Harmonization is a popular topic in recent years. South Africa just joined the Medical Device Single Audit Program (MDSAP) as an affiliate member.

There have been attempts to urge the EU to become a member of the MDSAP. MedTech Europe and COCIR have published a joint reflection paper calling on the EU to join the Medical Device Single Audit Program (MDSAP).

Can you visualize the future between the EU and MDSAP? How open is China towards harmonization?

China’s National Medical Products Administration (NMPA) references international regulatory frameworks when drafting new policies and regulations.

EU Medical Device Regulation (MDR) and the International Medical Device Regulators Forum (IMDRF) are often used as blueprints.

NMPA also adopts the China standards based on ISO and IEC standards to define technical and safety benchmarks.

Last month, NMPA released a draft revision of its medical device classification rules. If you're still referencing the 2015 version, it's time to put those old chopsticks down and grab a fresh pair.

Let’s see how the new version of the classification rules will evolve.

Why did NMPA decide to revise?

China reworked the device classification rules (Order No. 15) to create a risk-based system and to align with international norms back in 2015.

How far did it go? No change for a decade. So the classification rule has been outdated.

Industry leaders have asked for clarity on where it stands in the global arena.

Fast-forward to now, the landscape has shifted. A wave of digital health, implantables, and bio-derived materials. It is a new era of technological and innovative blooms.

A continuous effort of NMPA to work towards the global alignment with IMDRF and EU MDR. Thus, the draft of the Classification Rules is now out for public comment.

The new draft mainly focuses on the following changes:

• Change in the definition of the regulatory terms

• Change of the scope of the product category

• Revision/ restriction of classification principles

If you have doubts about the fundamentals of the classification, my previous post summarized the absolute basics.

Definition Change of the Regulatory Terms

The NMPA proposal includes modifications, complementations, and additions to regulatory terminologies.

These changes are signs that the NMPA is making efforts to align with international regulators. So, what are some important changes?

Invasive devices

Previously, the definition only covered the medical devices that penetrate the human body, in whole or in part, through the surface of the body by means of surgery.

It is proposed to remove “by means of surgery”. The usage of invasive devices is not limited to the surgical procedure.

Other forms of invasive instruments, such as puncture needles, blood collection needles and etc., are examples. These instruments are also used in a non-surgical environment, such as when you get a shot in the clinic.

The definition becomes closer to the EU MDR.

Medical devices in contact with the human body

The former definition was rather broad. It was defined as “contact with human body devices”. It may give a misleading impression that the device physically touches the patient.

The proposed change will be “direct or indirect contact with the human body or can enter the body of the medical device”.

This includes the contact established through the indirect contact with the human body of medical devices via energy.

Another example is the indirect contact with the human body through the liquid or gas tube sets.

However, this excludes the distal collection device that is used to collect human waste or body fluids.

Let’s take the waste liquid collector from the negative pressure drainage device as an example. The liquid flows from the patient (higher pressure) to the collector (lower pressure).

The direction of flow is the key. It flows unidirectionally away from the patient. In this sense, the device does not come into contact with the human body.

The NMPA used the Chinese standard GB/T 16886.1, which is equivalent to ISO 10993-1, as the baseline reference.

The NMPA also defined new terms to provide clarity on the connection between the regulatory definition and the standards. The new terms are as follows:

Surface wound

Wounds on the surface of the skin or orifice (mouth), including those formed after tooth extraction. But it excludes the injuries/wounds that form on the surface of the eyeball.

In principle, any condition that does not meet the criteria for surface wounds is considered an internal wound.

This term is brand-new. It does not exist in the EU MDR.

Absorption

Action of a non-endogenous (foreign) material or substance, or its decomposition products, passing through or being assimilated by cells and/or tissue.

The term and definition come from ISO 10993-6: 2016. This term is integrated into YY/T 1775.1-2021 Biological Evaluation of Absorbable Medical Devices Part 1: Guidelines for absorbable implants.

Medical device accessories

An adjunct used in conjunction with a medical device to achieve the intended purpose of the medical device, or fulfill specific requirements, or facilitate use, or improve performance, or activate certain functions to integrate certain functions of other devices.

