32 Provincial-Level Alliance Regions Join: Two Medical Consumable Categories Enter Volume-Based Procurement With a Three-Year Cycle

On November 6, 2026, the Hebei Provincial Healthcare Security Administration issued a notice launching an interprovincial alliance volume-based procurement program for two categories of medical consumables: powered pulse lavage devices and constrained balloon dilatation catheters for peripheral vessels without drug coating.

Hebei is leading the procurement alliance, which covers Beijing, Shanghai, Guangdong, Jiangsu, Zhejiang and other regions. In total, the alliance includes 31 provinces, autonomous regions and municipalities, together with the Xinjiang Production and Construction Corps, for 32 provincial-level alliance regions.

The proposed procurement cycle is three years, calculated from the actual implementation date of the selected results in each alliance region.

All public medical institutions and military medical institutions in participating regions are required to take part. Privately operated medical institutions designated under the basic medical insurance system will participate according to their designated-provider agreements.

The first-year contracted procurement volume will be determined by aggregating the actual demand reported by medical institutions for the coming procurement year.

Separate procurement documents have been prepared for the two categories, numbered LM-HD2026-01 and LM-HD2026-02.

The deadline for feedback is 18:00 on November 15. The procurement remains at the public consultation stage, while the final procurement documents, declaration schedule and final selection results have yet to be announced.

Two Product Categories Cover Surgical Procedures and Peripheral Vascular Intervention

The two categories included in this procurement differ substantially in clinical use and product structure.

The first category is the powered pulse lavage device.

These products generate pulsed fluid flow through powered drive systems and are mainly used for wound irrigation during orthopedic, trauma and other surgical procedures, helping remove blood, tissue debris and other contaminants.

Compared with conventional manual irrigation, powered pulse lavage systems can provide a more continuous and controllable irrigation flow.

The draft procurement document divides these products into two categories: integrated power-driven systems and external equipment-driven systems.

Both must be Class II medical devices, supplied sterile and intended for single use.

For an integrated power-driven system, the product must include a spray tube or tip, gun body including locking ring and trigger, fluid inlet tube, suction tube and power box.

An external equipment-driven product must include a spray tube or tip and fluid inlet tube, with the driving power supplied by external equipment.

Because the two types differ in power configuration, consumable composition and method of use, the procurement establishes separate product categories and quotations for them.

The second category is the constrained balloon dilatation catheter for peripheral vessels.

These products are used in peripheral vascular interventions. They typically incorporate an external constraining structure around the balloon to create a relatively controlled balloon shape and force distribution during inflation, assisting the treatment of stenotic lesions.

A conventional balloon primarily dilates a vessel through overall balloon inflation.

A constrained balloon adds an external structural element. Some products can create segmented or locally restricted expansion patterns, with the aim of improving force distribution during dilatation and reducing unnecessary vessel injury.

The procurement specifically covers peripheral vascular constrained balloon dilatation catheters without drug coating.

Drug-coated constrained balloons are excluded. The category should also not be treated as equivalent to all conventional peripheral balloons or cutting balloons.

According to Frost & Sullivan’s Blue Book on the Current Status and Development Trends of the Specialty Balloon Industry for Vascular Intervention, as of January 2024, 17 peripheral specialty balloon products had been approved in China, including eight domestic and nine imported products.

These covered multiple categories including cutting balloons, scoring balloons, constrained balloons and related drug-coated balloons.

Among peripheral constrained balloons, products that had obtained registration in China included Medtronic’s Chocolate™, Batai Medical’s Matrix Super, Changde Medical’s EF-Rhine and Hengrui Hongyuan’s Cixpak.

These figures reflect the product landscape at that time and do not represent the list of companies participating in the current procurement.

Whether an individual product qualifies for this procurement will still depend on its valid registration certificate, specific structure and the final procurement rules.

Companies Quote by Product Category, With Maximum Valid Declaration Prices

Both procurement programs use companies as the quotation entities.

Powered pulse lavage devices are quoted separately according to the two power configurations, while peripheral constrained balloons are declared under the corresponding product category.

Under the draft documents, each company may submit only one price within the same product category.

A declared price may not exceed the maximum valid declaration price for that category; otherwise, the quotation will be considered invalid.

Companies must also commit not to submit prices below cost.

The quoted price must cover expenses including product design, manufacturing, packaging, transportation, distribution, testing, taxes, acceptance, after-sales services and associated services.

Supporting tools provided free of charge before the procurement must continue to be provided free of charge after a company is selected.

The powered pulse lavage procurement also establishes a representative product quotation rule.

