Among the series of activities of Medical Device Innovation Week, the Forum on Intelligent Manufacturing and Intelligent Regulation of Medical Devices was held on September 11th in Suzhou. The forum established the Intelligent Manufacturing and Intelligent Supervision Branch of China Medical Device Industry Association, and was honored to invite 7 senior experts to share the latest trends and technologies of intelligent manufacturing and how to successfully achieve digital transformation.
In response to the demand of many enterprises, the Intelligent Manufacturing and Intelligent Supervision Branch of China Medical Device Industry Association was formally established. Through a show of hands, Wu Haoran, General Manager of Crown Information Technology (Suzhou) Co., Ltd. was finally elected as the vice president of the first Intelligent Manufacturing and Intelligent Supervision Branch, and Yu Lin, Chief Engineer of the National Medical Devices Industry Technology Innovation Alliance, was elected as the secretary-general of the first Intelligent Manufacturing and Intelligent Supervision Branch. After the formal establishment of Intelligent Manufacturing and Intelligent Supervision Branch, it will continue to recruit members at all levels, including experts and enterprises, and those who have the intention and meet the conditions are welcome to apply. The purpose of the subcommittee is to serve and promote the development of intelligent manufacturing and intelligent supervision in the medical device industry, and to put forward suggestions, measures and product industry standards for related work. For enterprises that want to carry out digital transformation, the subcommittee can provide all kinds of services related to supply chain management and manufacturing process.
The traditional regulatory model for the production of medical device companies is usually time-consuming, such as regular on-site inspections as well as sample sampling, and the process is not flexible enough to respond in a timely manner to new technologies and innovations in the market. Therefore, with the development of the medical device industry, some countries and regions are gradually introducing more flexible and digitalized regulatory methods to improve efficiency and adaptability.
Dr. Cao Yun, a researcher-level senior engineer of Jiangsu Food and Drug Supervision and Information Center, made a comparative analysis: smart regulation is mainly for high-risk products, and instead of going to the site as in the traditional regulatory model, it can be carried out remotely and through live broadcasting. Such an approach has four benefits:
1. the burden on enterprises can be reduced.
2. data can be updated in a timely manner, and can be guaranteed in terms of accuracy and effectiveness.
3. Remote supervision is carried out by means of Internet digitization, and problems found can also be reminded to the enterprise segment in time.
4. Tax management based on pre-calculus is also helpful.
UDI, as the unique identification of medical devices, is also an important tool within smart regulation. Most of the enterprises have completed the UDI assignment in the process of smart regulation. Mr. Liu Liang, Senior Engineer of the State Drug Administration Information Center, shared the use of the national medical device database platform based on UDI, which can strengthen the transparency, completeness and timeliness of product traceability data through UDI-assigned products, and facilitate the supervision and tracing of products by the regulatory authorities. If you want to know more about UDI, you can pay attention to the online classroom of Medical Device Innovation Network, and the related content of ‘Unique Identification of Medical Devices (UDI) Compliance and Implementation Training Session’ will be uploaded to the related forum video for you to learn.
The necessity of Digital Transformation Smart Manufacturing in Medical Device Enterprises
National policy level view:
At present, the national policy guides all industries to digital transformation.2022 May 1, the implementation of the “supervision and management of the production of medical devices” mentioned: medical device registrants, filers, commissioned production enterprises should establish a record management system to ensure that the records are true, accurate, complete and traceable. Encourage medical device registrants, filers, entrusted production enterprises to adopt advanced technical means to establish information management system to strengthen the management of the production process. (Chapter III, Article 33)
Enterprises themselves look at the situation:
The aggravating trend of population aging in China is gradually eroding the demographic dividend once enjoyed by the manufacturing industry, leading to rising production costs, cost reduction has become an urgent task for the survival and development of enterprises. To meet this challenge, companies need to take active measures to enhance their competitiveness to ensure that manufacturing is faster and more flexible.
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Post time: Sep-25-2023