Revisión de los principales acontecimientos en la industria de dispositivos médicos en 2024
Source: China Industrial Economic Information Network
The national procurement of consumables continues, the unique identification of medical devices is implemented, and innovative medical devices covering multiple fields are continuously approved… In 2024, the medical device industry has achieved a series of important leaps and developments. This article will review the major events in the medical device industry in 2024.
"China Medical Device Standard Management Annual Report (2023)" was released
On February 1, 2024, the "China Medical Device Standard Management Annual Report (2023)" released by the State Food and Drug Administration showed that in 2023, the National Standards Committee approved 52 medical device national standard project plans and 117 medical device industry standard project plans; approved the release of 28 medical device national standards and 131 medical device industry standards.
The official pushes a series of measures to support the development of innovative drugs and equipment
On April 17, 2024, the Beijing Municipal Medical Insurance Bureau and other nine departments jointly issued the "Beijing Measures to Support the High-quality Development of Innovative Medicines (2024)" (hereinafter referred to as the "Measures"). The Measures propose 32 measures in eight aspects, including R&D of innovative drugs and devices, clinical trials, review and approval, manufacturing, circulation and trade, and clinical applications, covering innovative pharmaceutical manufacturers, circulation companies, medical institutions, and the financial insurance industry. In terms of the review and approval of innovative drugs and devices, the Measures clearly state that a key project management mechanism will be implemented for innovative pharmaceutical companies, with "one product, one policy", early intervention, and full-process guidance in registration and application, licensing, and other aspects.
Results of the fourth batch of national procurement of consumables are implemented
From May to June 2024, the results of the fourth batch of national centralized procurement of consumables will be officially implemented in the market, involving artificial lenses and sports medicine medical consumables, with a market size of approximately 15.5 billion yuan.
Implementation of unique identification of medical devices
From June 1, 2024, the "Announcement on Doing a Good Job in the Third Batch of Implementation of Unique Identification of Medical Devices" jointly issued by the National Medical Products Administration, the National Health Commission, and the National Medical Insurance Administration will be officially implemented, and 103 types of medical devices will be included in the scope of implementation of unique identification, including ultrasonic surgical equipment, laser surgical equipment and accessories.
The requirements for the temporary import and use of medical devices urgently needed in clinical practice in medical institutions have been issued and implemented
On June 19, 2024, the National Medical Products Administration and the National Health Commission issued the "Requirements for the Temporary Import and Use of Medical Devices Urgently Needed in Clinical Practice in Medical Institutions". This requirement applies to medical institutions that temporarily import and use medical devices urgently needed in clinical practice for patients, which have been marketed abroad but no similar products have been approved for marketing in China. It does not include equipment that should be included in the configuration licensing management of large medical equipment. Among them, clinical urgent need refers to the need for clinical prevention and treatment of serious life-threatening diseases when there is no effective treatment or prevention method in China.
my country has 1,978 medical device standards
According to the announcement of the National Medical Products Administration, as of July 9, 2024, there are 1,978 medical device standards, including 272 national standards and 1,706 industry standards; 269 mandatory standards and 1,709 recommended standards, which basically cover all professional and technical fields of medical devices.
The illegal and irregular rate of online sales pages of medical devices has been effectively reduced
On July 10, 2024, the news released on the website of the National Medical Products Administration showed that after years of efforts, the illegal and irregular rate of online sales pages of medical devices has dropped from 3.2 per 100,000 in 2018 to 1.3 per 100,000 in 2023, which has effectively safeguarded the safety and legitimate rights and interests of the people's online purchase of medical devices and promoted the standardized, orderly and high-quality development of the online sales market of medical devices.
After the National Medical Insurance Administration's public inquiry, the company announced a price reduction
On August 16, 2024, the National Medical Insurance Administration issued a public inquiry letter, requiring Xinmai Medical to publicly respond to the price, sales, ex-factory price and terminal price difference of Castor stents, whether the price was deliberately raised, and other issues. The Castor stent was independently developed by Xinmai Medical and is the world's first branched aortic stent approved for marketing. It was launched on the market at the end of the third quarter of 2017. The public inquiry letter from the National Medical Insurance Administration shows that after preliminary verification and inquiry of public information, the ex-factory price of Castor stent (200mm length) is about 50,000 yuan, but after being supplied to medical institutions by agents, the price exceeds 120,000 yuan. After the initial interview, Sinomed Medical proposed a price adjustment plan, but did not change the fact that the price difference significantly exceeded the necessary range. On August 23, Sinomed Medical announced that in light of the actual situation of the industry, the company decided to significantly reduce the excessive price increase in the circulation link without basically affecting the ex-factory price and profit, and adjust the terminal price of Castor stent and other series of main thoracic stent products to about 70,000 yuan or less, with a price reduction of about 40% or more.
