The medical device industry is ushering in strict new regulations in history, and it remains to be seen whether it is possible to curb industry chaos.

    In order to cooperate with the "Regulations for the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations"), the State Food and Drug Administration announced on the 1st the newly revised "Administrative Measures for the Registration of Medical Devices", "Regulations for the Administration of Medical Device Instructions and Labels", and "Medical Devices" Five regulations including the Operational Supervision and Administration Measures will be implemented on October 1.

    It is reported that the above-mentioned "Regulations" have been formally implemented since June 1 this year, and my country has also revised medical device supervision regulations for 14 years.

    "The introduction of the new regulations has played a huge role in regulating the development, production, operation, use of medical devices, and strengthening the supervision and management of medical devices." Xia Long, a researcher of China Research Institute and PwC, in an interview with a reporter from China Sankei Shimbun Say.

    At present, the development of my country's medical equipment imports has led to an important factor of "expensive medical treatment". According to statistics, in the top three hospitals, domestic high-end medical equipment accounts for less than 10%, mainly imported equipment from abroad.

    According to the "2013 Blue Book of China's Medical Device Occupation Development" released by the China Pharmaceutical [0.40% Fund Research Report], China's high-end medical devices rely primarily on imports, and imported medical equipment quotations are 50% higher than those in countries of origin such as Europe, America and Japan. 100%. For example, the equipment such as TOMO radiotherapy system is mostly 2.5 million US dollars in Europe, America, Japan and other countries, and China imports more than 5 million US dollars.

    The reporter learned in the interview that in the domestic medical device market, foreign products are in a monopoly position in most of the high-end variety markets, and my country spends hundreds of millions of dollars in foreign exchange each year to import a large amount of medical equipment from abroad.

    Liu Shan, a researcher at the China Business Intelligence Network Industry Research Institute, said that there are currently many small and medium-sized enterprises in the medical device industry. Due to inadequate supervision and inconsistent production standards, some medical devices are three-free products, which seriously infringe on the rights and interests of consumers; in addition, Illegal production by small enterprises has reduced production costs, adopted price wars in the industry, and sold at low prices, resulting in the phenomenon of "bad currencies" expelling "good currencies" in the market.

    At present, my country's medical device industry is characterized by many, small, high and weak. Xia Long said that as of the end of 2013, there were 15,361 medical device manufacturing enterprises across the country, and the scale of the enterprise was relatively small. In 2013, the total output value of the medical device market was 200 billion yuan, and the average output value of each enterprise was about 12 million yuan. Whether it is production or sales, the concentration of the Chinese medical device market is generally low.

    Earlier, the reporter learned in the interview that the reason why foreign high-end medical devices can occupy most of the market in my country is closely related to the lack of innovation in my country's medical device companies.

    Liu Shan suggested that medical device companies should increase investment in R&D, focus on technological R&D and innovation, break through the monopoly of foreign companies in the field of high-end devices, and allow consumers to use high-tech products produced by domestic companies.

    The implementation of the new regulations is only a very favorable external factor for the healthy development of China's medical device industry, and the real problem of improving the medical device industry in China lies in the industry's own efforts, how to innovate, how to occupy the high-end market, and how to export China to developed countries Of medical devices are worthy of consideration and exploration by the entire industry.