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Announcement on the Third Batch of Implementation of Unique Identification of Medical Devices (Draft for Comments)

 Last Update: 2023-01-01
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In order to further implement the Regulations on the Supervision and Administration of Medical Devices, the Notice of the General Office of the State Council on Printing and Distributing the Reform Plan for the Governance of High-value Medical Consumables, and the key tasks of the State Council to deepen the reform of the medical and health system, and promote the connection and application of unique identification of medical devices in the fields of supervision, medical treatment, medical insurance and other fields, the State Food and Drug Administration organized and drafted the "Announcement on Doing a Good Job in the Third Batch of Implementation of Unique Identification of Medical Devices (Draft for Comments)" (see annex), which is now open for comments
。 Please send your comments and suggestions to the email address before December 30, 2022: mdct@nmpa.
gov.
cn, indicating "UDI Third Batch Implementation"
by email.
Contact person and telephone: Dong Qian, 010-88330608
.
Annex: Announcement on the Third Batch of Implementation of Unique Identification of Medical Devices (Draft for Comments) General Department of the State Food and Drug Administration November 29, 2022 Announcement on the Third Batch of Implementation of Unique Identification of Medical Devices (Draft for Comments) On January 1, 2021, the first batch of 69 varieties in 9 categories began to implement the unique identification
of medical devices.
On June 1, 2022, other Class III medical devices (including in vitro diagnostic reagents) were fully identified as the second batch of implemented varieties
.
In order to further implement the Regulations on the Supervision and Administration of Medical Devices, the Notice of the General Office of the State Council on Printing and Distributing the Reform Plan for the Treatment of High-value Medical Consumables and the key tasks related to the State Council's deepening of the reform of the medical and health system, the third batch of medical devices will be implemented The announcement of matters related to the unique identification work is as follows: 1.
Variety range According to the degree of risk and regulatory needs, some single-use products with large clinical demand, varieties included in the scope of medical insurance centralized procurement, medical cosmetology-related products and other Class II medical devices are determined as the unique identification implementation varieties of the third batch of medical devices, and the specific product catalog is shown in the annex
。 2.
Schedule For medical devices included in the third batch of implementation product catalogs, the registrant shall carry out the following work in an orderly manner in accordance with the time limit requirements: (1) Unique identification and coding Medical devices produced from June 1, 2024 onwards shall have a unique identification of the medical device; The third batch of products that have been produced before that implement unique identification may not have unique identification
.
The date of manufacture is subject to the label of the medical device
.
(2) Unique identification registration system submission If the applicant applies for registration from June 1, 2024, the registration applicant shall submit the product identification of the smallest sales unit in the registration management system; If the registration has been accepted or approved before June 1, 2024, the registrant shall submit the product identification
of its smallest sales unit in the registration management system when the product registration is renewed or the registration is changed.
Product identification is not a matter for registration review, and a separate change of product identification does not fall within the scope of
registration change.
(3) Uniquely identify database submissions In the case of medical devices produced from June 1, 2024, before they are put on sale, the registrant shall upload the product identification and related data of the smallest sales unit and higher-level packaging to the unique identification database of the medical device in accordance with the requirements of relevant standards or specifications to ensure that the data is true, accurate, complete and traceable
。 For medical devices that have maintained information in the medical insurance medical consumables classification and code database of the National Medical Insurance Administration, it is necessary to supplement and improve the medical insurance medical consumables classification and code fields in the unique identification database, and at the same time improve the information related to the unique identification of medical devices in the maintenance of the medical insurance medical consumables classification and code database, and confirm the consistency
with the data in the unique identification database of medical devices.
When the data related to the product identification of the minimum sales unit of a medical device changes, the registrant shall make the change in the unique identification database of the medical device before the product is put on the market to achieve data updating
.
When the product identification of the minimum sales unit of a medical device changes, the data
shall be uploaded in the unique identification database of the medical device in accordance with the newly added product identification.
3.
Relevant requirements Medical device registrants should earnestly implement their main responsibilities, encourage the establishment and improvement of traceability systems based on unique identification, and do a good job in product recall, tracking and tracing
.
For changes in the product management category due to the dynamic adjustment of the Classification Catalogue of Medical Devices, the medical device registrant shall implement a unique identification
in accordance with the requirements of the adjusted management category.
Medical device trading enterprises should actively apply unique identification in business activities, do a good job of entering and leaving the warehouse with codes, and realize the traceability
of products in the circulation link.
Medical institutions should actively apply unique identification in clinical practice such as clinical use, payment and charging, settlement and reimbursement, and do a good job of coding records throughout the process to achieve product traceability
in clinical links.
Code-issuing institutions should formulate standards and guidelines for the compilation of unique identifiers for their own institutions, guide medical device registrants to carry out the creation and coding of unique identifiers, and verify the readability
of unique identifiers prepared in accordance with their standards in circulation and use.
Provincial-level drug regulatory departments should strengthen training and guidance on unique identification work, do a good job in transforming the product registration system in combination with the needs of implementation work to promote it, organize medical device registrants in their jurisdictions to carry out product coding, data upload and maintenance work as required, strengthen coordination with health and medical insurance departments in their jurisdiction, and promote the linkage
of the three doctors.
Provincial-level health departments should guide medical institutions within their jurisdictions to actively apply unique identifiers and strengthen the standardized management
of medical devices in clinical applications.
Provincial-level medical insurance departments should strengthen the classification and code of medical insurance medical consumables and the use of the unique identification of medical devices, and promote the transparency and intelligence
of catalog access, payment management, and volume bidding.
This is hereby announced
.
Attached: The third batch of product catalogs that implement the unique identification of medical devices The third batch of product catalogs that implement the unique identification of medical devices According to the "Medical Device Classification Catalogue", the following varieties (141) are listed: 1.
01 Active surgical instruments

