Starting from June 1st, 103 types of instruments have started real name management
Last February, the National Medical Products Administration, the National Health Commission, and the National Healthcare Security Administration jointly issued a notice on the implementation of the third batch of unique labeling for medical devices.
The 103 medical devices that implement real name registration include ultrasound surgical equipment, laser surgical equipment and accessories, high-frequency/radiofrequency surgical equipment and accessories, active equipment for endoscopic surgery, cardiovascular intervention equipment, orthopedic surgical equipment, diagnostic X-ray machines, phototherapy equipment, pacing system analysis equipment, injection pumps, clinical testing equipment, etc.
The Announcement requires:
Unique identifier assignment: Products in the catalogue shall have a medical device UDI for medical devices manufactured from 1 June 2024 onward, while products previously manufactured in the third batch of the implementation of the unique identifier may not have a unique identifier. The date of manufacture is based on the device label.
Submission of Unique Identifier Registration System: If the application for registration is made from 1 June 2024, the applicant for registration shall submit the product identifier of the smallest unit of sale of the product in the registration management system.
UDI database submission: for medical devices manufactured from 1 June 2024 onwards, prior to marketing, registrants should upload data relating to the product identification and smallest unit of sale of a unique medical device, as well as a higher level package identification database.
On 1 January 2021, the first batch of 69 varieties of 9 categories began to implement the unique identification of medical devices. 1 June 2022, other Class III medical devices (including in vitro diagnostic reagents) as the second batch of implementation of varieties of the full implementation of the unique identification of medical devices. This time, in accordance with the degree of risk and regulatory needs, to determine part of the clinical demand for larger single-use products, centralised volume purchasing selected products, medical beauty-related products and other parts of the second class of medical devices as the third batch of medical devices unique marking implementation varieties.
For production enterprises: upgrading the entire process
Production enterprises need to comprehensively upgrade their internal facilities, establish and improve product traceability and recall mechanisms, and train upstream and downstream suppliers and distributors. Specific measures include:
- Upgrading of internal facilities: upgrading of production equipment to ensure that it is capable of generating and printing unique identification.
2. Product traceability and recall mechanism: establish a complete product traceability system to ensure that every product can be traced back to the source of production and can be quickly recalled in case of problems.
3. Supply chain training: Provide comprehensive training to suppliers and distributors to ensure that the requirements related to unique marking are understood and implemented throughout the supply chain.
4.Inbound and outbound with code: Scan and record the unique identification when the product is inbound and outbound to ensure the traceability of the product in the circulation process.
5、Inventory management: Use the unique identification for accurate inventory management, reduce waste and improve efficiency.
For medical institutions: clinical use Payment settlement
Medical institutions need to apply unique identification in clinical use, payment of fees, settlement and reimbursement processes to ensure full traceability. Specific measures include:
1. Clinical usage record: Record the unique identification of the product during clinical use to ensure that every step is traceable.
2. Payment and settlement: Use a unique identifier in the payment and settlement process to ensure clear accounts and reduce disputes.
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：Device Market
Translated & edited： Bradyknow
