China Medical Device Regulatory

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The first member of the Shanghai Food and Drug Administration Food and Drug Linsen Yong regulatory functions from the adjustment of planting interventional medical device industry

Shanghai May 8, 2013 / PRNewswire PRNewswire / - May 23-24, interventional medical devices implanted in the Third China Summit will be held in Shanghai.

In recent years, whether it is food, drugs or medical devices have a large part of unsatisfactory quality management, product quality and safety of frequent accidents. Through the analysis of these quality accident case, where the market has undergone product quality and safety issues, both with producers intentionally or unintentionally quality management consciousness, lack of management capacity are directly related.

In 2012 Shanghai medical device manufacturers quality system assessment as an example: 2012 quality system assessment applications throughout the year the number of 624, one-time assessment through the 324, accounting for only 51.2% of total applications; wherein: the first application quality system assessment 281 , an examination through 129, accounting for 46% of total applications; quality system four or five years after the re-registration of products, changing production sites, production license renewal application for such re-assessment of the quality system has 343 times, disposable examination passed only 194, accounting for 56% of total applications.

Sen Yong, Shanghai Food and Drug Administration Medical Device Security Management Services is at medical commissioner, food and drug regulatory functions from the Adjustment of planting interventional medical device industry to help enterprises in the industry to grasp the implant interventional medical devices for the process of market penetration and opportunities challenges. He will attend this year's May 23-24 at the Sheraton Shanghai Hongkou Hotel on the third interventional medical devices implanted in China Summit .

Sen Yong pointed out: there is a life-cycle industry, and follow these rules: 30% -100% increase for the period of enlightenment; increase 30% -10% for the period of growth; increased 10% and below maturity; negative value for the recession, etc. four stages. Medical device industry also has these characteristics, a major measure of marked sales growth rate. In terms of the medical device industry, sales growth of 50% -100% (or more) belong to the Enlightenment period, the sales growth rate of 50% -20% are growing, sales growth rate of 20-5% for the maturity, 5% or less belong recession. Stability in the industry to do the following suggestions for reference:

1, the product quality should be guaranteed, systems must be standardized so controllable risk.

2, sources of raw materials for implants, the procurement process, validate links, etc. to do reality.

2012-05-28 10:15:27 by bluebanana

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