For any medical device company entering China, one of the first regulatory questions is simple:

Is the product Class I, Class II or Class III?

The answer affects who regulates the product, whether filing or registration is required, the regulatory pathway before commercialization, and the subsequent requirements for manufacturing and distribution.

China uses a risk-based, three-class medical device classification system administered by the National Medical Products Administration (NMPA).

The basic structure is straightforward:

Under China's current Regulations for the Supervision and Administration of Medical Devices, Class I devices are those with relatively low risk for which routine administration can ensure safety and effectiveness; Class II devices present moderate risk and require stricter controls; Class III devices present relatively high risk and require special measures to ensure safety and effectiveness.

The three-class concept looks familiar to executives who work with the U.S. FDA or European MDR.

The details, however, are Chinese.

A device classified as Class II in the United States cannot automatically be assumed to be Class II in China. European MDR classification is also not directly transferable to the NMPA system.

The Chinese classification must be determined under China's own rules and classification catalogues.

The Short Answer: What Do Class I, II and III Mean in China?

Class I: Low Risk

Class I medical devices are subject to product filing rather than product registration.

For a domestically manufactured Class I device, the filing is handled by the drug regulatory authority of the relevant city divided into districts.

For an imported Class I device, the filing is submitted to the NMPA.

Examples found within China's Class I system include certain reusable manual surgical instruments and other relatively low-risk devices. China's dedicated Catalogue of Class I Medical Devices, issued in 2021 and effective from January 1, 2022, provides the principal reference for Class I products.

Class II: Moderate Risk

Class II devices require product registration.

For a Chinese domestic Class II device, registration is reviewed and approved by the drug regulatory authority of the province, autonomous region or municipality directly under the central government.

Imported Class II devices are reviewed by the NMPA.

Medical masks provide an easily understood example. In China, medical masks, including medical surgical masks, are managed as Class II medical devices.

Many diagnostic and monitoring products also fall into Class II, although classification always depends on the specific intended use, technology and risk characteristics of the product.

Class III: High Risk

Class III devices require registration and are subject to the highest level of regulatory control within China's three-class system.

Domestic Class III devices are reviewed by the NMPA. Imported Class III devices are also reviewed by the NMPA.

Many high-risk implantable, interventional and active therapeutic devices fall into this category.

Surgical robots are a particularly relevant example. China's medical device classification catalogue identifies surgical robots and surgical navigation systems as Class III medical devices.

For companies developing advanced cardiovascular devices, surgical robotics, neurointervention or other high-risk technologies, Class III registration is therefore common.

How Does China Decide Whether a Device Is Class I, II or III?

China does not classify a medical device simply according to what the manufacturer calls it.

Under the NMPA's Rules for Classification of Medical Devices, classification is based on the degree of risk and takes into account several factors:

• intended purpose;

• structural characteristics;

• pattern of use;

• conditions and duration of use;

• whether the product contacts the human body;

• where and how it contacts the body;

• and the potential consequences if the device fails.

The rules distinguish, among other things, between active and non-active devices, invasive and non-invasive devices, implantable devices, reusable surgical instruments, standalone medical software and devices with measuring functions.

This means two devices that look similar commercially may receive different regulatory classifications if their intended uses or risk profiles are different.

Consider a simple example.

A piece of software used only to store or display information may have a very different regulatory status from software that analyzes medical images and generates information used for diagnosis.

Similarly, two catheters may fall into different classes depending on where they are used, how long they remain in the body and whether they enter the cardiovascular or central nervous system.

Intended use matters as much as physical appearance.

Several NMPA Rules Can Automatically Push a Product Into a Higher Class

China's classification rules contain a number of principles that are particularly useful for international manufacturers to understand.

Sterile Devices

A medical device supplied in a sterile state cannot be lower than Class II under the classification rules.

This is one reason apparently simple disposable devices may still be classified above Class I.

Devices With Measuring Functions

A medical device with measuring functions cannot be lower than Class II.

Devices Intended for Treatment

A device intended for the treatment of a disease cannot be lower than Class II.

Absorbable Medical Devices

Absorbable medical devices are classified as Class III under the classification rules.

Drug-Device Combination Products

Where a drug-device combination product achieves its principal effect as a medical device, China's classification rules require it to be managed as a Class III medical device.

Devices With More Than One Possible Classification

If two or more classifications could apply to the same medical device, the classification representing the highest degree of risk is used.

For a kit composed of multiple medical devices, the class is determined according to the component with the highest risk classification.

These rules are important because classification cannot always be inferred simply by finding one apparently similar device in an overseas database.

Who Actually Approves the Device?

For international companies, one of the easiest ways to understand China's system is to separate domestic devices from imported devices.

Domestic Medical Devices

Imported Medical Devices

These responsibilities are explicitly set out in China's current Provisions for Medical Device Registration and Filing.

This distinction matters.

