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Chuanghui Medical Attends Training on "Planning and Updating of CE Regulations in Overseas Markets"


2019Year 3Month 22Day, and MDRThe medical device regulations will come into effect in May 2020. In order to assist the company in establishing a quality management system that meets the requirements of laws and regulations and promote the effective development of the company's quality management work, the training of "CE Regulations Planning Update for Overseas Markets-EU Chapter" organized by Changzhou Medical Device Industry Association was held in Changzhou Wujin Holiday Hotel, and the company's laws and regulations department personnel participated in the training activities.

The training was delivered by Mr. Yu Zeli, an independent senior regulatory consultant who has worked for HP Medical and TUV.、BSIProduct service company, has excellent communication skills and rich audit experience. In the process of training and explanation, Mr. Yu connected with reality and used humorous language. From a series of measures that affect how to deal with the new regulations brought about by Britain's upcoming Brexit, it gives a unique explanation on issues such as product classification, authorized agencies, clinical data, manufacturer responsibility, and database establishment. It emphasizes how and what manufacturers should do at each time node, and the importance of preparation before the regulations come into effect, such as language, reading ability, human resources, reliable European generation, etc. In the afternoon, we had a question and discussion session, and the atmosphere was lively, which benefited everyone a lot.

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