Establish four key support areas to remove the "blocking points" and "difficulties" in industrial development
On September 13, 2024, the State Council Information Office held a series of press conferences on "Promoting High-quality Development". Li Li, Director of the National Medical Products Administration, introduced the support for the development and listing of innovative drugs and medical devices. He said that the National Medical Products Administration deepened the reform of the review and approval system and implemented "early intervention, one policy for one enterprise, full guidance, and research and review linkage" for key varieties to accelerate the pace of listing of innovative drugs and medical devices. The press conference also pointed out that the four key support areas of "artificial intelligence, new medical biomaterials, high-end medical imaging and medical robots" were established to remove the "blocking points" and "difficulties" in industrial development.
New progress in the collection and application of drug and consumable traceability information
On October 29, 2024, the National Medical Insurance Administration held a national release event on the collection and application of medical insurance drug and consumable traceability information: As of October 28, 32 provincial medical insurance information platforms have fully carried out the collection of drug and consumable traceability codes, and have collected 3.127 billion drug and consumable traceability code data, involving 296,800 designated medical institutions and 497,200 designated retail pharmacies. More than 60% of medical institutions and 99% of pharmacies have carried out the collection of traceability codes. The National Medical Insurance Administration has made it clear that it will continue to promote the application of drug and consumable traceability codes in the future, so that every link of drug and consumables from production, transportation to sales can be monitored and recorded in a timely manner, and big data analysis can be used to timely discover problems, trace the source, and take measures to reassure enterprises and people.
The scale of my country's medical device industry continues to grow steadily
On December 2, 2024, the Medical Device Supply Chain Branch of the China Federation of Logistics and Purchasing released data stating that the market size of my country's medical device industry is expected to exceed 1.2 trillion yuan in 2024, an increase of about 2.2% year-on-year. This is due to the superposition effect of multiple factors such as scientific and technological development, policy support and market demand. As of June 2024, the number of medical device manufacturers in my country has reached more than 32,800, and the annual number of product filings/first registrations is close to 50,000, and the scale of the industry continues to grow steadily.
Innovative medical devices cover multiple fields
As of December 17, 2024, the State Food and Drug Administration has approved a total of 315 innovative medical devices, of which 65 innovative medical devices approved in 2024, domestic products accounted for 71%. These innovative products cover a variety of fields, from high-end medical equipment to new diagnostic equipment, from intelligent equipment to biomaterials.
The fifth batch of national high-value medical consumables centralized procurement was opened for bidding
On December 19, 2024, the fifth batch of national high-value medical consumables centralized procurement (hereinafter referred to as "centralized procurement") was opened for bidding in Tianjin to produce the winning results, including two types of products: cochlear implants and peripheral vascular stents. The price of a single set of cochlear implant consumables (including implants and speech processors) in this centralized procurement has dropped from more than 200,000 yuan to about 50,000 yuan. According to the National Medical Insurance Administration, the winning results of cochlear implants are expected to be implemented around March 3, 2025; and the winning results of peripheral vascular interventional consumables are planned to be implemented in May 2025 due to their many models, various combinations of lengths and thicknesses, and long stocking cycles.
The State Council Executive Meeting deployed: Increase support for medical device innovation
On December 23, 2024, the State Council Executive Meeting deployed relevant measures to deepen the reform of drug and medical device supervision and promote the high-quality development of the pharmaceutical industry. The meeting pointed out that it is necessary to deepen the reform of the entire process of drug and medical device supervision, create an innovative ecosystem with global competitiveness, promote my country's progress from a pharmaceutical power to a pharmaceutical power, and better meet the people's demand for high-quality drugs and medical devices. It is necessary to increase support for the research and development and innovation of drugs and medical devices, play the leading role of standards, and actively promote the use of innovative drugs and medical devices. It is necessary to improve the quality and efficiency of review and approval, speed up the approval and listing of drugs and medical devices urgently needed in clinical practice, and reduce or exempt clinical trials for innovative drugs and medical devices for rare diseases that meet the conditions. It is necessary to improve the compliance level of the pharmaceutical industry with efficient and strict supervision, and support the pharmaceutical industry to expand opening up and cooperation. It is necessary to follow up on policies in medical insurance, medical care, and prices in a timely manner, and work together to promote the high-quality development of the pharmaceutical industry.