Tier 1 product category	Secondary product categories	Manage categories
01Ultrasound surgery equipment and accessories	03Ultrasound surgery equipment accessories	II
02Laser surgery equipment and accessories	02Medical laser fiber	II
03High-frequency/radiofrequency surgical equipment and accessories	01High-frequency surgical equipment	Class II section
	03Argon protective aerocoagulation equipment	II
	04Electrodes and catheters for high frequency/radio frequency	Class II section
	05Perfusion pump for RF ablation equipment	II
09Active for endoscopic surgery equipment	01Active equipment for endoscopic surgery	II
10 Other surgical equipment	Electric stapler	II
10 Other surgical equipment	04 Surgical power system	II

2.
02 passive surgical instruments

Tier 1 product category	Secondary product categories	Manage categories
01 Surgical instruments - knives	05 Endoscope knife	II
03 Surgical instruments - scissors	03 Endoscope with scissors	II
04 Surgical instruments - forceps	09 Tissue forceps for endoscope	II
	10 sampling forceps for endoscopes	II
	11 Separation forceps for endoscopes	II
	12 foreign object forceps for endoscopes	II
	13 Instrument forceps for endoscopes	II
07 Surgical instruments - needles	04 Endoscopic sampling needle	II
08 Surgical instruments - hooks	02 Hook for endoscope	II
09 Surgical instruments - curettes	02 Tissue curette for endoscopy	II
10 surgical instruments - strippers	02Stripper for endoscopes	II
11 Surgical instruments - retractors	04Retractor for endoscope	II
11 Surgical instruments - retractors	05 Airbag dilator for endoscope	II
12 Surgical Instruments- Puncture guide	05Endoscope guide	II
13. Surgical instruments - snout (suture) instruments and materials	01 Stapler (with nails)	Class II section
	02 Stapler (without nails)	Class II section
	03Endoscopic snout (suture) instrument (without nails)	II
	04 Vascular suture device	Class II section
	07 Non-absorbable sutures	II
15 Surgical instruments - other instruments	16 Pusher for endoscopes	II
	17 endoscopes with a cell brush	II
	18 Stone removal instruments for endoscopes	II
	19 Endoscopic incision retracts the protector	II
	20 lithotomy balloon catheters for endoscopes	II
	21 balloon catheters for endoscopes	II
	22 Endoscope feeder	II
	23 Endoscopes with bands	II

