Key events for the medical device industry in 2025
01
Intensive landing of concentrated procurement
The fifth batch of consumables for national procurement was officially opened for bidding in December last year. The price of a single set of cochlear implant consumables has dropped from an average of over 200000 yuan to around 50000 yuan, while the winning price of peripheral vascular stent consumables is generally around 3000-4000 yuan, with a significant decrease compared to the past. According to the National Healthcare Administration, it is expected that the selection results of cochlear implants will be available around March 3, 2025. The selection results of peripheral vascular intervention consumables are planned to be implemented in May 2025. Among the seven major consumables under the guidance of the Among the seven major consumables under the guidance of the National Medical Insurance Bureau, bids have been opened for Fujian ligation clip, Jiangxi biochemical reagents, Guangdong ultrasonic cutter head, Zhejiang breast rotary needle, Anhui Swollen mark Jia Gong, Henan coronary special balloon, and Hebei vascular intervention, and the relevant selected results will be successively landing in 2025, bids have been opened for Fujian ligation clip, Jiangxi biochemical reagents, Guangdong ultrasonic cutter head, Zhejiang breast rotary needle, Anhui Swollen mark Jia Gong, Henan coronary special balloon, and Hebei vascular intervention, and the relevant selected results will be successively landing in 2025. According to the Notice on Strengthening Regional Cooperation and Improving the Quality and Expansion of Medical Centralized Procurement in 2024 issued by the National Healthcare Administration, the centralized procurement of high-value medical consumables should focus on varieties with inflated prices, representative significance, and strong public reactions. Provincial alliance centralized procurement with the necessary conditions should be upgraded to national alliance centralized procurement. It can be foreseen that based on the existing provincial alliance centralized procurement; multiple new national joint procurement of consumables may emerge in 2025. Regarding the implementation of the results of centralized procurement, the National Healthcare Administration and the National Health Commission announced 10 specific measures in December last year, covering the medicines and consumables into the hospital, use, monitoring and other aspects of centralized procurement drugs. These measures will be implemented in the implementation stage of various centralized procurement by 2025, including: starting from the third month of the implementation of the results of each batch of centralized procurement, organizing a round of problem investigation on the entry of selected drugs and consumables into medical institutions in the region, and urging medical institutions that have not yet completed the entry procurement to complete the entry of selected drugs and consumables into hospitals as soon as possible; Regularly report provinces and varieties with significant delays in procurement progress, high proportion of non-selected drugs and consumables procurement, etc.
02
Policies and Regulations
Security upgrade+stricter supervision
Consumables traceability code rolled out nationwide, price monitoring mechanism upgraded
Starting from January 1, 2025, the country will comprehensively promote strict supervision on the “code”.
For pharmaceutical consumables companies, traceability codes can also help real-time monitoring of the production, transportation and sales of pharmaceutical consumables, and timely detection and treatment of problems. Enterprises can also query terminal prices to avoid negative impacts on production enterprises caused by prices lower than the online price. Once regulatory authorities discover quality issues with pharmaceutical consumables, they can quickly locate the problematic batch and circulation status through traceability codes, facilitating timely recall and handling. The seamless integration between the healthcare department and the healthcare settlement service through traceability codes can effectively prevent fraudulent activities such as the return sale, substitution sale, and duplicate sale of healthcare drugs and consumables.
Direct settlement and accelerated advance payment, improving the payment environment in the pharmaceutical and equipment industry
As of now, many regions across the country have implemented direct medical insurance settlement for centralized procurement of drugs and consumable. According to statistical data from various regions and information disclosed by the National Healthcare Administration, the payment cycle for drug consumption has been significantly shortened as a result. The coverage of direct medical and consumable healthcare settlement is expected to further expand by 2025.
National Healthcare Administration、 The National Health Commission mentioned in the Notice on Improving the Mechanism of Centralized and Quantity based Procurement and Implementation of Pharmaceuticals that the focus will be on centralized procurement varieties, promoting unified settlement on provincial platforms, and exploring the expansion to other varieties. Recently, Wenchang District in Hainan Province has launched relevant pilot projects to include non-centrally purchased consumables from public hospitals in its jurisdiction in the direct settlement category.
The pre-payment system of healthcare fund was implemented in November last year, which can help designated medical institutions alleviate the pressure of medical expenses, including turnover expenses for medical expenses such as drug and medical consumables procurement.
