Recently, many places have issued notices with requirements regarding the listing conditions and prices of medical consumables. Hunan Province has solicited opinions requiring compliance with listing conditions from other provinces or record-filing for procurement within the province. Once implemented, compared with the current policies in Hunan, the entry requirements for enterprises will be even higher.
Shandong's cancellation of the reserve pool will also affect the access and sales qualifications of many enterprises in Shandong. The benefits of new products being prioritized and quickly listed online in provinces such as Hunan and Shandong will also disappear. The national access speed for newly licensed products will slow down.
Jiangxi Province will carry out online governance of non-selected products with national volume-driven volume in accordance with the requirements of the State Procurement Office. This will be a trend in the future. For non-selected consumables in the national, alliance or provincial volume-based directories, it will have a significant impact, especially in economically developed areas with a large number of private hospitals. For manufacturers, unless your registration certificate "bench" depth is deep enough, you will definitely participate in volume-based or be added to the volume-based directory.
Recently, the Medical Insurance Bureau of Hunan Province issued the "Notice on Regulating the Sunshine Online Procurement of Medical Consumables (Draft for Comment)", the core content of which is as follows:
The scope of listing is clear: medical consumables with medical insurance codes that have been approved by the drug regulatory department and obtained the "Medical Device Registration Certificate" or the "Medical Device Filing Certificate", as well as in vitro diagnostic reagent products managed as medical devices.
Directory classification and access rules:
The requirements for the linked listing directory: For consumables not listed in Hunan Province, they must be listed on three other provincial procurement platforms and apply for listing at a price not higher than the provincial minimum reference price. For consumables listed on the provincial platform, there must be a filing and procurement record in the procurement management system of five secondary or higher public medical institutions within Hunan Province.
Special circumstances: For ** products and innovative medical devices, the threshold for listing on the Internet has been further lowered, encouraging domestic and foreign medical device manufacturing enterprises to apply for listing in Hunan.
Regulations on classified procurement: Gradually improve the centralized procurement norms for medical consumables, formulate the listing directory of medical consumables, clarify the listing conditions for classified procurement of medical consumables, determine the formation rules of listing prices, establish the behavioral norms for classified procurement transactions, and establish a dynamic adjustment mechanism for the listing directory and listing prices of medical consumables.
Early warning intervention mechanism for listed prices: Set a purchase price early warning threshold, which is 50% of the listed price. When the transaction price of consumables products below the warning threshold is generated, if the proportion of the purchase quantity below the warning threshold to the total purchase quantity of the product within one month is higher than 10%, it will be listed as a key monitored category, and the enterprise will be urged to lower the listing price of the product to within the average of the actual effective transaction price or 80% of the listing price (the lower of the two). If the enterprise refuses to adjust and the appeal is unsuccessful, the listing will be suspended.
Strengthening supporting measures: Clearly define the corresponding responsibilities and restrictive incentive measures of the participants in the centralized procurement of medical consumables. Strengthen the primary responsibility of public medical institutions for the procurement and use of medical consumables, adhere to online procurement, and completely eliminate off-network procurement. The medical security department should strengthen the supervision of online procurement by medical institutions and incorporate the requirements for online procurement into the management of service agreements for medical insurance designated medical institutions. The health and wellness department has incorporated the online procurement of medical consumables by public medical institutions into the comprehensive supervision of medical institutions and the performance assessment of the responsible persons of medical institutions. Drug regulatory authorities have strengthened supervision over the quality, production and circulation of medical consumables, and promptly investigated and dealt with illegal acts related to the quality of consumables and their production and operation. Implement the main responsibility for the production and operation of medical consumables, enforce the regulations on the credit evaluation system for medical prices and procurement, and strengthen the credit rating of untrustworthiness in the field of centralized procurement of medical consumables.
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Notice of Jiangxi Province on Further Strengthening the Online Price Management of Non-Selected Products in the National Organization of Intraocular Lenses and Sports Medicine Centralized Procurement
All relevant units:
In accordance with the relevant requirements of the "Notice on Pushing the High Line of Listing Prices for Non-Selected Products in the Fourth Batch of National Organization and Joint Grafting Volume-based Procurement in Tianjin" issued by the National Organization Office for Joint Procurement of High-Value Medical Consumables, in order to further strengthen the management of listing prices for non-selected products in the national procurement of intraocular lenses and sports medicine, the following matters are hereby notified.
一、Product Categories and High Price Lines
The listing price of non-selected products in centralized procurement must not exceed the high price line. For specific product categories and high price lines, please refer to Attachment 1.
二、Relevant Requirements
（一）If the current listing price does not exceed the upper price line, the current listing status shall be maintained. If the current listed online price is higher than the high price line, it needs to be adjusted to no higher than the high price line. Those who do not agree to the price adjustment will have their online procurement qualification suspended (for details, see Attachment 2).
（二）If the enterprise agrees to adjust the listed price to no higher than the high price line, please log in to the Jiangxi Province Procurement and Bidding Management Subsystem, enter the "Online Service Hall - Consumables Service Hall - Changes in Listed Prices of Consumables" column, and in the "Pending Submission - List of Listed Products for Price Adjustment of Consumables" interface, the system has added the information of the products whose prices are proposed to be adjusted. The reason for the application is marked as "Price adjustment of non-selected products in the national organization's centralized procurement of intraocular lenses and sports medicine". Enterprises should check the product details, declare the new online listing price, and submit the application materials with the official seal of the unit before 17:00 on May 19th.
（二）For products that are urgently needed in clinical practice and cannot be replaced by the existing listed products, if medical institutions have genuine procurement demands, they can implement filing procurement through the provincial procurement subsystem.
（三）For non-selected products that have not yet been listed, when they apply for listing in the future, their listing prices should comply with the requirements of this notice.
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Notice of Shandong Province on Stopping the Acceptance of Applications for Alternative Consumables List Products and Adjusting the List
All relevant enterprises:
In order to further strengthen the price management of medical consumables (including in vitro diagnostic reagents) listed on the Shandong Province Drug and Medical Consumables Procurement Management System, standardize the price declaration behavior of enterprises, in accordance with the arrangements and deployments of the Shandong Provincial Medical Security Bureau, the declaration of products in the alternative consumables list will be stopped from now on, and the alternative consumables list will be cleared at an appropriate time. The relevant matters are notified as follows:
一、Processing of Declared Products
Applications for the listing of the alternative consumables list submitted after April 1, 2025 will be returned.
二、Price Linkage (Alternative to Sunlight)
Relevant enterprises must apply through price linkage (from reserve to Sunshine) to transfer the listed products in the reserve consumables directory to the Sunshine listed directory by the end of June, and form the listed prices that meet the requirements.
Operation path: Procurement Management Subsystem - Consumables Procurement Management - Online Listing Application Management - Price Linkage (Alternative to Sunshine) Application - Price Linkage Application - New - Select the information of consumables for alternative to Sunshine, submit the screenshot of the lowest provincial online listing price nationwide, fill in the minimum package price (not higher than the self-quoted price and the lowest provincial online listing price nationwide) - Submit and wait for acceptance. After verification and public announcement without any objections, it will be included in the Sunshine online listing directory.
三、 Alternative Consumables List: Other Products
For consumables products in the alternative consumables list that do not comply with the price linkage (alternative to Sunshine) listing rules or those that comply with the rules but have not applied for transfer to the Sunshine listing list, the platform will choose an appropriate time to clear and handle them.
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