3.
03 Instruments for neurological and cardiovascular surgery

Tier 1 product category	Secondary product categories	Manage categories
10 Instruments for nerve and cardiovascular surgery - retractors	03 Expander	II
11 Instruments for Neurological and Cardiovascular Surgery - Puncture Guides	01 Hole punch	Class II section
12 Instruments for Nerve and Cardiovascular Surgery - Flush Aspirator	01 Flusher	II
	02 Pass Article	II
13 Instruments for Nerve and Cardiovascular Surgery - Cardiovascular Interventional Instruments	04Catheter sterilization connector	II
	12 puncture needles	II
	14 ductal sheaths	II
	15 dilators	II
	17 balloon compression device for balloon dilation catheter	II
	18 connection valve	II
	25 extension tubes	II

4.
04 Orthopedic surgical instruments

Tier 1 product category	Secondary product categories	Manage categories
01 Orthopedic knife	02 Orthopedic endoscopic knife	II
02 Orthopedic scissors	01 Orthopedic endoscopic scissors	II
03 Orthopedic forceps	01 Orthopedic endoscopic forceps	II
05 Orthopedic needles	02 Traction pin	Class II section
06 Orthopedic scraping	01 Curette for orthopedic endoscopy	II
07 Cone for orthopedics	01 Bone cone for interventional surgery	II
12 Active instruments for orthopedics	01 Orthopedic power surgery equipment	II
12 Active instruments for orthopedics	02Supporting tools	Class II section
13. External fixation and traction equipment	02External fixation bracket	Class II section
14. Basic universal assistive devices	01 Minimally invasive bone guide	II
	02 Bone cement instruments	Class II section
	03 Bone grafting instruments	Class II section
16 Joint Surgery Auxiliary Instruments	01 Bone cement shaping mold	Class II section
16 Joint Surgery Auxiliary Instruments	02Arthroscopic tools	II
17 Auxiliary instruments for spine surgery	03 Injection propulsion device	Class II section
	04Verteplasty guidance system	II
	05 Fiber ring suture instrument	II
	06 Vertebral posterior edge processor	II
	13 spinal surgery access instruments	II
	15 supporting tools	Class II section
18 Orthopedic other surgical instruments	01 Stripper	Class II section
18 Orthopedic other surgical instruments	02 Skull orthopedic instruments	II

5.
06 Medical imaging equipment

Tier <> product category	Secondary product categories	Manage categories
01 Diagnostic X-ray machine	02 Urinary X-ray machine	II
01 Diagnostic X-ray machine	04 Oral X-ray machine	Class II section
14 medical endoscopes	01 Optical endoscope	II
14 medical endoscopes	03 Electronic endoscope	II
16 endoscopic accessories	06 Biopsy bag for endoscopy	II
16 endoscopic accessories	07 Endoscopic bite, cannula	Class II section

6.
07 Medical examination and monitoring equipment

Tier <> product category	Secondary product categories	Manage categories
10. Accessories, consumables	03 Body surface electrodes	II
	04 Pulse oximeter	II
	05 Conductive paste	II

7.
08 Respiration, anesthesia and first aid equipment

Tier <> product category	Secondary product categories	Manage categories
05 Respiratory, anesthesia, first-aid equipment auxiliary devices	06 Laryngoscope for endotracheal intubation	II
	07 Atomization equipment / atomization device	II
06 Breathing and anesthesia tubes, masks	03 Endotracheal intubation/tracheal cannula	II
	04 Esophageal tracheal intubation	II
	05 Laryngeal mask	II
	06 Oropharyngeal / nasopharyngeal airway	II
	07 Bronchial blocker	II
	08 nasal oxygen tube	Class II section
	09 Suction catheters for the respiratory tract (suction tube)	II

8.
09 Physical therapy equipment

Tier <> product category	Secondary product categories	Manage categories
03 Light therapy equipment	01 Laser treatment equipment	Class II section
	02 Photodynamic laser treatment equipment	Class II section
	04 Intense pulsed light therapy equipment	II
	05 Red light therapy equipment	II
	06 Blue light treatment equipment	II

