Official article, upgrading the supervision of Class II and III medical devices!

2023-07-06

In less than a year, the third batch of medical device “ID card” will be landed in the country. After the medical devices leave the factory, they will be traceable in circulation and use.
With the “dual code combination” of medical consumables, catalog access, payment management, and volume bidding will also be more intelligent and transparent.

01 Tianjin announced 16 UDI demonstration units

Recently, the Tianjin MPA issued the Notice of the Tianjin MPA on Doing A Good Job in the Demonstration and Promotion of the UDI of Medical Devices (hereinafter referred to as the Notice).

“Notice” points out that from June 1, 2024, the third batch of medical device varieties of medical devices unique identification (hereinafter referred to as “UDI”) will be fully implemented in the country. In order to further do a good job in UDI global application and demonstration promotion, Tianjin MPA organized the selection of UDI demonstration units in the city.

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

02 103 varieties of medical devices with codes for use and settlement

The full implementation of UDI for Class III medical devices, Class II medical devices will also have “ID cards”.

In February this year, the NMPA, the National Health Commission, and the National Healthcare Security Bureau issued the “Announcement on the Implementation of the Third Batch of Unique Identification of Medical Devices” (hereinafter referred to as the “Announcement”), according to the degree of risk and regulatory needs, which determines some disposable products with greater clinical demand, selected products with centralized procurement, medical beauty related products and other second class medical devices will be the implementation varieties as third batch of medical devices unique identification.

These include ultrasonic surgical equipment accessories, medical laser fiber, high-frequency/radiofrequency electrodes and catheters, perfusion pumps for radiofrequency ablation equipment, active equipment for endoscopic surgery, electric staplers, vascular suture devices, non-absorbable sutures, bone cement instruments, peritoneal dialysis equipment, pacemaker system analysis equipment, angiography catheters, ophthalmic cryotherapy equipment, hearing AIDS, blood cell analysis Instruments and other 103 varieties of medical equipment. According to the regulations, the above medical devices produced from June 1, 2024, shall have the UDI of medical devices.

UDI’s landing work involves production, operation of enterprises and medical institutions.

The Announcement clearly states that medical device registrants should effectively implement the entity responsibility, encourage the establishment of a sound traceability system based on unique identifiers, and do a good job in product recall, tracking and traceability.

Medical device business enterprises should actively apply UDI in business activities, do a good job of entering and leaving the warehouse with codes, and achieve traceability of products in the circulation process.

Medical institutions should actively apply UDI in clinical practice such as clinical use, payment charging and settlement reimbursement, and do a good job of recording the whole process with codes to achieve product traceability in clinical links.

03 Dual code integration, comprehensive upgrade of consumables management

The landing of the UDI code and the national healthcare security code are two major events affecting the medical device industry.

At present, both are in the stage of rapid promotion, and the docking of “double code” will also make the multi-link management of consumables optimized.

According to the aforementioned Announcement, the provincial healthcare security department should strengthen the associated use of healthcare security, medical consumables classification and code with the UDI of medical devices, and promote the transparency and intelligence of catalog access, payment management, and volume bidding.

At the local level, the MPA, health committee and healthcare security department should forme a joint force to promote the linkage .

For example, Henan Province has made it clear that it is necessary to promote the application of the UDI of medical devices in the whole field, strengthen the convergence and application of device supervision, medical management, and healthcare security management, and gradually realize data sharing. In the medical insurance link, strengthen the use of healthcare security ,medical consumables code and medical device UDI, and explore the application mode of medical device UDI in the centralized purchase of medical consumables and healthcare security settlement.

After the “dual code” integration, medical consumables will achieve closed-loop management of the whole process, and under intelligent supervision, management loopholes will be filled.

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

Author：Dongtai

Source：Saibolan Device

Translated & edited ：Bradyknows

Official article, upgrading the supervision of Class II and III medical devices!

01

Tianjin announced 16 UDI demonstration units

Recently, the Tianjin MPA issued the Notice of the Tianjin MPA on Doing A Good Job in the Demonstration and Promotion of the UDI of Medical Devices (hereinafter referred to as the Notice).

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

02

103 varieties of medical devices with codes for use and settlement The full implementation of UDI for Class III medical devices, Class II medical devices will also have “ID cards”.

UDI’s landing work involves production, operation of enterprises and medical institutions.

The Announcement clearly states that medical device registrants should effectively implement the entity responsibility, encourage the establishment of a sound traceability system based on unique identifiers, and do a good job in product recall, tracking and traceability.

Medical device business enterprises should actively apply UDI in business activities, do a good job of entering and leaving the warehouse with codes, and achieve traceability of products in the circulation process.

Medical institutions should actively apply UDI in clinical practice such as clinical use, payment charging and settlement reimbursement, and do a good job of recording the whole process with codes to achieve product traceability in clinical links.

03

Dual code integration, comprehensive upgrade of consumables management

The landing of the UDI code and the national healthcare security code are two major events affecting the medical device industry.

At present, both are in the stage of rapid promotion, and the docking of “double code” will also make the multi-link management of consumables optimized.

At the local level, the MPA, health committee and healthcare security department should forme a joint force to promote the linkage .

After the “dual code” integration, medical consumables will achieve closed-loop management of the whole process, and under intelligent supervision, management loopholes will be filled.

103 varieties of medical devices with codes for use and settlement

The full implementation of UDI for Class III medical devices, Class II medical devices will also have “ID cards”.