[Depth] Will the medical machinery industry face “shuffle” in 2016?

Recently, the National Medical Device Supervision and Management Work Conference was held in Beijing. Food and drug supervision and party style and clean government construction are still one of the main contents of the meeting. The detailed summary and future deployment of medical device supervision and management work is worthy of attention. The official website of the Food and Drug Administration.)

At the beginning of the new year, will the General Administration of Food and Drugs transfer the focus of work from drug registration supervision to medical devices? What is the current status of China's medical device industry ? Is the water in the medical machinery industry “deep and mixed”? Will the medical machinery industry face a reshuffle? The author wants to talk about personal opinions here.

Looking back at 2015, what happened in the medical machinery industry?

In terms of policies and regulations, the National Bureau issued the "Opinions on Reforming the Approval System for Drug Medical Device Evaluation and Approval", "Measures for Drug Medical Device Flight Inspection", and "Medical Device Classification Rules" in 2015. The "Opinions" opened the curtain of the reform of the review and approval system for pharmaceuticals, so that product safety, effectiveness, quality controllability and international standards are further integrated, and the quality of drug review and approval is improved. The "Measures" states that food and drug supervision and management The department has the right to inspect the development, production, operation, use and other places of the inspected unit at any time for inspection. The unit under inspection shall not refuse or evade; and the "Rules" combines the experience accumulated in the classification of medical devices, after in-depth investigation and extensive solicitation. Comments, some of the terms and classification decisions have been refined.

In terms of industry layout, there are 14,151 medical device manufacturers in the country, which is less than 1,000 in 2014. A small number of small and low-level enterprises have withdrawn from the historical stage, and the government's decentralization has helped a number of advantages. The company is lightly loaded and expands its product structure and marketing channels through independent innovation and capital operation, and deploys a large health industry. Many enterprises have made great progress in economic growth through transformation, restructuring, and mergers and acquisitions. At the same time, the situation of “distribution, chaos, and small” in China's medical machinery industry is gradually being broken.

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