China's medical device industry is tightening supervision, leading companies will benefit

This is a set of data given by Yu Qingming, deputy of the National People's Congress and chairman of China Medical Devices Co., Ltd. at the two sessions in 2018. Under such a huge market potential, how to ensure product quality and public safety is a common problem faced by the regulatory authorities and enterprises.

Up to now, most domestically produced medical devices are in the imitation stage, and there is a certain gap between R&D and production and multinational pharmaceutical companies. Take Medtronic as an example, its global research and development costs are as high as 2.2 billion US dollars, and also invest in high capital and time costs in research and development, as well as Omron, a leading health care management company.

Previously, the National Medical Device Supervision and Management Work Conference was held in Beijing. Xu Jinghe, member of the party group and deputy director of the State Drug Administration, deployed five key tasks in the medical device industry in 2019.

The first is to strengthen innovation and lead the way to improve the quality of development. It is necessary to actively promote the development of innovative medical devices, solidly promote innovation in clinical trial management, and steadily promote the pilot system of registrants.

The second is to strengthen risk management and build a safe bottom line. It is necessary to highlight the assault of inspection, the targeting of sampling, the systematicness of monitoring, the effectiveness of governance, and the deterrent of punishment.

The third is to strengthen the system construction and enhance the regulatory capacity. It is necessary to improve the regulatory system, technical standards system, and technical support system, and promote informationization supervision.

The fourth is to strengthen the implementation of responsibilities and enhance the synergy of supervision. It is necessary to compact the responsibility of the main body of the enterprise, implement the responsibility for territorial management, and consolidate the responsibility for departmental supervision.

The fifth is to strengthen scientific supervision and improve the level of supervision. It is necessary to promote regulatory scientific research, innovate regulatory operational mechanisms, and strengthen international exchanges and cooperation.

With the development of the medical device industry, the variety of products has increased, and it has also brought a new regulatory model. Some analysts pointed out that the supervision of medical devices will become stricter in the future and will undoubtedly eliminate a large number of small and medium-sized enterprises. However, for leading enterprises, it is undoubtedly a major positive, the industry will have a series of integrated mergers and acquisitions, the concentration will be increasingly improved.

◆ Industry iteration

Mercury sphygmomanometer will withdraw from the historical stage

On February 21, the State Food and Drug Administration issued the "Notice of the National Medical Device Supervision and Sampling Results (No. 1)", said that the surgical gown, aspartate aminotransferase assay kit, non-invasive automatic blood pressure monitor (electronic blood pressure) The products of the five batches of 130 batches (sets) were subjected to quality supervision and sampling, and a total of 12 batches of products were not in compliance with the standards.

Among them, a non-invasive automatic measuring sphygmomanometer produced by Omron (Dalian) Co., Ltd., the deflation does not meet the standard. In addition to a non-invasive automatic measurement sphygmomanometer, the identification requirements did not meet the standard.

According to Omron, the State Drug Administration found that the sampling inspection did not meet the standards. In fact, only the technical requirements were recorded incorrectly, and the quality of the product itself was not involved. The performance of the product complies with relevant regulatory requirements, and there are no problems with performance indicators, safety and effectiveness.

In fact, the replacement of mercury sphygmomanometers with electronic sphygmomanometers has become an irreversible trend. As early as October 2013, representatives of 92 countries and regions including China finally signed the Convention on Mercury in Mercury. The Convention requires the production and import and export of traditional mercury sphygmomanometers and thermometers after 2020. Mercury products.

At the same time, for the medical field, the World Health Organization and the “Non-Clean Health Organization” immediately launched the “Achieve Mercury Free Health Care Plan by 2020”, calling for the phase-out of mercury-containing thermometers and mercury-containing blood pressure measuring devices by 2020.

Professor Wang Wen of the National Cardiovascular Center said in an interview that traditional mercury-containing sphygmomanometers have some subjective human factors, and there are some differences in measurement values, such as the influence of environmental noise, the speed of the doctor during deflation, and the reading. Preferences, etc. can cause errors in blood pressure values, and the advantage of an electronic sphygmomanometer is the ability to accurately measure instantaneous changes in blood pressure.

As an emerging medical alternative, electronic sphygmomanometers have been updated over three generations. In November 2016, the global cumulative sales of Omron's home sphygmomanometer exceeded 200 million units. In the Chinese market, Omron's electronic sphygmomanometer has a 50% market share.

According to the "China Guidelines for the Prevention and Treatment of Hypertension 2010", it is clearly indicated that the upper arm automatic or semi-automatic electronic sphygmomanometer can be accurately measured using the proven (BHS British Hypertension Society, AAMI American Medical Device Testing Association and ESH European Hypertension Society). blood pressure.

With the continuous development of China's medical device industry and the continuous improvement of mercury-free medical equipment, mercury sphygmomanometers will gradually withdraw from the historical stage, and the upgrading of mercury-free medical equipment will become the consensus of the whole society.

◆Regulatory strictness

Leading companies welcome the policy

With the continuous improvement of the living standards of the people and the growing awareness of health care, home electronic sphygmomanometers have become a must-have for families, and it is very important for the monitoring of patients with hypertension.

According to the data of the “Food and Drug Regulatory Statistics Annual Report of 2017” by the State Food and Drug Administration, in 2017, the drug supervision department investigated and handled 17,000 medical device cases, with a value of 180 million yuan, a fine of 430 million yuan, and confiscation of illegal income of 19.691 million. Yuan, banned 161 unlicensed businesses, smashed 31 counterfeit and fake dens, ordered 98 enterprises to suspend production and business suspension, 13 licenses were revoked, and 62 were handed over to the judiciary.

In fact, the domestic electronic sphygmomanometer market has a lot of chaos: low-end sphygmomanometers are low-cost and low-quality, and the measured blood pressure and real value are very different, which will mislead consumers and even delay treatment. Therefore, experts suggest that consumers should try to use large brands of products when purchasing.

In June 2018, the State Food and Drug Administration launched the revision of the Regulations on the Supervision and Administration of Medical Devices, strengthened the supervision of the listing and operation and use of medical devices, and formulated a series of regulatory and regulatory documents.

This includes a rigorous investigation of network operations and sales activities, focusing on the core objective of ensuring the safety and effectiveness of medical devices, and the regulatory authorities to speed up the review and approval system for scientific evaluation, and to fine-tune the full life cycle of medical devices.

At present, China's medical device industry is actively making structural adjustments. As a leading company in the industry, Omron not only has many advantages, but also promotes the overall development of the industry and enhances the overall level and core competitiveness of the entire electronic sphygmomanometer industry, and is moving towards a mercury-free industry.

In addition, from another perspective, China's medical device industry upgrade, the industry's entry barrier will suddenly increase, it will be difficult to have new companies to re-enter in the future, which is undoubtedly a major for the leading enterprises that have been rooted in the industry.