From 1 June, Class II medical devices will be under full scrutiny!

Just now, the NMPA released the Announcement of the NMPA, National Health Commission, National Healthcare Security Bureau on the Third Batch of Implementation of UDI (No. 22 of 2023)” (hereinafter referred to as the “Announcement”).

The Notice specifies that, in accordance with the degree of risk and regulatory needs, some Class II medical devices, such as single-use products with high clinical demand, products selected through centralized quantity procurement and medical beauty-related products, will be identified as the third batch of medical device unique identification UDI implementation varieties.

The Notice states that for medical devices manufactured from 1 June 2024 onwards, before they are put on sale, the registrant should upload the product identification and related data of the smallest sales unit, higher level packaging to the unique identification database for medical devices in accordance with the relevant standards or specifications to ensure that the data is true, accurate, complete and traceable.

For medical devices whose information has been maintained in the classification and code database of medical insurance consumables of the National Medical Insurance Bureau, the classification and code fields of medical insurance consumables should be supplemented and improved in the unique identification database. At the same time, the information related to the unique identification of medical devices should be improved in the maintenance of the classification and code database of medical insurance consumables, and the consistency with the database data of the unique identification of medical devices should be confirmed.

That is to say, from June 1 this year, 103 categories of medical devices will begin to implement the “real name system”! In accordance with the requirements of the NMPA, those who fail to fill in the product identification (UDI) as required will not sign for the registration and application materials.

This means that from June 1, all Category II medical devices without UDIs will not be registered on the market.

As far as the National Bureau knows, as early as January 1, 2021, the first batch of 69 types of Category III medical devices in 9 categories implemented the unique identification of medical devices.

On June 1, 2022, the second batch of other Class III medical devices (including in vitro diagnostic reagents) implemented the unique identification of medical devices.

This time, with the addition of part of the Class II of medical devices, it indicates that the construction of the national unique identification system of medical devices will be further accelerated, and the dream of traceability of the whole process of production, circulation and use of medical devices will soon be realized.

It can be seen that in the Measures for the Supervision and Administration of the Operation of Medical Devices and the Measures for the Supervision and Administration of the Production of Medical Devices issued by the State last year, the unique identification of medical devices has been clearly stipulated.

In addition, according to Article 36 of the new version of the Measures for Supervision and Administration of Medical Device Production, the registrant, recorder and entrusted manufacturer of medical device shall, in accordance with the relevant requirements of the state for the unique identification of medical device, carry out code assignment, data upload, maintenance and update.

According to Article 79, those who fail to carry out coding, data uploading, maintenance and update in accordance with the relevant state requirements for the unique identification of medical devices shall be ordered by the drug regulatory department to correct within a time limit according to their duties; 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.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source： Medical Device Distributor Alliance

Translated & edited : Bradyknows