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Industry Inion

    Small and medium-sized medical device manufacturers will face opportunities and challenges

    By the medical equipment in China's internal and external situation, the government has begun to strengthen supervision from the legal aspects, the new version of "medical device supervision and management regulations" has been released. After China has revised the "Medical Device Registration Management Measures", "in vitro diagnostic reagents registration management approach", "medical device specifications and labeling regulations", "medical device production supervision and management approach" and "medical device management supervision and management approach" And other five regulations, for the "Regulations" the implementation of escort. This for medical enterprises, means that we should pay more attention to the quality of equipment.

    In addition, some high-equipment, pharmaceutical industry, a leading position, there are monopolies suspect foreign enterprises, the state issued a document requiring the hospital in the acquisition of equipment, a reasonable choice, and gradually expand the procurement of domestic equipment. In the low-end equipment, standardize the production order, the equipment classification. At the same time additional medical device adverse event monitoring, re-evaluation, recall and other systems. This means that only adapt to new changes, strengthen their own business management, will be in this "shuffle" in a firm foothold, in order to achieve greater development.


     

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E-mail: sdkejiaxun@126.com

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