Nanjing Elephant-Med instrument Co. , Ltd.
MOBILE：
ADDR：86 Shuanggao Road, Economic Development Zone, Gaochun District, Nanjing City
WEBSITE：http://www.elephant-med.com/
Since the pilot work of the unique identification system for medical devices was launched in July 2019, the unique identification has been demonstrated and applied in all links of the whole chain of medical device production, operation and use, which has effectively boosted the linkage of the whole chain of medical devices from source production to final clinical use. In order to implement 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" (Guo Ban Fa [2019] No. 37) and the key tasks related to deepening the reform of the medical and health system of the State Council, and further expand the application of the unique identification of medical devices in the fields of medical treatment and medical insurance, the announcement on the implementation of the first batch of unique identification in the pilot project is as follows:
1. Deeply promote the pilot work of unique identification
(1) Pilot time. Affected by the new crown pneumonia epidemic, the depth of the unique identification pilot is still insufficient. In order to fully verify the effectiveness of the implementation of the unique identification system, it was decided to extend the pilot period of the unique identification system to December 31, 2020. During the pilot period, enterprises can upload, maintain and update relevant data to the unique identification database of medical devices, and all relevant parties can share application-related data through the unique identification database, and medical institutions can actively explore the connection application of unique identification and medical device management, clinical application, medical insurance settlement and other fields. (2) Pilot varieties. On the basis of the existing pilot varieties, enterprises are encouraged to include more varieties, especially the products in the first batch of national high-value medical consumables key governance list (hereinafter referred to as the "list") issued by the General Office of the National Health Commission.2.Second, the implementation of the first batch of products is well organized
(1) Implementation time. After the end of the pilot, the implementation of the first batch of unique identifiers will be fully launched, and the implementation time of the first batch will be adjusted from October 1, 2020 to January 1, 2021. (2) Varieties to be implemented. In order to implement the relevant requirements of the State Council's reform of high-value medical consumables, on the basis of the notice of the State Food and Drug Administration on matters related to the implementation of the first batch of unique identification of medical devices (No. 72 of 2019) 9 categories and 64 varieties, 5 high-risk Class III medical devices such as intra-auricular prosthesis, spinal inter-body fixation/replacement system, absorbable surgical hemostatic materials, penile prosthesis, and implantable drug infusion equipment in the "List" are included in the scope of the first batch of varieties for the implementation of unique identification, and the specific product catalog is shown in the annex. Encourage the first batch of other varieties in the list to implement unique identification. The Notice of the State Food and Drug Administration on Matters Related to the Implementation of the First Batch of Unique Identification of Medical Devices (No. 72 of 2019) remains unchanged except for the adjustment of the implementation time and varieties.3.Relevant requirements.
1. The drug administration of all provinces (autonomous regions and municipalities) should attach great importance to the implementation of unique identification, actively carry out publicity and training on the unique identification policy, do a good job in guiding the pilot work, find out the situation of the first batch of enterprises implementing unique identification within the administrative area as soon as possible, formulate corresponding work plans in combination with the actual work, and organize the first batch of implementation work within the jurisdiction. 2. From January 1, 2021, the first batch of medical device registrants to implement unique identification will carry out product coding, data upload and maintenance in strict accordance with the relevant requirements of the "Rules for Unique Identification System for Medical Devices", and shall be responsible for the authenticity, accuracy and completeness of the data. 3. All relevant parties involved in the implementation of the unique identification of medical devices should make full use of the unique identification to carry out their work, and focus on promoting the application of the unique identification in the fields of medicine, medical treatment, and medical insurance. During the implementation process, all parties shall promptly analyze and summarize, and promptly report important issues and suggestions, to ensure the smooth progress of the implementation of unique identification.
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