Demand for basic medical device market rises

In order to understand thoroughly the implementation of the newly revised "Regulations on the Supervision and Management of Medical Devices" and the supporting regulations, difficulties encountered and problems encountered, the State Food and Drug Administration concluded a special symposium in Shanxi province on April 10th.

The relevant officers of the Food and Drug Administration had a detailed understanding of the medical device approval and filing, supervision, inspection capacity building, and operation of the company's quality management system. They also carefully listened to opinions and suggestions put forward by the company in registration and quality management.

Some analysts told reporters that in the future, the grassroots institutions in China will have a greater demand for medical devices, and the market potential in this area is relatively large.

Will strictly exercise the license

According to reports, the officials from Shanxi, Hebei, Shaanxi, Gansu, Qinghai, Ningxia, Xinjiang, and other provinces and districts reported on the implementation of the newly revised Regulations on the Supervision and Management of Medical Devices and supporting regulations, and proposed related work. Comments and suggestions.

After the meeting, Jiao Hong, the deputy director of the Food and Drug Administration, visited the Taiyuan Food and Drug Administration, the Shanxi Provincial Medical Device Testing Center, and some medical device manufacturing companies. They learned about the medical device examination and approval filing and supervision, and the detection capacity development. The operation of the enterprise quality management system carefully listened to the opinions and suggestions of the enterprise.

The State Food and Drug Administration believes that following the promulgation and implementation of the newly revised "Regulations on the Supervision and Administration of Medical Devices," the next step, local governments will continue to strengthen the implementation and enforcement of new laws and regulations, and combine the regional characteristics with the characteristics of the industry to focus on new targets. The implementation and training of the regulations and related supporting documents shall be strictly exercised in accordance with the law, and shall exercise the powers of recordation and supervision, and shall not be allowed to devolve statutory matters without authorization.

In the implementation of the level of supervision responsibility, the province must be divided into units as a reasonable division of administrative power, to build a provincial, city and county level of clear-cut rights and responsibilities clear working system, effectively configure the limited resources, the quality of risk control. Analyze the risk characteristics, industrial conditions, and regulatory requirements of the jurisdiction, and comprehensively promote the construction of a supervision team and technical support system to comprehensively improve the quality and safety control and level of medical devices.

It is understood that the supervision department will further intensify supervision and law enforcement efforts, investigate cases, and expose violations of the law, and carry out in-depth medical equipment "five rectification" special operations to look back, solid development of decorative colored plain contact lenses, condoms and in vitro diagnostics Try concentrating on rectification and severely punish violations of laws and regulations.

Strong demand from the grassroots market

According to public statistics, the size of China's medical equipment market is around 180 billion yuan, which is less than one-fifth of the pharmaceutical market. However, from the standpoint of growth potential, China's medical devices are expected to enter an era of great leapfrog development and have better growth prospects than drugs.

According to Zhao Zhen, an analyst of Zhuochuang Information & Pharmaceutical Industry, after the implementation of the new regulations, the medical device industry has a clearer and more standardized norm, which is conducive to improving the overall concentration of the medical device industry. "These impacts will certainly show up gradually because there are still more medical equipment companies in China than pharmaceutical manufacturers. It is estimated that there are 15,000 or so large and small enterprises with at least several thousand kinds of products."

Zhao Zhen told the reporter of “Daily Economic News” that “the average domestic output value of each company is less than 10 million yuan. After implementing the new regulations, the average output value of related companies will rise accordingly.”

From the perspective of enterprises, Zhao Zhen estimated that the leading position of the medical industry in Jiangsu, Zhejiang, Shanghai and Beijing and Tianjin will be further strengthened, and good medical equipment resources will flow more to the above areas.

It is worth noting that, in terms of specifications concerning medical devices, future regulatory agencies should also have follow-up actions, including optimization, including registration and supervision.

"Now the ratio of domestic medicine and medical care is 1:0.4 to 1:0.5. It is estimated that after the implementation of the new regulations for a period of time, the proportion of medical care will also be improved." Zhao Zhen told the reporter of "Daily Economic News".

Moreover, in the future, China's lower-level institutions will have greater demand for medical devices, and the market potential in this area is relatively large. China's medical device resources will further sink, which is beneficial to the development of practical and popular products, and household-type medical devices will also have greater room for development.

In addition to the possible impact of the above-mentioned domestic medical device industry, from another perspective, international import and export may also be affected in certain ways, especially in terms of imports, including medical equipment products with large import shares, such as diagnosis and treatment equipment, rehabilitation supplies, and dental equipment. Affected by the implementation of the new regulations will be relatively obvious.