For integrated power-driven products, a product containing two spray tubes or tips serves as the representative configuration for quotation.

Companies that do not manufacture that configuration must convert the price of their own product into the representative-product price using the specified product-feature conversion coefficients before competing with other suppliers.

The selection rules for both categories involve first-round quotation rankings, limits on the number of shortlisted companies and an anchor price mechanism.

According to the draft documents, shortlisted companies whose first-round valid declaration prices are no more than 1.5 times “Anchor Price ①” may qualify for selection under Rule 1.

The documents also establish Rule 2 and Rule 3, providing additional quotation and selection pathways.

Another notable element is a mechanism designed to control price dispersion.

If a company’s quotation falls below the specified “Anchor Price ②,” its allocated volume ratio will be reduced to zero, and it will not occupy a shortlist quota.

As a result, a company’s quotation affects not only whether it qualifies for selection but also the amount of contracted procurement volume it may ultimately receive.

After selection, companies must confirm their contracted procurement volumes according to demand reported by medical institutions and the applicable volume-allocation rules.

For peripheral constrained balloons, the draft procurement document provides that when three or fewer companies are selected within the same product category, selected companies may receive 100% of the demand volume specifically reported for their own products by medical institutions.

The remaining procurement volume can then be independently allocated by medical institutions among selected suppliers.

For powered pulse lavage devices, the selection ranking of integrated power-driven products can also affect the allocation of procurement volume for certain external equipment-driven products.

The relevant rules allow medical institutions to allocate volumes among eligible selected companies.

All of these provisions remain part of the draft documents for public consultation.

The final maximum valid declaration prices, detailed anchor price calculations and number of selected suppliers will be subject to the final procurement documents.

Multiple Domestic Peripheral Specialty Balloons Have Already Entered the Market

In recent years, the range of domestically produced peripheral vascular interventional consumables has continued to expand.

In addition to conventional balloon dilatation catheters, cutting balloons, scoring balloons, constrained balloons and drug-coated balloons have gradually entered the Chinese market, forming different technical approaches for lesion preparation and treatment.

Constrained balloons alter the balloon’s expansion pattern through an external structure and are often used in clinical situations requiring more controlled vessel preparation.

Their designs differ from conventional balloons and also require evaluation of deliverability, dilatation performance, vessel injury and post-procedural outcomes.

According to the 2024 Frost & Sullivan industry report, domestically marketed peripheral constrained balloons included Batai Medical’s Matrix Super, Changde Medical’s EF-Rhine and Hengrui Hongyuan’s Cixpak, with the relevant registrations obtained in 2023.

Among imported products, Medtronic’s Chocolate™ entered the Chinese market relatively early.

Some regions have previously included peripheral vascular balloon dilatation catheters in volume-based procurement programs.

In relevant alliance procurement results announced in 2025, conventional balloons and high-pressure balloons were tendered separately by product type, involving companies including Dingke Medical, Bade Medical, Kesaier Medical and Bomai Medical.

The latest Hebei-led procurement treats peripheral constrained balloons as a separate procurement category, distinguishing them from the scope of previous procurement programs covering general peripheral balloons.

For companies holding registrations for these products, the final pricing, reported demand and volume-allocation mechanism will directly affect hospital supply and sales across the alliance regions.

Three-Year Procurement Cycle, With Hospital Demand Affecting Selected Companies’ Volumes

According to the draft documents, procurement agreements for the two categories will generally be signed annually during the procurement cycle, although agreements may also be signed once for the entire cycle.

The total contracted procurement volume for each year will generally be no less than 90% of the actual use of selected products in the previous year.

The annual contracted procurement volume for each selected company will generally be no lower than that company’s contracted volume in the previous year.

The agreements must specify both supply prices and supply quantities.

For medical device manufacturers, participation requires more than preparing qualification materials such as registration certificates and product instructions.

Companies must also maintain their medical insurance coding information and confirm that their products have sufficient production and supply capacity.

Products that have already been discontinued or are no longer supplied may not be submitted.

For peripheral constrained balloons, hospitals’ existing utilization will affect the underlying demand volume attributed to individual companies.

For powered pulse lavage devices, differences in structure, pricing and supporting equipment requirements between integrated power-driven and external equipment-driven products may also influence hospitals’ choices.

Companies wishing to comment on the two draft procurement documents are required to complete separate feedback forms and submit them by 18:00 on November 15.

The process will then move into subsequent stages including publication of the final procurement documents, company declarations, price quotations and determination of selected results.

The specific timetable has yet to be announced.

November 10, 2026