According to the official schedule, designated medical institutions voluntarily apply for advance payment from the healthcare department in the pooling area in early January of each year.
The schedule for mutual recognition of inspection results has been determined, and the 2025 target has been announced
According to the “Guiding Opinions on Further Promoting Mutual Recognition of Inspection and Testing Results of Medical Institutions” issued by the National Health Commission and seven other departments, by the end of 2025, all closely connected medical consortia (including urban medical groups and county-level medical consortia) will achieve mutual recognition of all projects among medical institutions within the medical consortium, and more than 200 projects will be recognized among medical institutions in various cities.
As the scope of mutual recognition of results continues to expand, various unnecessary examination and testing items will continue to be reduced, further compressing the living space for excessive diagnosis and treatment.
Important regulations are about to be implemented: medical devices, pharmaceutical representatives
In August 2024, the Comprehensive Department of the National Medical Products Administration publicly solicited opinions on the draft of the Medical Device Management Law of the People’s Republic of China. The Draft Opinion consists of eleven chapters and 190 articles, covering various aspects of medical device development, production, operation, and use, as well as standards, classification, vigilance, recall, and more. At present, the ‘Draft Opinion’ has received feedback and is expected to be officially implemented in 2025.
In addition, the newly amended Regulations for the Supervision and Administration of Medical Devices will come into effect on January 20, 2025.
On November 28, 2024, the National Medical Products Administration issued the Administrative Measures for Pharmaceutical Representatives (Draft for Comments), which will come into effect from the date of publication, and the Administrative Measures for the Filing of Pharmaceutical Representatives (Trial)will be simultaneously abolished. At present, the draft opinions have been solicited from six departments including the Ministry of Public Security, the National Health Commission, the State Administration for Market Regulation, the National Healthcare Administration, the State Administration of Traditional Chinese Medicine, and the National Bureau for Disease Control and Prevention. The deadline for implementation is approaching.
The draft for soliciting opinions once again clarifies the definition of pharmaceutical representatives and for the first time specifies the qualifications for the appointment of pharmaceutical representatives. Article 10 of the draft makes it clear that the pharmaceutical representative should have a bachelor’s degree or above in medicine, pharmacy or related majors (or intermediate or above professional and technical titles), in addition, should have clinical theoretical knowledge and practical experience in drugs, or have experience in drug research and development, production, inspection, quality management and other positions, and have a grasp of the pharmacology and toxicology of the promoted drugs, the function of the primary care or indications, combination of drugs, adverse reactions, contraindications and precautions and other knowledge, and have been trained and assessed by the drug marketing licensee. Knowledge of pharmacology and toxicology of the promoted drug, its functional main indications or indications, combined use of drugs, adverse reactions, contraindications and precautions, etc., and qualified by the training and assessment of the holder of the listed drug license
03
Industry Development Chapter:
Market recovery+innovation going global
On December 31, 2024, CICC released a research report, said that although by the medical industry consolidation continues, the slow progress of equipment procurement, IVD and high consumption set of factors such as the impact of medical device listed companies in recent quarters have certain performance disturbance, but also observed that the marginal impact of these factors is gradually weakening or repair improvement, 2025 segmentation track or is expected to benefit from product upgrades and overseas exports.
According to SDIC Securities, the bidding scale of medical equipment industry in the first half of 2024 was about 55 billion yuan, down by about 35% year-on-year, of which the bidding scale of medical imaging declined by about 45% year-on-year, and the bidding scale of life information field declined by 50% to 60% year-on-year.
At present, the procurement demand delayed by the equipment renewal has been released one after another, according to Joinchain statistics, as of November 17 last year, the medical field equipment renewal procurement intention budget totaled 17.7 billion yuan, of which the amount of budget and the number of projects of the medical equipment renewal procurement budget in November increased significantly, and the policy stepped into the landing stage.
Everbright Securities expects this equipment renewal to pull 60 billion yuan of medical equipment procurement scale, medical equipment manufacturers or enter the performance of high growth range.
In the domestic market environment of gradual involution, going overseas to dig for gold has become an important layout of many mechanical enterprises. According to Yizhuangshusheng collation, in the first half of 2024, China’s medical device trade continued to maintain an export surplus, of which medical consumables, IVD exports were up more than 6%. It is expected that the annual medical device exports will be higher than last year, after three years to realize the export trade growth.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
Source：Yizhuanshusheng
Translated & edited： Bradyknown
