Each Marketing Authorization certificate issued by the NMPA ( Natioanl Medical Products Administration) for a medical device contains a unique certificate number. The number is composed of Chinese characters and a series of numbers. These certificate numbers follow a structured coding rule and convey significant information about the registered device, which makes the decoding process straightforward for those familiar with the system.
1. Why’s it relevant
At a glance, an experienced regulatory affairs professional can at least determine:
1) the initial approval year of the device, and the potential year for filing an extension
2) the approval location
3) whether the device is domestic or imported product, and
4) the general category of the device
2. How to systematically analyze the certificate number
We have four certificate numbers as examples below. They can be broken down into six key components.
① Represents the abbreviation of the registration approval authority’s location, where:
· The Character “国”, literally means “State” indicates approval by the National Medical Products Administration (NMPA)at the state level (national NMPA). Currently, Class III domestic medical devices and Class II/III imported medical devices are approved by the national NMPA. The approval decision will be made at a state level with the option to delegate the approval process to the NMPA affiliated organisations, such as the Yangtze River Delta Center and the Guangdong-Hong Kong-Macao Greater Bay Area Center.
· The Character “琼”, literally is the abbreviation of Hainan Province, indicates approval by the provincial, autonomous region, or municipal Medical Products Administration (provincial NMPA). In this case, Each province has its own character. Currently, provincial authorities in China are only authorized to approve Class II domestic medical devices.
② Represents the origin of the medical device, where:
· “准” indicates a domestically produced medical device by a local Chinese enterprise.
· “进” indicates an imported medical device.
· “许” indicates a medical device from Hong Kong, Macau, or Taiwan.
Combining point ① and ② , an imported medical device will only have a registration number as 国 械 注 进 *** :
③ Represents the year of initial registration. Currently, the marketing authorisation from NMPA is valid for five years. (Article 22, Regulations on the Supervision and Administration of Medical Devices” (State Council Order No. 739).)
④ Represents the medical device category management number, where:
· “2” represents a Class II medical device.
· “3” represents a Class III medical device.
· part ④ will never be I, because Class I medical device does not need registration in China
⑤ Represents the last two digits of the device classification code for the medical device. The device classification refers to the product type classification catalogue. Currently there are 23 codes for the general type of medical device（Center for Medical Device Evaluation):
01. Active Surgical Instruments
02. Non-active Surgical Instruments
03. Neurological and Cardiovascular Surgical Instruments
04. Orthopedic Surgical Instruments
05. Radiotherapy Instruments
06. Medical Imaging Instruments
07. Medical Diagnostic and Monitoring Instruments
08. Respiratory, Anesthesia, and Emergency Instruments
09. Physical Therapy Instruments
10. Blood Transfusion, Dialysis, and Extracorporeal Circulation Instruments
11. Medical Device Disinfection and Sterilization Instruments
12. Active Implantable Devices
13. Non-active Implantable Devices
14. Injection, Nursing, and Protective Instruments
15. Patient Support Instruments
16. Ophthalmic Instruments
17. Dental Instruments
18. Obstetrics, Assisted Reproduction, and Contraceptive Instruments
19. Medical Rehabilitation Instruments
20. Traditional Chinese Medicine Instruments
21. Medical Software
22. Clinical Laboratory Instruments
23. General Medical Devices
⑥ Represents the initial registration serial number, consisting of four digits.
With this knowledge, the NMPA registration number will no longer just be dry digits.