On September 16, 2026, China’s National Healthcare Security Administration (NHSA) formally released the Work Plan for Formulating the National Basic Medical Insurance Medical Service Item Catalog (First Batch).

The move marks the first formal launch of a national-level medical service reimbursement catalog, moving China’s medical service payment system from largely province-based management toward a more unified national framework.

The first batch will cover 13 categories, including cardiovascular, respiratory, ophthalmology, gynecology, radiotherapy, anesthesia, nursing, clinical scale assessment, dental implantation, assisted reproduction, obstetrics, radiological examination and rehabilitation.

For the medical device industry, the policy matters beyond reimbursement itself.

Together with the nationwide standardization of medical service pricing items and the planned unification of medical consumables reimbursement management, medical device commercialization is gradually being placed behind three national-level payment gateways:

a unified charging framework, a unified medical insurance payment framework, and a more unified consumables reimbursement framework.

Medical Devices Entering Hospitals Now Face Three Payment Gateways

For a medical device to move from regulatory approval to routine clinical use, approval alone is not enough.

Hospitals also need to answer several practical questions:

• Is there a medical service item under which the procedure can be charged?

• Is that service covered by basic medical insurance?

• If consumables are required, can those consumables be reimbursed?

• Can the same model be applied consistently across different provinces?

Historically, these questions have often had different answers in different regions.

China’s medical service pricing system was long managed locally. Provinces could differ substantially in project names, definitions, pricing rules and reimbursement coverage.

NHSA has been working to reduce this fragmentation.

By September 2026, the agency had completed 40 batches of national medical service pricing guidelines, consolidating local charging items into 2,624 main items, 742 surcharge items and 174 extension items.

The newly released national medical insurance service catalog represents the next step.

First gateway: a nationally standardized charging item

The first question is whether a hospital has a legitimate pricing item under which it can charge for the service associated with a medical device.

The 40 batches of pricing guidelines are intended to standardize the naming, service content and charging logic of medical services nationwide.

The core principle is that pricing items should reflect the clinical service output, rather than being directly tied to a particular device, consumable or technical pathway.

This changes the commercialization logic for medical device companies.

A new piece of equipment does not automatically justify a new medical service pricing item simply because it is more advanced or more expensive.

The relevant question becomes whether it produces a distinct, complete and verifiable medical service outcome.

For innovative devices, NHSA has also introduced a pre-establishment mechanism for medical service pricing items. Qualified new technologies and products can begin the pricing-item application process before full market approval, potentially reducing the delay between regulatory clearance and clinical charging.

Second gateway: a nationally unified medical insurance payment catalog

Having a charging item does not necessarily mean the service will be reimbursed by basic medical insurance.

Until now, provinces have largely determined their own medical service reimbursement scope according to local clinical needs, payment capacity and fund conditions.

That has created considerable regional differences.

The new national catalog is intended to gradually establish a more unified medical service reimbursement framework.

According to NHSA, the catalog will initially be used for cross-provincial medical treatment settlement, before being progressively aligned with provincial medical service reimbursement scopes.

This is important for medical device companies operating nationally.

If implemented as planned, companies will face a more standardized reimbursement environment instead of needing to interpret a completely different payment structure in every province.

Third gateway: medical consumables reimbursement

For many medical devices, the procedure itself is only one part of the payment equation.

Implants, catheters, surgical tools, disposable accessories and other consumables may also represent a significant share of the total cost.

China is also moving toward greater standardization of medical consumables management, including unified classification, coding and reimbursement naming.

Together, these reforms point toward a three-layer structure:

medical service pricing determines whether a hospital can charge;

medical insurance coverage determines whether the service can be reimbursed;

consumables reimbursement determines how device-related disposable costs are handled.

For device manufacturers, all three can affect whether a product can achieve routine clinical use after approval.

Why the First 13 Categories Matter to the Medical Device Industry

The composition of the first batch is particularly relevant to medical technology companies.

