Bryan Gilburg - China

The new announcement provides the UDI implementation requirements for 103 types of Class II medical devices. These product types will need to have UDI labeling by June 1, 2024.”

Bryan Gilburg

Managing Director

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NMPA Continues UDI Implementation in China with Third Batch Release

Published on: March 1st, 2023

Third Batch of UDI Implementation in China Includes Some Class II Devices

On February 17, 2023, the State Food and Drug Administration, the National Health Commission, and the National Medical Insurance Administration issued an announcement regarding the implementation of the third batch of unique device identification (UDI) of medical devices in China.

This announcement is aimed at further implementing 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 of the State Council to deepen the reform of the medical and health system.

The following 103 types of class II medical devices belong to the third batch and will need to have UDI labeling by June 1, 2024.

Please contact Asia Actual today to learn more about your product’s UDI requirements or if you’re interested in entering the Chinese market.

Third Batch UDI Implementation Update: 103 Class II Medical Devices

According to the announcement, some class II medical devices, such as single-use products with large clinical demand, selected products in centralized procurement, and medical cosmetology-related products, have been determined as the third batch of medical device UDI implementation varieties. In total, there are 103 types of class II medical devices (see the full list below).

The schedule for the implementation of the third batch of UDI of medical devices is as follows:

  1. Assignment of a unique identifier: Medical devices produced from June 1, 2024, shall have a UDI for medical devices, and the third batch of products with UDI that have been produced before may not have a UDI.
  2. Submit to the unique identifier registration system: For those who apply for registration from June 1, 2024, the registration applicant shall submit the product identification of the smallest sales unit of the product in the registration management system.
  3. UDI database submission: For medical devices produced from June 1, 2024: Before they go on the market, the registrant shall upload the product identification and related data of the minimum sales unit, as well as the higher-level packaging to the unique medical device identification database.

The announcement also includes relevant requirements for medical device registrants, operating companies, and medical institutions, such as establishing a sound traceability system based on the UDI and actively applying unique identifiers in their business activities and clinical practice.

This announcement by the State Food and Drug Administration, the National Health Commission, and the National Medical Insurance Administration regarding the implementation of the third batch of UDI of medical devices is a significant step towards strengthening the supervision and management of medical devices and promoting the development of the medical and health system.

Class II Product Types Included in the Third Batch of UDI Implementation

01 Active Surgical Instruments

First-level Product Category Secondary Product Category Management Category
01 Ultrasonic surgery equipment and accessories 03 Ultrasonic surgery equipment accessories II part
02 Laser surgery equipment and accessories 02 Medical Laser Fiber II
03 High frequency/radio frequency surgical equipment and accessories 01 High frequency surgical equipment Class II part
03 Argon protection gas condensation equipment II
04 Electrodes and catheters for high frequency/radio frequency Class II part
05 Irrigation pump for radiofrequency ablation equipment II
09 Endoscopic surgery with active

equipment

01 Active equipment for endoscopic surgery II part
10 Other Surgical Equipment 03 electric stapler II part
04 Surgical power system II

02 Passive Surgical Instruments

First-level Product Category Secondary Product Category Management Category
13 Surgical instruments – kiss (suture) instruments and materials 01 stapler (with nails) Class II part
02 stapler (without nails) Class II part
03 Kiss (suture) instruments for endoscopy

(without nails)

II
04 Vascular suturing device Class II part
07 Non-absorbable sutures II

03 Nerve and Cardiovascular Surgical Devices

First-level Product Category Secondary Product Category Management Category
13 Neuro and Cardiovascular Surgical Devices – Cardiovascular Interventional Devices 04 Catheter Sterile Connector II
12 puncture needles II
14 introducer sheath II
15 dilators II
17 Balloon inflation device for balloon dilatation catheter II
18 connection valve II
25 extension tube II

04 Orthopedic Surgical Instruments

First-level product category Secondary Product Category management category
07 Orthopedic Cone 01 Bone awl for interventional surgery II
12 Orthopedic Active Devices 01 Orthopedic power surgery equipment II
02 Supporting tools Class II part
13 External fixation and traction devices 02 External fixation bracket Class II part
14 Basic general aids 01 Minimally Invasive Bone Guide II
02 Bone cement instrument Class II part
03 Bone grafting device Class II part
16 Joint Surgical Auxiliary Instruments 01 bone cement setting mold Class II part
17 Auxiliary instruments for spinal surgery 03 Injection propulsion device Class II part
04 Vertebroplasty guidance system II
05 Annulus suture instrument II
06 Vertebral Posterior Edge Processor II
13 Spinal Surgery Channel Instruments II
15 supporting tools Class II part
18 Other Orthopedic Surgical Instruments 02 Skull Orthopedic Devices II

06 Medical Imaging Devices

First-level Product Category Secondary Product Category Management Category
01 Diagnostic X-ray machine 02 Urinary X-ray machine II
04 Dental X-ray machine Class II part
16 Endoscopic Auxiliary Products 06 Biopsy bag for endoscope II
07 Endoscopic bite, sleeve Class II part

