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 has been reduced by more 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 A small number of small and low-level enterprises have withdrawn from the historical stage, and the government’s decentralization has helped a number of advantages.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.
The shortcomings behind the gratifying results
While the medical machinery industry is developing rapidly, we have to pay attention to the shortcomings behind the rapid development. False registration and declaration, illegal production, illegal operation, exaggeration of propaganda, use of unlicensed products and other illegal and illegal activities are brewing and fermenting.
Regarding the registration of threshold entry, the number of “notices on the publication of non-registration approvals†issued by the General Administration of Food and Drugs is often alarming. There are only 490 acceptance numbers that will not be registered on the 22nd of this month, and 402 acceptance numbers will not be registered on the 15th. A large number of unregistered documents reflect that China's medical machinery industry is not researching enough on its products, and its attitude is not serious enough. The company also reported that it is a matter of ignorance and thoroughness. The author hereby advises that the rectification of drug registration data fraud has been The medical equipment market has sounded the alarm, it is time to think about the future development!
In the event of adverse reactions after medical access, the number of reports of medical device adverse events in the country reached 260,000 in 2014, and the average number of people reported reached 198. Among them, 98 cases of death adverse events were reported, and more than 40,000 cases of serious injury incidents were reported, accounting for 15.5% of the total number of suspicious adverse events reported, an increase of 18.6% over 2013. This also refers to any harmful events that occur or may occur in the normal use of qualified medical devices that are not related to the intended use of medical devices, and the serious consequences of accidents that occur in medical devices that enter the market illegally. Imagine it.
Is the water in the medical machinery industry “deep and mixed�
First of all, I have to mention the "kickback" issue. The main sales channel for medical devices is from the hospital. I have also purchased medical device products for my parents in the hospital. I remember that the doctor recommended the products of Bayer in foreign countries. At that time, for the health of parents, I would naturally choose "expensive." "," "good", I believe that most patients and their families are the same way of thinking. The "rules" of "rebate" still exist today, and the "red envelope" of the operating room has not been completely eliminated. As a manufacturer, under the influence of interests, the cost reduction and even the non-compliance and unqualified operations will naturally occur from time to time. .
Second, unqualified products are mixed into the market. In order to evade taxes and evade supervision, unscrupulous merchants often deliver goods to the door. Many medical institutions purchase medical device products from irregular channels in order to make them cheap. As a result, many unqualified products have flowed into the market, bringing supervision. A lot of difficulties. There are also some products that are sold directly to salespeople who are easily deceived. The elderly have become their main target, and the news of being deceived is almost everywhere.
Will the medical machinery industry reshuffle at this time?
Since the supervision of drug registration and approval by the Food and Drug Administration in 2015, the industry rectification has been in full swing. From the number of drug registration approvals that have been actively withdrawn and the comprehensive disclosure of data fraud by the Food and Drug Administration, we can see that The Pharmacy's determination to rectify the pharmaceutical industry. The food and medical equipment under the jurisdiction of the General Administration of Food and Drugs, I do not know if you feel that food safety issues have been frequently exposed in recent days, such as "the detection of poppy shells in foods operated by 35 catering service units", so think about it in recent days. The National Medical Device Supervision and Management Work Conference was held. The author speculates that the General Administration of Food and Drugs may reform the medical machinery industry with the opportunity of drug registration and rectification.
Although the potential damage of medical devices is relatively straightforward, there is no direct drug (of course, different levels of medical devices are different), but because of the low barriers to entry, the large number of enterprises, and the uneven size, if not It is not known whether a certain time will be rectified and whether it will evolve into a situation in which drug registration data is now fraudulent. And is it now a fake? It is also hard not to be suspicious. This month, the General Administration announced the “National List of Medical Device Inspectorsâ€. This is not a big first step. I believe that in the next work in 2016, I will get an answer.
The Spring Festival is coming soon. The author is looking forward to the "food, medicine, medical device industry" under the supervision of the "promoting development and strict requirements" of the General Administration of the People's Republic of China. It can show a new spirit and escort for the life and health of our people!
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