NMPA: Accelerating the implementation of the unique identification system

On January 16, the 2023 National Medical Device Supervision and Management Work Conference was held in Beijing, and the meeting called for accelerating the implementation of the unique identification system.

141kinds of medical devices will implement UDI

On November 30, 2022, the NMPA issued a notice on the third batch of unique identification of medical devices (draft for comment).

The RFP mentions:

According to the degree of risk and regulatory needs, some disposable products with large clinical demand, varieties included in the scope of medical insurance centralized purchase, and the second class of medical devices related to medical beauty products are determined as the UDI implementation varieties of the third batch of medical devices.

For the medical devices listed in the third batch of implementation product list, the registrant shall orderly carry out the following work in accordance with the time limit requirements:

Medical devices manufactured after June 1, 2024 shall have the unique identification of medical devices.

For applications for registration from June 1, 2024, the registration applicant shall submit the product identification of its minimum 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 minimum sales unit in the registration management system when the product is registered continuously or changed.

For medical devices manufactured after June 1, 2024, before they are put on the market, the registrant shall, in accordance with relevant standards or specifications, upload the product identification of the minimum sales unit and higher packaging and relevant data into the unique identification database of medical devices to ensure that the data is true, accurate, complete and traceable.

Failure to implement as required, fine!

Article 79 of the Measures for the Supervision and Administration of Medical Device Production:

Under any of the following circumstances, the drug regulatory department shall, according to its functions and duties, order correction within a time limit; Those who refuse to make corrections shall be fined not less than 10,000 yuan but not more than 50,000 yuan; If the circumstances are serious, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed:

（1）Failing to change the registered items of the medical device production license in accordance with Article 16 of these Measures;

(2) failing to organize code assignment, data uploading, maintenance and update in accordance with the relevant requirements of the State for the unique identification of medical devices.

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Source：CMDRA

Translated & edited by Bradyknows