Inspection related price approval, highlighting the value of IVD raw material quality and cost control

On August 14, 2026, the National Healthcare Security Administration officially released the "Guidelines for the Approval of Inspection Medical Service Price Projects (Trial)" (hereinafter referred to as the "Inspection Medical Service Approval Guidelines"), which is the 40th and last batch of medical service price project approval guidelines, marking the basic formation of a unified and standardized medical service price project system nationwide. The guidelines cover major areas such as clinical testing, transfusion and blood type, microbiology and parasites, molecular diagnosis, biochemistry, and immunology, with a total of 662 main items, 114 additional items, and 7 extension items. As a core supplier in the field of in vitro diagnostic (IVD) reagent raw materials, Hubei Xindesheng Material Technology Co., Ltd. believes that this policy adjustment will have a profound impact on the industry, and high-quality and highly stable diagnostic raw materials will play a more critical role under the new price system.

1.  Policy core: Same inspection and same price, pricing not differentiated according to inspection methods

The guidelines for inspection projects adhere to a service-oriented approach, with the core change being the principle of no longer setting up separate main projects based on inspection methodology. Taking glucose testing as an example, in the past, most regions established different price items based on different testing methods such as dry chemistry, enzyme method, and enzyme electrode method. However, the new guidelines unify the "glucose testing fee" and no longer distinguish between testing methods, achieving the same testing and price.

At the same time, the guidelines clearly stipulate that the consumption of basic material resources required for testing, including reagents, quality control solutions, calibration solutions, etc., shall be included in the pricing cost of testing items, and medical institutions shall not charge patients separately. This means that downstream inspection agencies and IVD reagent production enterprises will face further pressure in cost control, and higher requirements will be put forward for the stability, purity, and cost-effectiveness of raw materials.

2. Industry impact: Raw material quality becomes the key to reducing costs and increasing efficiency

Under the new rule of "same test, same price", the fees for inspection items will no longer have price differences due to methodological differences, and the ability to control reagent costs will directly affect the profit margins of medical institutions and reagent manufacturers. This has prompted the entire IVD industry chain to pay more attention to the quality and cost efficiency of upstream raw materials - high-purity and highly stable diagnostic raw materials can help reduce batch differences, lower duplicate detection rates, improve the accuracy and consistency of test results, and thus achieve better economic benefits within the established fee framework.

As pointed out in the guidelines, the in vitro diagnostic reagent market in China has continued to grow in recent years, with a market size of approximately 130 billion yuan by 2025. The standardization and unification of national inspection price items will effectively lead the high-quality development of inspection disciplines and promote mutual recognition of inspection results. In this process, the technical strength and product quality of upstream raw material suppliers will become an important foundation to support the high-quality development of the industry.

3. New Desheng: Using high-quality raw materials to assist the industry in responding to new regulations

Hubei Xindesheng Material Technology Co., Ltd. has long focused on the field of IVD reagent raw materials, deeply cultivating the research and development, production, and sales of core products such as blood vessel additives, biological buffering agents, chemiluminescence reagents, color reagents, enzyme preparations, etc. The company was formerly known as Wuhan Desheng Biochemical, established in 2005. After years of technological accumulation and continuous innovation, it has grown into a core enterprise in the field of IVD reagent raw materials in China.

In response to the industry changes brought about by this policy adjustment, New Desheng's core product system can provide strong support for downstream customers:

Biological buffer series: The company relies on the advantages of chemical synthesis technology to form a matrix of more than 50 products such as Tris, HEPES, MOPS, etc., with a stable purity of over 99%, and can customize indicators according to customer application scenarios. High purity buffering agents provide a stable reaction environment for diagnostic reagents, helping to ensure the accuracy and inter batch consistency of test results.

Enzyme Preparation Series: The company has developed a new generation of high-purity and highly stable enzyme preparations, including key indicator detection materials such as lactate dehydrogenase (LDH), uricase (UO), creatine kinase isoenzyme (CKMB), etc. Enzyme preparations with high activity and stability can effectively enhance the detection sensitivity and specificity of the reagent kit, helping downstream reagent manufacturers achieve better product performance within the established fee framework.

Color developing substrate series: TOOS, MAOS and other products are benchmarked against international standards, with some indicators surpassing them, helping reagents improve detection indicators and reduce background interference.

Blood collection tube additives: Heparin lithium, Heparin sodium, EDTA dipotassium, tripotassium, serum separation gel and other blood sample pretreatment product systems, widely used in clinical laboratory and other fields.

The company has two R&D and production bases in Gedian and Huanggang (70 acres), with an annual production capacity of 5000 tons for all categories. With solid technical strength and a sound quality control system, Hubei Xindesheng was successfully selected as a single champion enterprise in the manufacturing industry of Hubei Province in 2026, marking that the company has reached the forefront of the IVD reagent raw material subdivision track in China.

The release of the inspection project approval guidelines marks a new stage of unified and standardized management of medical service pricing projects nationwide. For the IVD reagent raw material industry, the importance of quality, stability, and cost-effectiveness will be further highlighted. Hubei Xindesheng Material Technology Co., Ltd. will adhere to craftsmanship and quality, continuously increase research and development investment, empower the development of IVD in vitro diagnostics industry with more stable products and more professional technical support, and help the industry achieve high-quality development in the new policy environment.