07 Medical Diagnosis and Monitoring Equipment

First-level Product Category Secondary Product Category Management Category
10 Accessories and consumables 03 body surface electrodes II
04 Pulse oximeter sensor II
05 Conductive Paste II

08 Respiratory, Anesthesia and First Aid Equipment

First-level Product Category Secondary Product Category Management Category
05 Auxiliary devices for breathing, anesthesia, and first aid equipment 07 Atomization equipment / atomization device II
06 Breathing, anesthesia tubes, masks 03 endotracheal intubation / endotracheal tube II
04Esophageal and tracheal intubation II
05 laryngeal mask II
06 Oropharyngeal/nasopharyngeal airway II
07 bronchial occluder II
08 nasal oxygen tube Class II part
09 suction catheter for airway

(suction tube)

II

09 Light Therapy Equipment

First-level Product Category Secondary Product Category Management Category
03 Light therapy equipment 01 Laser therapy equipment Class II part
02 Photodynamic laser therapy equipment Class II part
04 Intense pulsed light therapy equipment II
05 Red light therapy equipment II
06 Blue light therapy equipment II

10 Blood Transfusion, Dialysis and Extracorporeal Circulation Equipment

First-level Product Category Secondary Product Category Management Category
03 Blood purification and peritoneal dialysis equipment 06 Peritoneal dialysis equipment II
04 Blood purification and peritoneal dialysis equipment 04 Peritoneal dialysis equipment Class II part

12 Active Implantable Devices

First-level Product Category Secondary Product Category Management Category
01 Heart rhythm management equipment 10 Pacing system analysis equipment II
11 Heart rhythm management program-controlled equipment II
12 connector sleeve II
02 Neuromodulation equipment 07 Test stimulator II
08 Test extension lead II
09 Neural regulation program-controlled equipment II
03 Auxiliary hearing equipment 02 External sound processor II
03 Auxiliary auditory control equipment II
04 other 01 Implantable cardiac contractility

Adjustment equipment

Class II part

14 Infusion, Nursing and Protective Equipment (PPE)

First-level Product Category Secondary Product Category Management Category
01 Injection and puncture equipment 01 Syringe pump Class II part
04 pen syringe II
07 Syringe auxiliary push device Class II part
02 Intravascular infusion device 01 Infusion pump Class II part
12 Devices for transferring and dispensing medicinal liquid II
05 Non-intravascular guide (insertion) tube 02 Nasoenteral nutrition catheter II
03 catheter Class II part
04 rectal tube (anal tube) Class II part
05 Ureteral stent Class II part
06 drainage catheter II
07 Dilation Catheter II
08 contrast catheter II
09 Manometry Catheter II
06 Extracorporeal devices used in conjunction with non-intravascular catheters 01 Extracranial drainage collection device II
02 Chest drainage device II
05 negative pressure drainage sponge Class II part
06 Negative pressure drainage sealing film II
12 Ostomy, scar care products 02 Scar Repair Materials II
14 Protective equipment for medical staff 01 protective mask II
02 protective clothing II

16 Ophthalmic Devices

First-level Product Category Secondary Product Category Management Category
03 Optical equipment and appliances 03 Vision therapy equipment II
04 Ophthalmic measurement and diagnosis equipment

and utensils

01 Ophthalmic laser diagnostic equipment Class II part
05 Ophthalmic treatment and surgery equipment, assistive devices 04 Ophthalmic cryotherapy equipment II
06 Ophthalmic Therapeutic and Surgical Aids Class II part
07 Ophthalmic implants and auxiliary devices 14 prosthetic eye tablets Class II part
15 Intraocular lens, artificial vitreous body

implanted device

Class II part
16 capsular tension ring implantation device Class II part

18 Obstetrics and Gynecology, Assisted Reproduction and Contraceptive Devices

First-level Product Category Secondary Product Category Management Category
01 Obstetrics and Gynecology Surgical Instruments 05 Dilators and retractors for obstetrics and gynecology Class II part
10 Hysterosalpingography, fallopian tubes

Fluid device

Class II part
04 Obstetrics and gynecology treatment equipment 02 Gynecological prosthetic devices Class II part
07 Assisted reproductive devices 01 Assisted reproductive catheter II
02Assisted reproductive puncture egg retrieval/sperm needle II
03 Assisted reproductive microtools II

19 Medical Rehabilitation Equipment

First-level Product Category Secondary Product Category Management Category
01 Rehabilitation equipment for cognitive speech and audio-visual impairment 07 hearing aids II

22 Clinical Laboratory Equipment

First-level Product Category Secondary Product Category Management Category
01 Hematology analysis equipment 02 Blood cell analysis instrument II
11 Sampling equipment and utensils 04Venous blood sampling tube II

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