NMPA Issued the Announcement on Effective Implementation of Unique Identification for the First Batch of Medical Devices
The Rules for Unique Identification System for Medical Devices (hereinafter referred to as the Rules), released in August 2019, has ushered in the stepwise implementation of Unique Identification system for medical devices. On October 14, 2019, NMPA issued the Announcement on Effective Implementation of Unique Identification for the First Batch of Medical Devices (hereinafter referred to as the Announcement), which clearly defines the scope, schedule and work requirements of unique identification for the first batch of medical devices. According to the Announcement, from October 1, 2020, the medical devices listed in the first batch for implementation should have the unique identification.
As per the degree of risk and regulatory needs, the Announcement identifies some high-risk Class III medical devices such as active/passive implants into the first batch. Nine categories and 64 varieties, say cardiac pacemakers, hip prostheses, and plastic injection fillers, etc., were also enlisted in the first product catalogue for the first batch. As per the Announcement, for medical devices listed in the first batch, the registrant shall follow the Rules, timely, orderly and effectively perform the coding of Unique Identification, and complete the submission of the registration system and database for unique identification. As per the Announcement, unique identification is optional prior to October 1, 2020, but mandatory for all medical devices produced thenceforward (judged by the date of manufacture on the tags of medical devices).
The Announcement requires that, as from October 1, 2020, when applying for initial registration, registration renewal or alterations, the registered applicant/registrant shall submit the product identification of the smallest sales unit in the registration management system. The product identification does not constitute a registration review item, therefore its individual change of identification does not belong to the category of registration alterations.
The Announcement further states that, before the sale of medical devices produced since October 1, 2020, the registrant shall, in accordance with the relevant standards or specifications, upload the product identification and related data of the minimum sales unit and higher-level packaging to the unique identification database of medical devices; and ensure data alteration and update where any data related changes arise. When the product identification of the minimum sales unit of the medical device changes, the data should be uploaded to the unique identification database per the newly added product identification.
The Announcement also requires that the registrants for the first batch shall strictly follow the requirements to organize the coding, data uploading and maintenance, and shall be responsible for the authenticity, accuracy and completeness of the data. Registrants are encouraged to apply medical device unique identification to establish medical device information-based traceability system, to realize traceability of the whole process of production, circulation and use of the products. Medical device manufacturers and distributors and users are encouraged to actively apply the unique identification of medical devices in their relevant management activities, and explores the establishment of upstream and downstream traceability chain, to promote the convergence of applications. Relevant departments shall actively carry out training and publicity.