According to the latest authoritative statistics, in the high-end and large-scale medical device market in China, foreign-invested enterprises account for more than 80% of products, and domestic brands have low market share, especially high-end image products and high-end consumables. In the face of the weak industry status, tightening market supervision will become a breakthrough in quality improvement. The reporter recently learned that the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft)" (hereinafter referred to as the "Regulations") reviewed and approved by the State Council executive meeting in February this year will soon be implemented; the corresponding supporting regulations "Quality Management Regulations for Medical Device Production" (hereinafter referred to as " The Code will also be released later, gradually covering all types of medical device manufacturers, achieving full coverage by the end of 2017, and the industry system management will soon be formed. High-end products are monopolized Medical equipment, sounds strange and professional, but when it comes to heart stents, beauty products and other products, it feels very close to life. Behind the fact that most consumers don't know much about it, the medical device industry is developing very fast. According to statistics, medical equipment has become one of the most active and fastest-growing industrial fields in China, with an average growth rate of about 20%, much higher than the national economy and the pharmaceutical industry average. The country has formed a number of industrial clusters such as the Pearl River Delta, the Yangtze River Delta, and the Beijing-Tianjin-Bohai Bay. China has become the third largest medical device market in the world after the United States and Japan. According to data from the Ministry of Industry and Information Technology, in 2013, the total industrial output value of medical equipment enterprises above designated size was 343.8 billion yuan, a year-on-year increase of 17.3%. By the end of 2013, there were more than 15,000 production companies nationwide and more than 170,000 second- and third-class medical device companies. The development is fast and not fake, but looking at the international market, the overall development level of medical equipment in China is moderately low. “Technical innovation and results transformation ability is weak, key components rely on imports, and high-end products are still based on imitation and improvement.†Zhao Yixin, president of China Medical Device Industry Association, pointed out that the high-end products on the market, such as CT and MRI, are high-end. Medical medical imaging products are still from a few developed countries such as the United States, Germany, and Japan. They possess advanced technology and are the leaders in the development of the global medical device industry. "At present, China's overall medical device industry R&D investment accounts for 3% of sales revenue, while the foreign average is 15%." Zhao Yixin admits that the main reason for the lack of R&D investment is that the individual scale of China's medical device industry is small. The output value of the 40 largest medical devices in the US accounts for 20% of the global medical device industry output, while there are about 16,000 manufacturing companies in China. The output value only accounts for about 5% of the global medical device industry. It is recommended that enterprises should set their own positions, focus on marketable products and enhance their ability to resist risks. Regulatory technical regulations are becoming stricter "After the promulgation of the "Regulations", according to its regulatory requirements for medical devices, we will issue departmental regulations, including medical device registration, production, operation, use, adverse event monitoring and other supervision and management methods." National Food and Drug Administration, Medical Device Supervision The person in charge of the department said that in order to cooperate with the most stringent and comprehensive supervision system, the relevant regulations and normative documents of the Regulations are being revised and improved, and a relatively complete supervision system is formed. In addition, at the technical level, medical device manufacturers must meet the requirements of the Code. At present, sterile and implantable medical devices have been produced in accordance with the Code. “Before the end of 2015, the third category of medical devices needs to organize production according to the “Specifications†and cover all enterprises at the end of 2017.†The person in charge said that this is a mandatory technical requirement imposed by the government on enterprises. For production enterprises, A production quality management system should be established in accordance with all the requirements of the Code. Regulatory authorities are gradually “overweighting†the specifications for the medical device industry. Recently, the State Food and Drug Administration has deployed a five-month special action for rectifying medical devices, focusing on rectifying false registrations, illegal production, illegal operations, exaggerating publicity, and using unlicensed products. It is reported that in the future, strengthening post-listing supervision will become the focus of medical device industry management. Next, we will carry out special inspections on the production of aseptic and implantable medical devices with the focus on comprehensively implementing the “Regulationsâ€, standardize the behaviors of business use, strengthen the supervision and inspection of high-risk medical device operation behaviors, and improve the adverse event monitoring system. Organize key monitoring and product quality supervision and inspection. 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Medical Device Regulations will implement stricter regulatory techniques
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