Recently, Tianjin Binhai New Area Food and Drug Administration commissioned SGS, the world's leading inspection, appraisal, testing and certification organization, to carry out quality system for 33 high-risk medical device manufacturers such as aseptic, phytosanitary (input) in Tianjin Binhai New Area. Review and conduct quality inspections on products found to be problematic. Tianjin Binhai New Area Food and Drug Administration has continuously explored ways and means to improve the level of equipment supervision. This time, the professional strength of the international authoritative third-party testing and certification organization aims to realize the differentiation and specialization of medical device supervision and help medical device enterprises to improve. Quality compliance.
Binhai New Area is a medical equipment industry gathering area in Tianjin. High-tech medical equipment manufacturers and high-risk products have successively obtained production licenses and product registrations of the International Food and Drug Administration. The industry has developed rapidly. There are 169 medical device manufacturers in the new district, including 64 Class III medical device manufacturers, accounting for 57% of the city's high-risk enterprises, involving nearly three types of high-risk medical device products, product quality risks are increasing, and medical devices Supervision has the characteristics of strong professionalism and complicated disciplines. Therefore, the current medical equipment supervision in the new district is facing unprecedented challenges. The quality improvement and safety protection of medical device enterprises are in need of high-level, comprehensive inspection, testing, certification and other technical services to support. SGS has become a reliable professional partner of the Binhai New Area Food and Drug Administration with its rich service experience and technical strength in the global medical device quality management field.
In the cooperation, SGS senior experts in the field of medical devices closely cooperated with Binhai New Area Food and Drug Administration, and both parties conducted a one-month on-site review of medical device manufacturers in the region. The review includes the production technical requirements, supplier audit, production environment compliance and other factors, covering all aspects of the company's production quality compliance. The professional, standardized and meticulously reviewed by the SGS expert group has been approved by the new district drug regulatory bureau. Agree. Subsequently, the two sides conducted a comprehensive analysis of the quality standard management of the high-risk medical device manufacturing enterprises of the Binhai New Area Food and Drug Administration, and provided and implemented the response plan, requiring the enterprises to fully prepare for the review, identify problems during the review, and actively improve after the review. Really improve the production quality management norms of enterprises from the practical operation level. Next, Tianjin Binhai New Area Food and Drug Administration and SGS will actively explore cooperation in a wider field and deeper level, and contribute to the improvement of medical equipment management level in Tianjin Binhai New Area, promote product quality improvement and domestic and international trade development. .
As a leading provider of test certification for the medical device and in vitro diagnostic industry, SGS has established a network of medical device specialists and test labs in more than 35 countries. With a familiarity with local regulations and markets, and the ability to connect to SGS's global service network in a timely manner, SGS can provide customers with a one-stop service covering test certification, market access, third party audit, evaluation and system. In China, SGS's service network covers key provinces and cities in medical equipment, with branches in Jiangsu, Guangdong, Beijing, Zhejiang, Shanghai and Shandong to ensure that the needs of enterprises can be responded quickly. At the same time, SGS professional medical care The device expert technical team can control the entire process of the company's audit process, helping you quickly gain access to the medical device market.
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