The new mode of medical device supervision is determined

The revised "Regulations on the Supervision and Management of Medical Devices" was formally promulgated on March 31 and will come into effect on June 1, 2014. Tong Min, Director of the Department of Medical Device Supervision of the State Food and Drug Administration, said that the new regulations have clarified the regulatory model for "pre-registration and post-production licenses" for medical devices, and stipulated that manufacturers can have registration certificates for medical device products. Apply for a medical device production license. This change in the regulatory model will not only further encourage corporate innovation, but will also reduce the company's investment before the product is registered.

Accelerating the pace of approval of new products The most striking aspect of the new regulations is the change in registration procedures. Previous regulations adopted the "production license first, product registration" model. Although it played a positive role in protecting product quality, manufacturers often caused corporate personnel, venues, and equipment in the process of obtaining production licenses and completing product registration. The idleness has increased the burden on enterprises, and some scientific research institutions have restricted their enthusiasm for research on medical device innovation because they cannot obtain production licenses.

The new regulations make it clear that the state implements classified management of medical devices in accordance with the degree of risk. The first category is the low risk level, the implementation of conventional management can guarantee its safe and effective medical equipment, such as Bandages, cotton swabs, etc.; the second type is a medical device that has moderate risks and needs strict control and management to ensure its safety and effectiveness. Such as sphygmomanometers; the third category is a higher risk, need to take special measures to strictly control management to ensure its safe and effective medical devices, such as pacemakers, stents, disposable sterile syringes.

Xu Jinghe, director of the legal department of the State Food and Drug Administration, said that the most prominent adjustment in the revised regulations was to appropriately reduce the number of administrative licenses, reduce the 16 administrative licenses in the original regulations to nine, and abolish three administrative licenses. Promoted the reform of the administrative examination and approval system.

Xu Jinghe said that the three cancellations included the abolition of the approval of the second category of clinical trials for medical devices, the cancellation of medical device approvals for the development of medical devices, and the cancellation of compulsory safety certification for the third category of medical devices; there were also three changes to the registration of the first category of medical device products. Instead of filing, the non-substantive changes in the second and third categories of medical devices were changed from registration to registration, and the second type of medical device license was changed to record. There is also a reduction in the scope of examination and approval of clinical trials for Class III medical devices.

According to Xu Jinghe's interpretation, industry insiders said that this means that the rate of entry of innovative medical device products to the market is expected to accelerate, and medical device companies can focus on product development and marketing, without having to spend upfront resources on investment in production plants, which will greatly ease the medium and small The financing pressure of enterprises is conducive to innovation.

In addition to encouraging innovation, the highlight of the new regulations is a substantial increase in the penalties for penalties for violations of medical devices. For the production and management of medical devices without permission, a fine of up to 20 times the value of the goods was stipulated, and within five years, the relevant responsible person and the enterprise's application for a medical device permit shall not be subject to punishment.

“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 in the international community, and strict inspections are strictly conducted. It will help low-level SMEs withdraw from the market, which will help industry leaders in the industry to increase industry concentration. Listed companies are expected to capitalize on capital strength to win in industry mergers and acquisitions.

Since last year, the medical device industry has seen an active merger and acquisition trend. 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.

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