From June 1st, the Class III Medical Devices to be Fully Regulated.

The work of unique identification of medical devices has entered the last mile.

Previously, it was clearly pointed out in the Announcement on the Second Batch of Implementation of the Unique Identification of Medical Devices jointly issued by the NMPA, the State Health Commission and the State Medical Insurance Administration that from June 1, based on the 9 categories and 69 varieties specified in the Announcement of the NMPA, the National Health Commission, and the National Medical Insurance Administration on Further Promoting the Pilot Program and Doing a Good Job in Implementing the First Batch of Unique Identification of Medical Devices” (No. 106 in2020), the remaining class III medical devices (including in vitro diagnostic reagents) shall be included in the scope of the second batch of unique identification.

According to the announcement, from June 1, 2022, the medical devices produced shall have the unique identification of medical devices. Before marketing, the registrant shall upload the product identification and relevant data of the smallest sales unit and higher-level packaging to the unique identification database of medical devices in accordance with the requirements of relevant standards or specifications, so as to ensure the authenticity, accuracy, integrity and traceability of the data.

According to the Announcement, from June 1, 2022, the medical devices produced shall have the unique identification of medical devices. Before marketing, the registrant shall upload the product identification and relevant data of the smallest sales unit and higher-level packaging to the unique identification database of medical devices in accordance with the requirements of relevant standards or specifications, so as to ensure the authenticity, accuracy, integrity and traceability of the data.

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

The Announcement specifically points out that medical device registrants shall earnestly implement the main responsibility of enterprises, encourage the establishment and improvement of traceability system based on unique identification, and do a good job in product recall, tracking and tracing.

Medical institutions shall actively apply unique identification in clinical practice, such as clinical use, payment, settlement and reimbursement, and make code records in the whole process, so as to realize the traceability of products in clinical links.

The Announcement  also stresses that the provincial level health department shall strengthen the standardized management of medical devices in clinical application. Provincial level medical insurance departments shall also strengthen the association in medical security medical consumables classification , code and  the unique identification of medical devices, and the directory access, payment management and volume bidding shall be more transparent.

Failure to comply with the requirements shall result in a fine of 100000 yuan

On May 1, the new version of the Measures for the Supervision and Administration of Medical Device Production has been implemented, which clearly stipulates the unique identification of medical devices.

According to article 36, medical device registrants, recorders and entrusted manufacturing enterprises shall carry out code assignment, data upload, maintenance and update in accordance with the relevant requirements of the state for the implementation of the unique identification of medical devices.

According to article 79, those who fail to organize code assignment, data upload, maintenance and update in accordance with the relevant requirements of the state for the implementation of the unique identification of medical devices shall be ordered by the drug regulatory department to make corrections within a time limit according to its duties; Those who refuse to make corrections shall be fined not less than 10000 yuan but not more than 50000 yuan; If the circumstances are serious, a fine of not less than 50000 yuan but not more than 100000 yuan shall be imposed.

In addition, article 30 of the new version of the measures for the supervision and administration of medical device operation also stipulates that medical device operation enterprises shall implement the unique identification system of medical devices in accordance with the relevant provisions of the state, and shall establish and implement a product traceability system to ensure product traceability.

The unique identification of medical devices (hereinafter referred to as UDI) refers to the code composed of numbers, letters or symbols attached to the products or packages of medical devices, which is used for the unique identification of medical devices and is equivalent to the electronic ID card of medical devices.

Previously, there was a common phenomenon of no code or multiple codes for one object in the circulation and use of medical devices, which seriously affected the accurate identification of medical devices in the production, circulation and use of medical devices, and it was difficult to achieve effective supervision and management.

From January 1, 2021, the first batch of 69 medical device varieties in 9 categories has been uniquely identified.

According to observation, the local drug administration departments have recently issued documents to promote the unique identification of medical devices, and guide the application of UDI in various fields such as device supervision, medical management, and medical insurance management.

In April this year, Henan Province issues the Implementation Plan for Promoting the Work of Unique Identification of Medical Devices, which clearly states that it is necessary to promote the application of unique identification of medical devices in all fields, strengthen the connection and application of device supervision, medical management, medical insurance management and other fields, and gradually realize the data Sharing, to promote the implementation of the unique identification of medical devices in the fields of medical care, medical insurance, and medicine, and to coordinate the promotion of “three medical linkages”.

In the medical insurance link, strengthen the use of the medical insurance medical consumables code and the unique identification of medical devices, and explore the application mode of the unique identification of medical devices in the centralized procurement of medical consumables and medical insurance settlement.

In March this year, Shandong Province issues the Application Guidelines for the Implementation of the Unique Identification of Medical Devices (UDI), which suggests that medical institutions should compare the internal medical device product data with the UDI basic data, so that the UDI information follows the dictionary database information throughout the procurement of medical devices, Acceptance, storage, delivery, clinical use, billing, settlement and other links.

It is noteworthy that in addition to class III medical devices, class II medical devices in Hainan, Fujian, Sichuan, Beijing, Tianjin and other provinces have successively carried out the unique identification of medical devices.

Source: Saibolan Instrument

Edited and translated by ：Bradyknows

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