Medical Device Supervision and Administration Bill announced
On September 6, the State Council promulgated the Regulations for the Supervision and Administration of Medical Devices (Revised Draft) (hereinafter referred to as the “Regulationsâ€), and established a product recall system to re-define the classification definitions for three types of devices and restrict the content of medical device advertisements.
Just a few days ago on August 21st, Vice Minister Wang Guoqiang of the Ministry of Health was interpreted by the industry and the workshop as being the highest level of doubt from China: In a meeting, he asked whether many domestic and foreign medical device companies are right. When the products that were sold out were retrospectively surveyed and questioned simply for profit, no one answered.
Three years ago, Zheng Jun, the former director of the State Food and Drug Administration, who was sentenced to death, was punished by the law for seeking compensation for medical devices and drug approvals. Three months ago, Zhang Jingli, the deputy director of the Bureau of Food and Drug Administration, was “double-regulationâ€. The workshop also said that he was also involved in bribery from medical device companies.
The expert evaluation draft said that the "Regulations" only set up a safety valve for dual supervision of price and quality. Whether it can effectively end chaos and provide safe and effective equipment for large consumer groups in the entire industrial chain is the key to the problem.
Industry sources said that medical equipment in large hospitals is currently "used for sickness." Ventilators, pacemakers, and defibrillators suddenly malfunction in the course of salvaging patients; extra-corporeal surgery involves the withdrawal of extracorporeal circulation machines; renal dialysis machines are Sudden failure during hemodialysis for the patient; failure of the anesthetic machine during surgery; rupture of the instrument during endoscopic surgery; rupture of the centrifugal bowl during autologous blood recovery, blood loss... A device manager working in the hospital told Nandu : "These are not new things."
It is understood that a large number of medical equipment and products ranging from tens of millions to as small as a few dollars have caused many medical disputes because of quality problems. An attorney from the lawyers told Nandu that he often encounters cases of personal injury caused by medical device failures in the practice of lawyers.
Foreign-funded products hold the right to speak in price formulation, and instrument after-sales problems have become one of the problems in the industry. According to reports, giants such as GE, Siemens, and Philips each have more than 3,000 employees, mainly sales personnel, while after-sales service personnel account for only a small portion—Siemens has sold 15,000 medical devices in China. product.
The harm caused by product quality is shocking. It is understood that this year in Beijing, after sampling 139 batches of medical devices, it was discovered that 12 batches of products failed to pass the comprehensive judgment. Major unqualified items include weight, pathogenic bacteria, body tightness, compressive strength, etc. More than half of the unqualified product list for quality inspections of medical devices announced this time was disposable medical devices involving disposable sterile syringes (with needles), medical absorbent cotton, disposable sterile vaginal dilators, and Sex bags, etc.
Rent-seeking problems are spreading in this industry. The “gray shady†of this industry has penetrated into the three major operating links of production, circulation and use. As an example, experts say that domestic C T has been developed for 10 years, and multinational companies still occupy 70% of the market share. More than three years ago, the Siemens bribery case involved the Chinese medical department. The recent case of Johnson & Johnson’s bribery case also revealed a signal that foreign companies that have always been strictly regulated have gradually become bribery-hit areas, including GE and Philips’ giants who are allegedly involved in commercial bribery. The 20% of profits in the medical device industry have been used for commercial bribery. Indisputable planning in the industry.
The 850 billion yuan in new medical reforms is becoming a big cake for Chinese and foreign medical device companies. According to the “10th Five-Year Plan†development plan, by 2010 China's total medical device output value will reach 150 billion yuan, and its share in the world's medical device market will account for 5%.
Although 70% of the domestic high-end medical device market has been occupied by multinational companies, domestic companies are gradually breaking the monopoly of foreign companies, and companies such as Shenzhen Mindray, Jiangsu Yuyue, and Shandong Xinhua have been engaged in the production of medical device products.
As of August 31, the semi-annual report of domestic pharmaceutical listed companies has been announced. In the field of medical device segmentation, the revenue of listed companies maintained a growth rate of around 20%; the market value of the rising star in the medical device industry was huge, and the total market value of 8 listed companies was 48.5 billion.
In the domestic medical device market, about 80% of the CT market, 90% of magnetic resonance equipment, 90% of ultrasonic equipment market, 85% of inspection equipment market, 90% of electrocardiograph market, 80% of medium and high-grade monitor market, 90 The market for high-grade physiological recorders is monopolized by multinational corporations. Among them, the market for medical devices such as nuclear magnetics, MR, and CT is mainly held in the hands of GE, Siemens and Philips. The average price of a foreign brand C T is about 13 million yuan, while that of the high-end brand is between 20 million and 30 million yuan. Domestic purchasing power for high-end medical equipment is strong. Siemens' latest Flash Hyun-speed CT currently sells more than 100 units worldwide and China has more than 20 orders.