A Chinese manufacturer registering a Class II device normally works through its provincial regulator.

A U.S., European or Japanese manufacturer importing the equivalent Class II device into China applies at the national level through the NMPA.

Filing and Registration Are Not the Same Thing

The difference between filing and registration is fundamental to China's regulatory system.

Class I: Filing

The manufacturer or filing entity submits the required product information to the appropriate regulatory authority.

Class I products are managed through the filing system rather than the premarket registration system applied to Class II and III products.

NMPA has also clarified that clinical evaluation data are not required when filing a Class I medical device.

Class II and III: Registration

Class II and Class III products must undergo regulatory review and receive a Medical Device Registration Certificate before they may be marketed under the registration pathway.

Registration dossiers include areas such as:

• product risk analysis;

• product technical requirements;

• product testing;

• clinical evaluation where applicable;

• instructions for use and labeling;

• and quality-management-system information relating to R&D and manufacturing.

These requirements are specified in the NMPA's registration and filing provisions.

Does Class III Automatically Mean a Clinical Trial Is Required?

No.

This is an important distinction for international companies.

A higher device class generally means greater regulatory scrutiny, but classification and the requirement for a clinical trial are separate questions.

Under current NMPA rules, clinical evaluation may be conducted using different forms of evidence depending on product characteristics, clinical risk and available clinical data.

Evidence can include analysis of clinical literature and clinical data from predicate devices. A clinical trial is required when the available evidence is insufficient to demonstrate safety and effectiveness. NMPA also maintains circumstances under which clinical evaluation may be exempted.

Certain particularly high-risk Class III medical device clinical trials require specific NMPA approval before the trial begins, but this requirement applies to a defined subset of Class III devices rather than every Class III product.

For a foreign manufacturer, therefore, these are separate questions:

What class is my device?

and

What clinical evidence will NMPA require for this particular registration?

They should not be treated as the same regulatory decision.

China Uses a Classification Catalogue — But the Catalogue Changes

The classification rules provide the regulatory logic.

The Medical Device Classification Catalogue provides much of the practical product-level framework.

China's classification system uses product categories and classification codes. The 2017 classification catalogue is organized through subcatalogues numbered 01–22, with product categories and subcategories beneath them.

China subsequently issued a dedicated Catalogue of Class I Medical Devices in 2021, effective from January 1, 2022.

The important point for a company entering China in 2026 is that these catalogues should not be treated as static historical documents.

NMPA continuously performs classification determinations and adjusts the catalogue as technologies and risk assessments evolve.

In 2025 alone, the agency published four batches covering 992 typical product classification determinations.

On June 1, 2026, NMPA issued a new Work Procedure for Dynamic Adjustment of the Medical Device Classification Catalogue and separate requirements governing products affected by classification changes.

This matters particularly in emerging areas such as:

• artificial intelligence;

• medical software;

• surgical robotics;

• rehabilitation robotics;

• brain-computer interfaces;

• new biomaterials;

• and novel combination products.

For example, in June 2026 NMPA issued a dedicated classification guidance document for brain-computer-interface medical devices, illustrating how new technology categories are being incorporated into the regulatory classification system.

A Product's Classification Can Change

Companies should not assume that a classification assigned years ago will necessarily remain unchanged forever.

NMPA can adjust classifications when:

• new safety information emerges;

• the understanding of product risk changes;

• technology evolves;

• new categories are introduced;

• or existing classification catalogue entries require modification.

China explicitly maintains a dynamic classification-adjustment mechanism for this purpose.

This can have meaningful commercial consequences.

If a product is moved from a lower class to a higher class, manufacturers may need to transition from filing to registration or meet the requirements associated with the new classification.

Conversely, when a product is moved to a lower class, the applicable registration or filing pathway can also change.

NMPA issued specific transition rules in June 2026 covering products whose management category changes, products newly brought under medical-device regulation and products that cease to be managed as medical devices.

For regulatory teams, classification monitoring should therefore continue after product launch.

What If Your Product Is New and You Cannot Find It in the Catalogue?

This situation is increasingly common.

An innovative device may have:

• a new mechanism;

• a new intended use;

• a combination of existing technologies;

• software or AI functions not covered clearly by older categories;

• or no obvious equivalent in the existing catalogue.

Finding an apparently similar registered product can provide useful context, but it does not by itself establish the legal classification of a new product.

China maintains a medical device classification determination mechanism for products whose regulatory status or classification is unclear.

NMPA's technical institutions are responsible for classification and definition work, and the agency regularly publishes classification-determination results to provide additional reference for industry.

For an innovative product, classification should therefore be addressed early in the China regulatory strategy.

Discovering late in development that a product is Class III rather than Class II can materially change the evidence, registration and commercialization plan.

What About IVD Products?

In vitro diagnostic reagents belong within China's medical-device regulatory system, but they have their own classification and registration provisions.

Like other medical devices, IVD reagents are divided into Class I, Class II and Class III.

