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Is my product considered a medical device in China?

Is my product considered a medical device in China?

Elaine Tan
February 12, 2025

Your company has decided to develop a medical device for the mid-range market to cover the medical demand. Great! However, the People’s Republic of China falls within one of the priority countries for launching. What to do now?

China is regarded as one of the hardest countries to obtain product approval from, so there is no doubt that several questions may pop into your mind. First, let’s ask the dumb, yet fundamental question. “Is my product a medical device in China?” and “How does the product classification work there?”. This post will cover the definition of the medical device and the comparison between China and other major reference countries.

If your company has marketed the product in the EU or US as a medical device, there is a high chance that the product is also a medical device in China unless you argue otherwise. Of course, we aren’t perfect and we get stuck sometimes! An alternative measure will also be briefly touched upon, so don’t sweat yet!

To answer this question, some understanding of your product is essential. Gear up and below are some points that you need to be clear to start with:

Form of products (e.g. physical device or IVD kit, materials or software)
Intended purpose (the effect of a device, e.g. wound support, cancer diagnosis or screening, devices to support surgical procedures, etc.)
Indication for use (the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified, or controlled by the medical device, including its patient population)
Mode of action (e.g. pharmacological, immunological, metabolic, physical, or other. It must be based on state-of-the-art scientific data.)
The presence of contact with the human body (e.g. whether your product has direct or indirect contact with the skin, tissue, organ, etc)

Definition of the medical device in China

In accordance to Chapter 8 of Order No. 739 of 2021 “Medical Device Supervision and Administration Regulations”, a medical device is defined as follows:

Medical devices refer to any instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or associated articles that are used directly or indirectly on the human body, including the needed software for its application.

Its principle action is primarily derived through physical means, not through pharmacological, immunological or metabolic means; these means can be involved, but they only serve as an auxiliary role to achieve the following intended purposes:

(a) diagnosis, prevention, monitoring, treatment or alleviation of diseases;
(b) diagnosis, monitoring, treatment, alleviation or functional compensation of injuries;
(c) inspection, replacement, modification or support of anatomy or physiological processes;
(d) life support or maintenance;
(e) pregnancy control;
(f) provision of information for medical or diagnostic purposes through examining the samples from the human body.

The definition in comparison with the EU and US

The definition is almost identical between China and the EU. One point that is worth noting is that disinfection and sterilization equipment for medical devices that are not in contact with the human body and are used for disinfection and sterilization of medical devices are considered medical devices even though it is not explicitly stated in the definition of the medical device for China, excluding special disinfection devices in the form of a combination of “non-active medical devices or components + chemical disinfectants”. This is identical to the definition of the medical device according to Regulation (EU) 2017/745 or EU MDR. The differences between China and other main jurisdictions (e.g. EU and US) are highlighted in red and comparisons of the differences are summarized in the table below:

Aspect	China	EU MDR	US FDA
Definition of medical device	Medical devices refer to any instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or associated articles that are used directly or indirectly on the human body, including the needed software for its application. Its effect is primarily derived from physical means, not through pharmacological, immunological or metabolic means; these means can be involved, but they only serve as an auxiliary role to achieve the following intended purposes: (a) diagnosis, prevention, monitoring, treatment or alleviation of diseases; (b) diagnosis, monitoring, treatment, alleviation or functional compensation of injuries; c) inspection, replacement, modification or support of anatomy or physiological processes; (d) life support or maintenance; (e) pregnancy control (f) provision of information for medical or diagnostic purposes through examining the samples from the human body.	‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: • devices for the control or support of conception; • products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.	An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: (A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o). Examples of excluded software: • Administrative support of a health care facility; • Maintaining or encouraging a healthy lifestyle unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; • Serve as electronic patient records; or • Transferring, storing, converting formats, or displaying test or other device data, results or findings but not intended to interpret or analyze them.
Scope	Includes medical devices for human use only. Clear delineation for both physical and software devices, with separate regulations and rules for in vitro diagnostic (IVD) devices.	Focuses exclusively on human use like China. Covers a broader spectrum of devices, including software as well as some aesthetic products with no medical purpose (e.g., coloured contact lenses).	Medical devices and software for human, as well as animal use (e.g. veterinary devices) for medical purposes are within the scope.
Primary mode of action	Primarily physical means rather than pharmacological, immunological, or metabolic means, but may be assisted by such means. Highly comparable to EU and USA.	Does not achieve its principal intended action by pharmacological, immunological, or metabolic means but may be assisted by such means.	Does not achieve its primary intended purposes through chemical action within or on the body and is not dependent on being metabolized.
Standards	The standard reference is not mentioned in the definition, but the devices shall comply with the list of applicable local standards published by NMPA.	Not explicitly mentioned in the definition, but the devices shall use harmonized standards outlined by the European Commission or applicable standards to define GSPRs that apply to the product.	Explicitly references recognized pharmacopoeia standards (National Formulary or United States Pharmacopoeia). This means that some medical devices may have chemical or material components for which established pharmacopoeia standards exist. Devices containing or used with such substances are expected to meet these standards to ensure safety and effectiveness.

What if you can’t evaluate whether it is a medical device?

If your product doesn’t fall into any of the product categories or you are unsure whether it is a medical device or risk class, take a deep breath and don’t panic. You can submit a request for an NMPA evaluation to define the product category and exact classification of the medical device. Following are a few examples of NMPA responses on what are or are not managed as medical devices:

Artificial Intelligence Medical Software
Suppose the processing attribute of the software product is medical device data, and the core function is the processing, measurement, model calculation, analysis, etc. of the medical device data, and used for medical purposes. In that case, it is managed as a medical device.
Suppose the processing attribute of the software product is non-medical device data (e.g. information such as patients' complaints, conclusions of test and inspection reports), or its core function is not processing, measuring, modeling, analyzing medical device data, or not used for medical purposes. In that case, it is not managed as a medical device.

Disposable medical gas cylinders
Made of polymer materials, they are used with disposable infusion sets after being filled with oxygen at oxygen plants. As medical oxygen is managed as a drug, disposable medical gas cylinders should be considered as drug packaging materials and are not managed as medical devices.

Surgical instrument detergent
It is used for decontaminating and washing surgical instruments, has no disinfection or sterilization function, and is not managed as a medical device.

Thermal blanket
It is used to maintain the patient's body temperature and is not managed as a medical device.

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Disclaimer:

This content is created solely in my personal interest and does not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. The information provided is for general informational purposes only and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter is non-commercial and does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.