Just a few days ago on August 21st, Vice Minister Wang Guoqiang of the Ministry of Health was interpreted by the industry and the workshop as being the highest level of doubt from China: In a meeting, he asked whether many domestic and foreign medical device companies are right. When the products that were sold out were retrospectively surveyed and questioned simply for profit, no one answered.
Three years ago, Zheng Jun, the former director of the State Food and Drug Administration, who was sentenced to death, was punished by the law for seeking compensation for medical devices and drug approvals. Three months ago, Zhang Jingli, the deputy director of the Bureau of Food and Drug Administration, was “double-regulationâ€. The workshop also said that he was also involved in bribery from medical device companies.
The expert evaluation draft said that the "Regulations" only set up a safety valve for dual supervision of price and quality. Whether it can effectively end chaos and provide safe and effective equipment for large consumer groups in the entire industrial chain is the key to the problem.
Industry sources said that medical equipment in large hospitals is currently "used for sickness." Ventilators, pacemakers, and defibrillators suddenly malfunction in the course of salvaging patients; extra-corporeal surgery involves the withdrawal of extracorporeal circulation machines; renal dialysis machines are Sudden failure during hemodialysis for the patient; failure of the anesthetic machine during surgery; rupture of the instrument during endoscopic surgery; rupture of the centrifugal bowl during autologous blood recovery, blood loss... A device manager working in the hospital told Nandu : "These are not new things."
It is understood that a large number of medical equipment and products ranging from tens of millions to as small as a few dollars have caused many medical disputes because of quality problems. An attorney from the lawyers told Nandu that he often encounters cases of personal injury caused by medical device failures in the practice of lawyers.
Foreign-funded products hold the right to speak in price formulation, and instrument after-sales problems have become one of the problems in the industry. According to reports, giants such as GE, Siemens, and Philips each have more than 3,000 employees, mainly sales personnel, while after-sales service personnel account for only a small portion—Siemens has sold 15,000 medical devices in China. product.
The harm caused by product quality is shocking. It is understood that this year in Beijing, after sampling 139 batches of medical devices, it was discovered that 12 batches of products failed to pass the comprehensive judgment. Major unqualified items include weight, pathogenic bacteria, body tightness, compressive strength, etc. More than half of the unqualified product list for quality inspections of medical devices announced this time was disposable medical devices involving disposable sterile syringes (with needles), medical absorbent cotton, disposable sterile vaginal dilators, and Sex bags, etc.
Rent-seeking problems are spreading in this industry. The “gray shady†of this industry has penetrated into the three major operating links of production, circulation and use. As an example, experts say that domestic C T has been developed for 10 years, and multinational companies still occupy 70% of the market share. More than three years ago, the Siemens bribery case involved the Chinese medical department. The recent case of Johnson & Johnson’s bribery case also revealed a signal that foreign companies that have always been strictly regulated have gradually become bribery-hit areas, including GE and Philips’ giants who are allegedly involved in commercial bribery. The 20% of profits in the medical device industry have been used for commercial bribery. Indisputable planning in the industry.
The 850 billion yuan in new medical reforms is becoming a big cake for Chinese and foreign medical device companies. According to the “10th Five-Year Plan†development plan, by 2010 China's total medical device output value will reach 150 billion yuan, and its share in the world's medical device market will account for 5%.
Although 70% of the domestic high-end medical device market has been occupied by multinational companies, domestic companies are gradually breaking the monopoly of foreign companies, and companies such as Shenzhen Mindray, Jiangsu Yuyue, and Shandong Xinhua have been engaged in the production of medical device products.
As of August 31, the semi-annual report of domestic pharmaceutical listed companies has been announced. In the field of medical device segmentation, the revenue of listed companies maintained a growth rate of around 20%; the market value of the rising star in the medical device industry was huge, and the total market value of 8 listed companies was 48.5 billion.
In the domestic medical device market, about 80% of the CT market, 90% of magnetic resonance equipment, 90% of ultrasonic equipment market, 85% of inspection equipment market, 90% of electrocardiograph market, 80% of medium and high-grade monitor market, 90 The market for high-grade physiological recorders is monopolized by multinational corporations. Among them, the market for medical devices such as nuclear magnetics, MR, and CT is mainly held in the hands of GE, Siemens and Philips. The average price of a foreign brand C T is about 13 million yuan, while that of the high-end brand is between 20 million and 30 million yuan. Domestic purchasing power for high-end medical equipment is strong. Siemens' latest Flash Hyun-speed CT currently sells more than 100 units worldwide and China has more than 20 orders.
Power Plant Spare Parts generally including the pressure parts, casting parts, electronic parts, auxiliary equipment,etc.
Serrated Finned Tube,Welding Finned Tube,Header Collector Tube,Boiler Auxiliaries Collector
Jinan Yuanda Power Equipment Co.,Ltd. , https://www.ydboilerpart.com