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Accelerated integration of the medical device industry




The State Food and Drug Administration yesterday (March 17th) held a press conference, announced thatbeginning in mid March in the medical device "national focus for a period of 5 months the five rectification" special action, the focus of remediation medical false registration, illegal production, illegal business, exaggerated propaganda, the use of unlicensed products such as five kinds of behavior. By the industry news, listing Corporation stock prices higher.

Why the State Food and Drug Administration for choosing the expansion of high-pressure strike hard at this time?The State Food and Drug Administration spokesman Yan Jiangying said, at present, generally speaking, our country medical security situation is generally stable good. However, due to China medical devices industrystarted relatively late, the overall size of the industry is small, industrial base is relatively weak, some enterprises illegal acts have occurred, it is necessary to timely launch market supervision situation crackdown.

In fact, in recent years the domestic medical equipment industry is developing rapidly, expanding market capacity,but the overall industrial structure is loose, concentrated in the low technology level.

A domestic listed medical instrument company executives told reporters frankly, at present domestic monitoringmedical development better, especially the export business is growing faster, but the treatment of medical equipment is still short board.

In this context, many industry insiders regulators this round of consolidation as a good industry, it will acceleratethe big companies and the industry concentration.

In fact, the medical device industry integration specification has accelerated in the last year. The reporter understands, the State Food and drug administration has promulgated the "medical device classification rules"(Revised Draft) ", the innovation of medical equipment special approval procedures (Trial)", "medical devicequality management specification (Draft)" and 104 medical device industry standard, on the regulation of medical devices to realize the full coverage from the registration, evaluation, innovation of production, circulation and management each link. In March 4th this year, the State Food and drug administration officials in medicine NPC and CPPCC representatives at the meeting, this year will be on the medical aspects of documents, regulations,rules and regulations to conduct a comprehensive revision.

China Medical Devices Industry Association President Jiang Feng had stated publicly, the introduction of the new policy with the upgrade, the integration trend of medical device industry will be more rapid. At the same time, the medical device industry mergers and acquisitions has intensified, some time ago to diving medical has just announced the acquisition of Huarun late East, and the company recently announced for planning a major reorganization of assets and the suspension.

Multi institutional research reports, the next ten years, from the diagnosis, monitoring, treatment to breakdown in the field of medicine medicine will open a era of intelligent, portable, intelligent development of medical deviceindustry is represent the general trend, the future will be to slow disease related field, in high-end import substitution and mobile intelligent medical extension.

Li Xiaoming analysis says, rectifying the medical device industry has been on, the rectification estimation is combined with the "3 · 15" special action, should not have a significant impact on the industry, "rose might berelated to investors on the medical device industry."

Yan Jiangying further said, "for a period of five months after the end of medical special rectification action, do not represent our rectification closure, can say the campaigns ending, our work is not. The State Food and Drug Administration will also continue to maintain a high pressure situation against medical violation, consolidate ourspecial action results, to further promote the construction of regulations, perfecting supervision mechanism."