Medical equipment set up safety valve remediation industry behind the chaos

Li Keqiang, Premier of the State Council, recently chaired the State Council executive meeting to deliberate and approve the Regulations on the Supervision and Administration of Medical Devices (Revised Draft). The meeting pointed out that ensuring the safety and effectiveness of medical devices is of great significance for maintaining human health and life safety, improving the quality of life, and promoting industrial upgrading.

"There are doctors, living and living, and being old-fashioned" are the three major livelihood topics of concern to the people. Among them, as an important support point for constructing a medical system, the medical device industry is receiving more and more attention. As a small-capacity industry, medical devices are not as attractive as industries such as infrastructure and finance. However, the market scale has exceeded 210 billion yuan in 2001 from 17.9 billion yuan in 2013. China's medical device industry has shown tremendous growth potential, and some institutions even It is predicted that the market size will reach 340 billion yuan by 2015.

Behind the great situation, there are hidden problems. On the one hand, compared with 42% of the total size of the medical market in the world, the proportion of medical devices in China is still very small. Domestic medical equipment cannot fully meet the needs of the domestic market. Large-scale high-end medical equipment mainly relies on imports, and there is still a big gap with the world's medical equipment industry. On the other hand, in recent years, from large to tens of millions, as small as a few dollars. Medical equipment and products, because of quality problems have led to many medical disputes: some large hospitals often use medical equipment, and ventilators, defibrillation pacing monitors, etc. suddenly fail during the rescue of patients; In vitro surgery, the extracorporeal circulation machine stops...

Medical equipment set up safety valve remediation industry behind the chaos

What is even more distressing is that the rent-seeking problem has spread in this industry, and the “gray shady” has penetrated into the three main business processes of production, circulation and use. The management of strict foreign companies has gradually become a hard-hit area for bribery, and 20% of the profits in the medical device industry have been used for commercial bribery. This is an unspoken rule in the industry.

The Regulations on the Supervision and Administration of Medical Devices (Revised Draft) reviewed and approved by the State Council executive meeting will enable the supervision of medical devices to be fully covered from all aspects of registration, production and circulation, and provide a safe and effective way for a large consumer group in the entire industrial chain. The device demonstrates the country’s determination to completely rectify the chaos in the medical device industry.

“The revised draft further improves the classification management according to the risk level of medical device products, raises the threshold for high-risk products, and simplifies the entry procedures for low-risk products.” The risk management concept is used to highlight high risks through the “pressureful and loose” approach. The supervision of product manufacturers and the gradual improvement of the medium and low-risk product manufacturers will help to further implement the quality responsibility of medical device manufacturers, and promote the structural adjustment and industrial upgrading of the medical device industry.

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