Medical Device Supervision Regulations will be issued

The person in charge of the Department of Medical Device Supervision of the State Food and Drug Administration has revealed on the opening day of the medical device manufacturing enterprise that "the Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the "Regulations") will be promulgated in the near future." The relevant regulations and normative documents of production, operation and use cover all aspects of the medical device industry chain.

2014 was an important year for the transformation of the medical device industry. It is understood that the draft of the "Regulations" for soliciting opinions in February was approved by the State Council's executive meeting. On the one hand, the State Food and Drug Administration has accelerated the formulation and revision of the relevant Regulations and Regulations, and on the other hand, it has carried out special rectification operations nationwide to rectify and maintain the market order. Market analysts believe that the introduction of the "Regulations" will promote the integration of the entire industry, and the medical device industry will usher in a merger and acquisition boom.

According to the calculation of the China Medical Device Industry Association, the industrial output value in 2013 was around 400 billion yuan. According to conservative estimates, the output value of medical devices will reach 450 to 500 billion yuan by 2015. As of the end of 2013, there were nearly 16,000 medical device manufacturers.

"In China's medical device companies, there are about 20 companies with operating income exceeding 1 billion yuan." Zhao Yixin, president of the China Medical Device Industry Association, pointed out that the overall level of the medical device industry is at a lower level internationally. According to her introduction, the development of China's medical device industry mainly has three problems: First, less investment in research and development, low level of innovation, and less core technology; Second, national brands are in a relatively weak position in the market; Third, the development of medical devices in the upstream industry. There are major constraints, especially the basic industries of the country, such as materials, electronics, machinery, and energy, which are important factors that affect its development.

According to the person in charge of the Medical Device Supervision Department of the Food and Drug Administration of China, the development of China's medical device industry started relatively late. At present, the overall size of the industry is relatively small, and the industrial foundation is relatively weak. Some companies violate the rules and regulations by mistake, and some products have safety risks. Give the public security risks. In December 2009, the former State Food and Drug Administration issued five regulatory documents for the medical device industry, including the “Quality Management Practice for Medical Device Manufacturing” (hereinafter referred to as “the Code”), and it began on January 1, 2011. It is implemented in the national sterile and implantable medical device manufacturing enterprises.

It is reported that medical equipment is divided into three categories according to the degree of risk: The first category is medical equipment that can ensure its safety and effectiveness through routine management, such as Bandages and cotton swabs; the second category is the safety and effectiveness of the medical devices. Controlled medical devices, such as sphygmomanometers; the third category refers to the implantation of the human body, to support, maintain life, or have a potential danger to the human body, such as pacemakers, stents, disposable sterile syringes.

The person in charge revealed that the General Administration of Pharmacy and Drugs will also issue a notice to comprehensively promote the implementation of the “Regulations” and stipulate that by the end of 2015 all third-tier medical device manufacturers must meet the requirements of the “Specifications”; by the end of 2017, all medical device manufacturers Must meet the "code" requirements.

The relevant personage of Johnson & Johnson told the reporter “This is a good thing to standardize the company. We hope the government will strictly strengthen supervision.”

Industry sources pointed out that due to the different levels of existing medical device manufacturing companies, the full implementation of a series of policies will promote the structural adjustment and industrial upgrading of the medical device industry, and enhance the quality and safety of medical devices in China. The medical device industry will also enter the climax of mergers and acquisitions.

In fact, since the beginning of last year, there has been an active merger and acquisition trend in the medical device industry. According to WIND statistics, of the 19 listed medical device companies in Shanghai and Shenzhen, seven companies, including Qianshan Pharmaceutical, Yuyue Medical, and Sannuo Biological, have discussed or are undergoing mergers and acquisitions. In addition, the acquisition of medical device companies by listed companies has also begun to increase, such as the acquisition of medical institutions by Jiashitang, and the acquisition of children's hearing equipment companies by Yabao Pharmaceutical.

“With the increase in the number of medical institutions and the currently tilting of medical reform policies toward primary medical care, the biggest beneficiaries must have a medical device industry.” Chen Xueli, chairman of Weigao Group, told the “Economic Information Daily” reporter that this is also an important market for the medical device industry. factor.

Shanghai Securities Research Report pointed out that the medical device industry will gradually enter the climax of survival of the fittest, mergers and acquisitions, industry leaders will benefit from the improvement of industrial concentration, and listed companies are expected to win the industry mergers and acquisitions with their capital strength. Equipment manufacturers with strong technological development capabilities and high added value products are expected to achieve faster growth.

Currently in the secondary market, listed companies in the medical device industry are very popular with the capital. WIND statistics show that according to Shenyin Wanguo's industry classification, currently among the 19 medical device listed companies, the price-to-earnings ratio (PE, TTM) is more than 50 times as high as 14 and far exceeds the average price-earnings ratio of Shanghai and Shenzhen cities. Among them, the price-earnings ratios of listed companies such as Libang Instrument, Baolaite, Guanxi Bio, Shangrong Medical, and Jiu'an Medical are all over 100 times.