ⅲ 13-Passive implant device 09-Plastic and general surgical implant 02No change in plastic injection filler No change Cross-linked sodium hyaluronate gel for injection, sodium hyaluronate gel for injection, collagen implant, poly-L-lactic acid filler for injection, recombinant type III humanized Collagen freeze-dried fibers unchanged 10 14-Infusion, care and protective equipment 10-Wound dressings 08-Liquid, paste dressings are usually solutions or ointments (excluding gels)
.
The contained ingredients do not have pharmacological effects
.
The ingredients contained are not absorbed by the human body
.
Supplied sterile
.
It acts as a physical barrier by forming a protective layer on the wound surface
.
It is used for the care of small wounds, abrasions, cuts and other non-chronic wounds and the surrounding skin
.
Sterile Liquid Dressings, Sterile Spray Dressings, Sterile Wound Care Ointments, Sterile Liquid Wound Dressings II 14-Infusion, Nursing and Protective Devices 10-Wound Dressings 08-Liquid and Paste Dressings are usually solutions or ointments (not including gel)
.
The contained ingredients do not have pharmacological effects
.
The ingredients contained are not absorbed by the human body
.
It acts as a physical barrier by forming a protective layer on the wound surface
.
For the care of non-chronic wounds and surrounding skin such as small wounds, abrasions and cuts
.
Sterile Liquid Dressings, Sterile Spray Dressings, Sterile Wound Care Ointments, Sterile Liquid Wound Dressings, Liquid Dressings, Spray Dressings, Wound Care Ointments, Liquid Wound Dressings II Usually solutions or ointments (excluding gels)
.
The contained ingredients do not have pharmacological effects
.
The ingredients contained are not absorbed by the human body
.
Supplied non-sterile
.
It acts as a physical barrier by forming a protective layer on the wound surface
.
It is used for the care of superficial wounds such as small wounds, abrasions and cuts and the surrounding skin
.
Liquid dressing, spray dressing, wound care ointment, liquid wound dressing Ⅰ State Food and Drug Administration March 22, 2022