UDI of medical device in China marches rapidly
Resource: GS1 | The Global Language of Business
Medical Device which needs UDI in China
Stand: DecDec, 2022
As of June. 2022, Unique Device Identifier (UDI) is obligatory for ALL class III medical devices. UDI is indispensable at submission dossier, on all size of packagings, product itself (disposable and re-sterilised device exempted), at procurements as tender after approval, at incident reporting and medical reimbursement. In Dec. 2022 a draft of 141 class II medical device was publicated which shoold be valis as of June. 2024.
Background
The UDI is composed of two parts: Device Identifier (DI) + Production Identifier (PI). The purpose of a UDI system can be summarized as follows:
a. traceability of medical devices, especially for field safety corrective actions,
b. adequate identification of medical devices through distribution and use,
c. identification of medical devices in adverse events,
d. reduction of medical errors,
e. documenting and longitudinal capture of data on medical devices
After IMDRF introduces UDI in a guidance in 2013, many countries follow to regulate the traceability and vigilance code of medical device. The US acts as a pioneer as usual to let manufacturers register UDI from high risk products. As EU still struggles with European Databank on Medical Devices (EUDAMED) in which UDI as key parameters is included, Chinese authority NMPA has released the final implementing date of all class III medical devices (June, 2022) and part of class II medical devices (June, 2024).
Art of UDI:
- 1-dimensional barcode
- 2-dimensional barcode
- radio-frequency identification (RFID)
UDI issuing entities in China:
Implementing date of medical device of:
- Class III: see below, first series as of 01, 01, 2021 and second series as of 01, 06, 2022
- Class II: 2024, TBD
- Class I: 2026, TBD
Database of UDI in China
Only Chinese agent (or Chinese subsidiary if applied) in behalf of foreign manufacturers can upload UDI at data base of NMPA.
The UDI has a special character as key parameters at procurements and reimbursement in China. While the Chinese agent of foreign manufacturers is not aware to record UDI after e.g. first and second series of class III medical device, the other parties as local distributor might meet problem to fulfil UDI already at procurements and reimbursement process with provincial stakeholders earlier than implementing date of UDI by NMPA.
We recommend you to have a UDI procedure to handle the new requirements of UDI with central NMPA and with local distributor. The role of Chinese agent and Chinese distributor for foreign manufacturers must be defined and coordinated in good time manner.
Action to do in term of UDI in China
We recommend having procedure and records of UDI in your distribution of medical device in China, not only in legal manufacturer, but also at Chinese distributor.
Please take the following factors into account as of implementation date:
- All medical devices in the 3 series of UDI-implementation should have records in all stakeholders in supply chain. So the medical device is traceable.
- An internal database of registered medical device with UDI besides basic registration certification number, Chinese variant or version, product code, classification, intended use
- UDI of smallest sale unit at product label on medical device
- Submit UDI of smallest sale unit at label on medical device at product registration
- Register all UDI-DIs (at product and packaging), Classification and code of medical consumables for medical insurance in Chinese UDI-Database and “consumables classification and code database”
Third series of medical device to mark and register UDI (141 II medical device groups)
Implementing date and scope of UDI
As of 01, 06, 2024, class II medical devices below in third series which will be manufactured after this date must bear UDI.
As of 01, 06, 2024, UDI-DI on label of the smallest sales unit among these medical devices must be provided at initial -, change registration and renewal.
As of 01, 06, 2024, the info of UDI of these medical devices must be registered at central UDI database. It should be consistent with UDI at data base “National Medical Insurance Administration”. Manufacturers have to supplement medical insurance classification and code at UDI data base.
The change of UDI label doesn’t belong to significant change of products to initial change registration at NMPA. You have just to update the UDI-Database and consumables classification and code database in China.
List of medical device in third UDI-series
The following Chinese product codes are listed in draft guidance of third series of medical device UDI.