Class I IVD reagents are filed, while Class II and Class III IVD reagents require registration.

For domestic IVDs:

• Class I filing is handled at city level;

• Class II registration is handled at provincial level;

• Class III registration is handled by NMPA.

For imported IVDs, Class I filing and Class II/III registration are handled by NMPA.

Companies developing laboratory diagnostics should therefore use the IVD-specific regulatory framework rather than assuming that the general classification rules for medical devices answer every question.

Classification Also Affects Manufacturing and Distribution

Product classification continues to matter after market authorization.

China also applies risk-based controls to medical-device manufacturing and distribution.

Manufacturing

For domestic manufacturing:

Class II and III manufacturers must obtain a Medical Device Manufacturing License from the relevant provincial drug regulatory authority. Class I manufacturing is subject to filing with the regulator at city level.

Distribution

As a general rule:

NMPA regulations provide that Class III distribution requires licensing, Class II distribution requires filing, and Class I distribution can generally be conducted without either.

Certain Class II products may be exempt from distribution filing under an NMPA catalogue.

The practical implication is important:

classification affects more than the initial product approval.

It can influence the regulatory structure of the entire Chinese commercial chain.

Three Examples

The following examples illustrate the basic logic, although the actual class of any particular product must always be confirmed against its specific characteristics and intended use.

The first category is represented in China's Class I device catalogue; NMPA has confirmed that medical masks are managed as Class II devices, while the classification catalogue identifies surgical robots as Class III.

The jump from a manual instrument to a medical mask and then to a surgical robot also helps illustrate an important principle:

China's three classes are fundamentally about regulatory risk rather than price, technological sophistication or hospital purchasing value.

An expensive piece of equipment is not automatically Class III.

A small disposable implantable or interventional product can carry much greater regulatory risk than a large capital device.

Is China's Class II the Same as FDA Class II?

No.

This is one of the most common shortcuts foreign companies should avoid.

China, the United States and the European Union all use risk-based concepts, but their:

• classification rules;

• product categories;

• regulatory precedents;

• submission systems;

• evidence requirements;

• and competent authorities

are different.

A company's existing FDA or CE regulatory history can be highly relevant to its China strategy, but the overseas classification itself does not determine the NMPA classification.

For China, companies should conduct a separate classification analysis under NMPA rules.

A Practical Classification Workflow for Companies Entering China

For a foreign MedTech company, the process can be organized into six steps.

Step 1: Confirm That the Product Is Regulated as a Medical Device

Before determining Class I, II or III, determine whether the product falls within China's definition of a medical device.

This becomes especially important for software, wellness technologies, combination products and emerging digital-health products.

Step 2: Define the Intended Use Precisely

Classification analysis should use the actual:

• intended purpose;

• target patient;

• clinical setting;

• mode of action;

• body-contact characteristics;

• duration of use;

• and risk profile.

A vague commercial product description is insufficient.

Step 3: Search the Current NMPA Classification Catalogues

Identify the relevant product category, subcategory and classification code.

Do not rely only on an old PDF or an internal regulatory database.

China's classification catalogue is subject to continuing adjustment.

Step 4: Review Recent Classification Determinations and Adjustments

For emerging technologies, recent classification decisions may be more informative than the original catalogue entry.

NMPA published 992 typical classification determination results in 2025 alone, demonstrating the scale of this ongoing work.

Step 5: Seek Classification Determination When Necessary

If the product does not fit clearly within existing categories, companies should use the appropriate Chinese classification-determination process rather than selecting a class based solely on an overseas equivalent.

Step 6: Build the Registration Strategy Around the Confirmed Classification

Once the class is established, determine:

• filing versus registration;

• responsible regulatory authority;

• product testing strategy;

• clinical evaluation pathway;

• quality-management-system requirements;

• and manufacturing and distribution requirements.

Classification is therefore one of the first building blocks of the China market-entry plan.

What Global MedTech Companies Should Remember

For executives rather than regulatory specialists, five points cover most of what matters.

One additional point deserves emphasis:

China's classification system is dynamic.

For established categories, classification can often be determined relatively easily from the catalogue.

For surgical robotics, AI medical devices, brain-computer interfaces and other rapidly evolving technologies, companies should also follow recent NMPA classification guidance and classification-adjustment announcements.

The Bottom Line

China's medical-device classification system starts with a simple structure:

Class I — low riskClass II — moderate riskClass III — high risk

But the number itself is only the beginning.

For companies entering China, classification determines the regulatory authority and whether the product follows a filing or registration route. It also interacts with manufacturing, distribution, clinical evidence and post-market regulatory responsibilities.

The practical sequence is:

define the product → determine the NMPA classification → identify the regulatory pathway → prepare the required evidence → obtain filing or registration → commercialize under the corresponding regulatory controls.

Getting the classification right early can prevent major changes later in the China development and market-entry process.

August 18, 2026