The description does not reflect the definition in the EU MDR.

However, Chapter 1 Article 2 of EU MDR and GB 9706.1-2020 (aka modified version of IEC 60601-1:2012) were their references.

The Renaming of the Product Category

This section is applicable if you are manufacturers of surgical instruments for use in the reproductive and contraceptive procedures.

This will guide you to classify your products correctly. So, what has changed?

Assisted reproductive & contraceptive devices 

Contraceptive and reproductive planning equipment was the old category. It will be renamed to assisted reproductive & contraceptive devices. This is to align with the terms used in the Catalogue of Medical Devices.

NMPA also provided clarity on the product category of reusable instruments that assist reproductive and contraceptive devices. This is critical.

The assisted reproductive and contraceptive devices may include certain reusable surgical instruments to insert or remove IUDs, for vasectomical or hysterectomical procedures.

How should I classify these reusable instruments? This is a dilemma.

Such products would be classified as Class II medical devices if they are considered as assisted reproductive and contraceptive devices.

But this is wrong. These reusable surgical devices are not classified in this product category!

The reason is simple. These products belong to the category of reusable surgical devices and are classified as Class I medical devices.

The intended use of reusable surgical devices is only to assist the operations, not directly making reproduction or contraception possible. Know the differences.

NMPA added the phrase “excluding reusable surgical instruments” to provide clarity and reduce the error of misclassifying these products into the category of assisted reproductive and contraceptive devices.

Why does this matter?

For the change and specification of the product category, it potentially affects the risk classification and regulatory strategy.

A wrong classification not only costs you much time and money to launch your products, but it also increases the risks of introducing unnecessary problems that don’t exist in the first place.

That's a no-go, and we need to avoid it.

Change of Classification Principles

NMPA proposed some changes to reduce the area of grey zones and introduce more restrictions on the classification rules.  

Some key changes to Article 6 of the classification rules include:

Class I procedure kits

No non-medical product is allowed in the procedure kits consisting of Class I medical devices.

Medical device accessories

“Medical devices that can be considered as accessories” to “Medical device accessories that can be managed as medical devices independently“.

Absorbable devices

A medical device absorbed by the human body is classified as a Class III medical device. Now, an exception applies to the medical dressing.

Medical dressing is a Class III only if it has the intended use for:

➡️have anti-adhesion properties for tissues or organs
➡️internal wounds
➡️chronic wounds
➡️use as an isolation dressing, bio-dressing, non-liquid (non-gel) dressing, or animal-derived collagen dressing.

Orally administered medical devices

Devices composed of one or more substances that enter the stomach or lower digestive tract via oral administration to achieve their intended purpose and are not subsequently removed. This shall be managed as Class III medical devices if it stays inside.

This excludes gastrointestinal contrast agents and gastrointestinal ultrasound contrast agents.

Medical devices provided in a sterile form or medical devices claimed to be provided in a non-sterile form, sterilised by ethylene oxide or radiation, shall be classified as no lower than Class II.

Sterile medical devices

This refers to medical devices provided in a sterile condition. Or medical devices to be supplied in non-sterile but sterilized by ethylene oxide or radiation. 

NMPA included the sterilisation methods and medical devices that undergo post-supply sterilization. Both forms of sterile products have the same risk profile. So, it shall be classified not lower than Class II.

You can try to apply as Class I, if you use different sterilisation methods and the products fulfill the requirements of Class I.

What Should You Do?

The refinement of regulatory terminologies and the upgrade of the classification principles can shift the risk classification.

The NMPA’s potential update introduces clearer principles to regulate and strengthen the safety and performance of medical devices. It will reduce grey zones and provide more clarity on the edge.

If the new draft affects your product category, I’d suggest you do the following:

• Review your intended use and accessory list

• Re-evaluate your classification

• Update your clinical and technical files, especially definition change affects your risk profile

Soon after the release of new classification rules, the update of the catalogue list will follow.

Get in touch if you’re preparing for registration and launching a new product within a grey zone in China.

It is better to act and plan sooner rather than later.

Any questions about NMPA registration? You’re welcome to send an email to [email protected] or reach me via LinkedIn.

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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 informational purposes and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter 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.