01 active surgical instruments
01 Ultrasonic surgery equipment and accessories
03 Ultrasonic surgery equipment accessories
02 Laser surgery equipment and accessories
02 Medical Laser Fiber
03 High frequency/radio frequency surgical equipment and accessories
01 High frequency surgical equipment
03 Argon protection gas condensation equipment
04 Electrodes and catheters for high frequency/radio frequency
05 Irrigation pump for radiofrequency ablation equipment
09 Endoscopic surgery with active equipment
01 Active equipment for endoscopic surgery
10 Other Surgical Equipment as Electric Stapler
04 Surgical power system
02 passive surgical instruments
01 Surgical Instruments - Knife
05 Knife for endoscop
03 Surgical instruments - scissors
03 Scissors for endoscopy
04 Surgical instruments - forceps
09 Endoscopic Tissue Forceps
10 Sampling forceps for endoscope
11 Separating forceps for endoscope
12 foreign body forceps for endoscope
13 Instrument forceps for endoscopy
07 Surgical instruments - needles
04 Endoscopic sampling needle
08 Surgical Instruments - Hooks
02 Hook for endoscope
09 Surgical Instruments - Curettes
02 Endoscopic Tissue Curette
10 Surgical instruments - stripper
02 Stripper for endoscope
11 Surgical Instruments - Retractors
04 Retractor for endoscope
05 Balloon dilator for endoscope
12 Surgical instruments- Piercing introducer
05 Introducer for endoscop
13 Surgical instruments - kiss (suture) instruments and materials
01 stapler (with nails)
02 stapler (without nails)
03 Kiss (suture) instruments for endoscopy (without nails)
04 Vascular suturing device
07 Non-absorbable sutures
15 Surgical instruments - other instruments
16 knot pusher for endoscope
17 Cell brushes for endoscopy
18 endoscopic stone extraction instruments
19 endoscopic incision retractor protector
20 endoscopic stone extraction balloon catheter
21 Balloon catheter for endoscopy
22 endoscope feeder
23 Endoscopic ligation device
03 Nerve and Cardiovascular Surgical Devices
10 Neurological and Cardiovascular Surgical Instruments - Retractors
03 dilator
11 Neurological and Cardiovascular Surgical Instruments - Puncture Introducers
01 hole punch
12 Neurological and Cardiovascular Surgical Instruments - Irrigators
01 Washer
02 cleaning rod
13 Neuro and Cardiovascular Surgical Devices - Cardiovascular Interventional Devices
04 Catheter Sterile Connector
12 puncture needles
14 introducer sheath
15 dilators
17 Balloon inflation device for balloon dilatation catheter
18 connection valve
25 extension tube
04 Orthopedic surgical instruments
01 Orthopedic knife
02 Orthopedic endoscopic knife
02 Orthopedic scissors
01 Scissors for Orthopedic Endoscopy
03 Orthopedic forceps
01 Orthopedic Endoscopic Forceps
05 Orthopedic Needles
02 traction needle
06 Orthopedic scraper
01 Orthopedic endoscope curette
07 Orthopedic Cone
01 Bone awl for interventional surgery
12 Orthopedic Active Devices
01 Orthopedic power surgery equipment
02 Supporting tools
13 External fixation and traction devices
02 External fixation bracket
14 basic general aids
01 Minimally Invasive Bone Guide
02 Bone cement instrument
03 Bone grafting device
16 Joint Surgical Auxiliary Instruments
01 bone cement setting mold
02 Arthroscopy supporting tools
17 Auxiliary instruments for spinal surgery
03 Injection propulsion device
04Vertebroplasty guidance system
05 Annulus suture instrument
06 Vertebral Posterior Edge Processor
13 Spinal Surgery Channel Instruments
15 supporting tools
18 Other Orthopedic Surgical Instruments
01 stripper
02 Skull Orthopedic Devices
06 Medical Imaging Devices
01 Diagnostic X-ray machine
02 Urinary X-ray machine
04 Dental X-ray machine
14 medical endoscope
01 Optical endoscope
03Electronic endoscope
16 Endoscopic Auxiliary Products
06 Biopsy bag for endoscope
07 Endoscopic bite, sleeve
07 Medical diagnosis and monitoring equipment
10 Accessories and consumables
03 body surface electrodes
04 Pulse oximeter sensor
05 Conductive Paste
08 Respiratory, anesthesia and first aid equipment
05 Auxiliary devices for breathing, anesthesia, and first aid equipment
06 Laryngoscope for endotracheal intubation
07 Atomization equipment / atomization device
06 Breathing, anesthesia tubes, masks
03 endotracheal intubation / endotracheal tube
04 Esophageal and tracheal intubation
05 laryngeal mask
06 Oropharyngeal/nasopharyngeal airway
07 bronchial occluder
08 nasal oxygen tube
