Article 1 To strengthen the supervisory management of medical
devices in the process of development, production, operation and
use, improve the efficiency of supervisory management, establish a
unique identification system for medical devices and innovate the
supervisory management mode of medical devices, the Rules are
formulated in accordance with relevant provisions of the
Regulations on Supervisory Management of Medical Devices.
Article 2 Medical devices sold or used within the territory of
the People’s Republic of China shall conform to the requirements of
Article 3 The unique identification system of medical device
referred to in these rules consists of unified device identification,
unique identification data carrier and unique identification database,
jointly constructing the uniform identification system of medical
The unique identifier of a medical device refers to a code
consisting of numbers, letters or symbols attached to a medical
device product or package for unique identification of the medical
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Medical device unique identification data carrier refers to the
data medium that stores or transmits the unique identifier of the
The medical device unique identification database refers to a
database that stores product identification and related information
uniquely identified by the medical device.
Article 4 The Rules refer to internationally-recognized
standards. The Rules shall be guided by government principles,
implemented by enterprises, and be implemented step-by-step.
China National Medical Product Administration (NMPA) is
responsible for establishing the unique identification system for
medical devices, formulating and issuing the implementation plan of
the unique identification system for medical devices.
Article 5 The unique identification of medical devices in these
rules refers to the alphanumeric code presented on the products or
packages of medical devices, which is used for the unique
identification of medical devices.
Article 6 Unique identification of medical devices shall include
product identification and production identification. Product
identification is the unique code to identify the medical device
registrant or filer as well as medical device model, specification and
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packaging; Production identification is the code to identify the data
related to the production process of medical devices. According to
the supervisory management and practical application requirements,
the serial number, production batch number, production date and
expiration date of medical devices can be included.