The 13 categories include several areas with intensive use of medical devices, such as:

• cardiovascular care

• respiratory care

• ophthalmology

• gynecology

• radiotherapy

• anesthesia

• radiological examination

• rehabilitation

This means the first phase of national reimbursement evaluation will directly touch multiple major device markets.

The final list differs from the earlier draft released for public consultation.

The consultation draft had proposed 11 categories and included several traditional Chinese medicine categories.

The formal September plan instead expanded the first batch to 13 categories, adding major clinical systems such as cardiovascular, respiratory, ophthalmology, gynecology, radiotherapy, anesthesia and nursing, while the earlier TCM categories were not included in the first formal batch.

The change makes the first formal catalog more directly relevant to medical devices and hospital-based technologies.

How Will Medical Services Be Evaluated for Inclusion?

According to the Work Plan, a medical service item must meet several basic conditions to enter the national reimbursement catalog.

It should:

• already be included in the current national medical service pricing guidelines;

• be clinically necessary, safe and effective;

• have an appropriate price;

• have a controllable impact on medical insurance fund expenditure.

Items may be excluded if they fall outside the basic medical insurance scope, have insufficient clinical use, uncertain effectiveness, major safety risks or other characteristics inconsistent with basic insurance coverage.

The evaluation process will include both management and clinical experts.

Items will be assessed across dimensions including:

• health benefit

• clinical need

• equity

• cost-effectiveness

• impact on the medical insurance fund

This makes reimbursement increasingly relevant to device companies’ evidence strategies.

Registration evidence may answer whether a product is safe and effective.

Medical insurance evaluation may ask another set of questions: Is the associated medical service necessary? How much health benefit does it provide? Is it cost-effective? Can the insurance fund afford broad coverage?

From Provincial Differences Toward a National Framework

The national catalog does not mean that every province will immediately adopt identical reimbursement policies.

NHSA has made clear that the transition will be gradual.

The catalog will first support cross-provincial settlement, while local reimbursement scopes will subsequently be aligned with the national framework over time.

The direction, however, is clear.

China has already moved toward national standardization in medical service pricing, and the new catalog extends that process to medical insurance coverage.

As of September 18, provinces had implemented an average of 37 batches of national pricing guidelines, while 16 provincial-level regions had completed implementation of 39 batches.

The system is therefore moving from a situation in which medical service charging and reimbursement can vary substantially by region toward a framework with increasingly common national rules.

What Does This Mean for Medical Device Companies?

For medical device companies, market access in China is becoming a longer but more clearly defined chain.

Regulatory approval remains the first requirement, but it may increasingly need to be followed by:

regulatory approval → medical service pricing → medical insurance coverage → consumables reimbursement → hospital adoption.

This has several implications.

First, companies may need to consider reimbursement much earlier in product development.

A device may be technically innovative but still face commercialization difficulties if the associated service does not have an appropriate pricing or reimbursement pathway.

Second, clinical evidence may need to address more than safety and efficacy.

Evidence on health benefit, cost-effectiveness, resource utilization and real-world value could become more important as reimbursement evaluation becomes more standardized.

Third, national standardization could reduce some of the province-by-province market-access burden.

A clearer national framework may make commercialization more predictable, although local implementation and fund capacity will continue to matter.

A More Unified Payment Infrastructure Is Taking Shape

The latest Work Plan should therefore be viewed together with several other reforms.

China has completed the national standardization of medical service pricing items, is establishing a national medical service insurance catalog, and is continuing to standardize medical consumables classification and reimbursement management.

For the medical device industry, these reforms are gradually creating a common payment infrastructure.

The key question for companies will no longer be simply whether a device can obtain regulatory approval or enter a hospital.

Increasingly, they will also need to answer whether the associated medical service has a nationally recognized charging pathway, whether it meets medical insurance coverage criteria, and how the related consumables are reimbursed.

The commercial pathway for medical devices in China is therefore becoming more standardized — and more closely tied to demonstrable clinical and economic value.

September 18, 2026