09 suction catheter for airway (suction tube)
09 Physiotherapy equipment
03 Light therapy equipment
01 Laser therapy equipment
02 Photodynamic laser therapy equipment
04 Intense pulsed light therapy equipment
05 Red light therapy equipment
06 Blue light therapy equipment
10 Blood transfusion, dialysis and extracorporeal circulation equipment
03 Blood purification and peritoneal dialysis equipment
06 Peritoneal dialysis equipment
04 Blood purification and peritoneal dialysis equipment
04 Peritoneal dialysis equipment
12 Active Implantable Devices
01 Heart rhythm management equipment
10 Pacing system analysis equipment
11 Heart rhythm management program-controlled equipment
12 connector sleeve
02 Neuromodulation equipment
07 Test stimulator
08 Test extension lead
09 Neural regulation program-controlled equipment
03 Auxiliary hearing equipment
02 External sound processor
03 Auxiliary auditory control equipment
04 other
01 Implantable cardiac contractility
Adjustment equipment
14 Infusion, nursing and protective equipment
01 Injection and puncture equipment
01 Syringe pump
04 pen syringe
07 Syringe auxiliary push device
08 piercing instrument
09 biopsy needle
02 Intravascular infusion device
01 Infusion pump
12 Devices for transferring and dispensing medicinal liquid
05 Non-intravascular guide (insertion) tube
02 Nasoenteral nutrition catheter
03 catheter
04 rectal tube (anal tube)
05 Ureteral stent
06 drainage catheter
07 Dilation Catheter
08 contrast catheter
09 Manometry Catheter
06 Extracorporeal devices used in conjunction with non-intravascular catheters
01 Extracranial drainage collection device
02 Chest drainage device
05 negative pressure drainage sponge
06 Negative pressure drainage sealing film
12 Ostomy , scar care products
02 Scar Repair Materials
14 Protective equipment for medical staff
01 protective mask
02 protective clothing
16 Ophthalmic devices
03 Optical equipment and appliances
03 Vision therapy equipment
04 Ophthalmic measurement and diagnosis equipmentand utensils
01 Ophthalmic laser diagnostic equipment
05 Ophthalmic treatment and surgery equipment, assistive devices
04 Ophthalmic cryotherapy equipment
06 Ophthalmic Therapeutic and Surgical Aids
07 Ophthalmic implants and auxiliary devices
14 prosthetic eye tablets
15 Intraocular lens, artificial vitreous body implanted device
16 capsular tension ring implantation device
18 Obstetrics and gynecology, assisted reproduction and contraceptive devices
01 Obstetrics and Gynecology Surgical Instruments
05 Dilators and retractors for obstetrics and gynecology
10 Hysterosalpingography, fallopian tubes Fluid device
04 Obstetrics and gynecology treatment equipment
02 Gynecological prosthetic devices
07 Assisted reproductive devices
01 Assisted reproductive catheter
02 Assisted reproductive puncture egg retrieval/sperm needle
03 Assisted reproductive microtools
19 Medical rehabilitation equipment
01 Rehabilitation equipment for cognitive speech and audio-visual impairment
07 hearing aids
22 Clinical laboratory equipment
01 Hematology analysis equipment
02 Blood cell analysis instrument
11 Sampling equipment and utensils
04 Venous blood sampling tube
Second series of medical device to mark and register UDI
In the same year 2021 after publishing first series of class III medical device with UDI requirements, NMPA promulgates the second series of all rest class III medical devices which must be implemented with UDI requirements in Chinese market.
Implementing date of UDI for rest class III medical devices:
As of 01, 06, 2022, all class III medical device in second series which will be manufactured after this date must bear UDI.
As of 01, 06, 2022, UDI-DI on label of the smallest sales unit among these class III medical devices must be provided at initial -, change registration and renewal. As of 01, 06, 2022, the info of UDI of these class III medical devices must be registered at central UDI data base. It should be consistent with UDI at data base “National Medical Insurance Administration”.
First series of medical device to mark and register UDI (including 69 product codes)
Medical device with Product code below is in force to implement UDI as of 01, 01, 2021, it covers only 9 of 22 main product main categories in China:
*The prerequiste to match medical device which needs UDI is knowing 6 digits product code.
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