This article discusses NMPA Certification the decision to implement unique identification of medical devices for some Class II medical devices in order to continue implementing the Regulations on the Supervision and Administration of Medical Devices, the Notice of the General Office of the State Council on Printing and Distributing the Reform Plan for the Governance of High-Value Medical Consumables, and the relevant key tasks of the State Council in furthering the re-enactment of the Reform Plan for the Governance of High-Value Medical Consumables by NMPA Certification
The following information is announced as relevant:
Broad range
Class II medical devices, such as disposables with high clinical demand, specific items with centralized procurement, and medical cosmetology-related items, are selected for unique identification based on risk and regulatory requirements.
Schedule
Registrants must carry out work in accordance with time limit requirements.
- Individual identifying and coding
Medical devices must have unique identification and a label that specifies the date of manufacture.
- Submission of a unique identifier registration system
After June 1, 2024, a person must submit the product identification of the product’s smallest sales unit in the registration management system, as an existing registration is required.
- Distinguish database entries
The registrant must upload product identification and related data of the smallest sales unit and higher-level packaging to the unique identification database of the medical device in accordance with relevant standards or specifications. This is necessary to supplement and improve the medical insurance medical consumables classification and code fields in the unique identity database and to ensure that the data is true, accurate, complete, and traceable. The data must also be changed when the product ID is updated before the product is placed on the market.
Relevant conditions
Medical device registrants should implement their responsibilities to promote the establishment and improvement of traceability systems based on unique identification, product recall, tracking, and tracing, and to ensure compliance with the Classification Catalog of Medical Devices. Code-issuing institutions should formulate standards and guidelines for the compilation of unique identifiers, guide medical device registrants in carrying out the creation and coding of personal identifiers, and verify the readability of unique identifiers prepared in accordance with their standards in circulation and use. Provincial-level drug regulatory departments should strengthen training and guidance in their jurisdictions to carry out product coding, data uploads, and maintenance as required, strengthen coordination with the health and medical insurance departments in their jurisdiction, and promote the linkage of the three doctors. Additionally, provincial-level health departments should guide medical institutions within their jurisdictions by actively applying unique identifiers and strengthening the standardized management of medical devices in clinical applications.The third batch of product catalogs implementing unique identification for medical equipment is now available. Annexure
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Source : nmpa.gov.cn