9.
10 Blood transfusion, dialysis and cardiopulmonary bypass instruments

Tier <> product category	Secondary product categories	Manage categories
03Blood purification and peritoneal dialysis equipment	06 peritoneal dialysis equipment	II
04 Blood purification and peritoneal dialysis equipment	04 Peritoneal dialysis equipment	Class II section

10.
12 Active implantation devices

Tier <> product category	Secondary product categories	Manage categories
01Cardiac rhythm management equipment	10 pacing system analysis equipment	II
	11. Cardiac rhythm management program-controlled equipment	II
	12 connector sleeves	II
02 Neuromodulation equipment	07Test stimulator	II
	08Test the extension wire	II
	09 Neural regulation program-controlled equipment	II
03 Assistive bit hearing device	02 External sound processor	II
03 Assistive bit hearing device	03 Auxiliary position hearing control equipment	II
04 Others	01 Implantable cardiac contractility Adjust the device	Class II section

11.
14 Infusion, nursing and protective equipment

Tier <> product category	Secondary product categories	Manage categories
01Injection and puncture instruments	01 Syringe pump	Class II section
	04 pen injectors	II
	07 Syringe auxiliary pushing device	Class II section
	08 Puncture instruments	II
	09 Biopsy needle	II
02 Intravascular infusion equipment	01 Infusion pump	Class II section
02 Intravascular infusion equipment	12. Transfer and dispensing equipment for drug liquid	II
05 Non-endovascular catheter	02 Transnasoenteral nutrition catheter	II
	03 urinary catheter	Class II section
	04 Rectal canal (canal)	Class II section
	05 ureteral stents	Class II section
	06Drainage catheter	II
	07 Dilate the catheter	II
	08 Contrast catheter	II
	09 Manometric catheter	II
06 In vitro instruments for non-intravascular catheters	01 Extracranial drainage collection device	II
	02 Chest drainage device	II
	05 negative pressure drainage sponge	Class II section
	06 Negative pressure drainage sealing membrane	II
12. Stoma, scar care products	02Scar repair materials	II
14 Protective equipment for medical personnel	01 Protective mask	II
14 Protective equipment for medical personnel	02Protective clothing	II

12.
16 ophthalmic instruments

Tier <> product category	Secondary product categories	Manage categories
03Optometric equipment and appliances	03Vision therapy equipment	II
04Ophthalmic measurement and diagnosis equipment and utensils	01Ophthalmic laser diagnostic equipment	Class II section
05Ophthalmic treatment and surgical equipment, auxiliary devices	04Ophthalmic cryotherapy equipment	II
	06Ophthalmic treatment and surgical aids	Class II section
07Ophthalmic implants and assistive devices	14 prosthetic eye tablets	Class II section
	15 intraocular lens, artificial vitreous Implantable devices	Class II section
	16 Bag tension ring implantation device	Class II section

13.
18 Obstetrics and gynecology, assisted reproduction and contraceptives

Tier <> product category	Secondary product categories	Manage categories
01 Obstetrics and gynecology surgical instruments	05Dilators and retractors for obstetrics and gynecology	Class II section
01 Obstetrics and gynecology surgical instruments	10 Hysterosalpingography, fallopian tubes Liquid ventilation instruments	Class II section
04 Obstetrics and gynecology treatment equipment	02Gynecological prosthetic devices	Class II section
07 Assisted reproductive devices	01 Assisted reproductive catheters	II
	02 Assisted reproduction puncture for egg retrieval/semen needle	II
	03 Assisted reproduction miniature tools	II

14.
19 Medical rehabilitation equipment

Tier <> product category	Secondary product categories	Manage categories
01 Rehabilitation equipment for cognitive speech and hearing disorders	07 Hearing aids	II

15.
22 Clinical testing instruments

Tier <> product category	Secondary product categories	Manage categories
01 Hematological analysis equipment	02 Blood cell analysis instrument	II
11 Sampling equipment and appliances	04 Venous blood sample blood collection blood vessels	II

12.
16 ophthalmic instruments 13.
18 Obstetrics and gynecology, assisted reproduction and contraceptives 14.
19 Medical rehabilitation equipment 15.
22 Clinical testing instruments

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