Every RA hopes for global harmonization.

South Africa has now joined the Medical Device Single Audit Program (MDSAP) as an affiliate member.

In Europe, industry voices are getting louder too. MedTech Europe and COCIR recently published a joint reflection paper urging the EU to take part in MDSAP.

Will the EU join MDSAP in the future? And how open is China when it comes to harmonization?

China’s NMPA often looks up to international frameworks when drafting new policies.

Both the EU Medical Device Regulation (MDR) and the International Medical Device Regulators Forum (IMDRF) serve as key reference points.

On the technical side, NMPA uses ISO and IEC standards as the baseline when shaping China’s own safety and performance benchmarks.

Last month, NMPA released a new draft of its medical device classification rules.

Let’s take a closer look at what’s new.

🍜 Why did NMPA decide to revise?

China re-worked the device classification rules (Order No. 15) to create a risk-based system and to better align with international norms.

But for the past ten years, nothing changed. Meanwhile, the industry has moved further.

Manufacturers and trade groups have been calling for clarity on where China fits in the global picture.

Fast-forward to today, the market has shifted. Digital health, implantables, and bio-derived materials are reshaping the landscape.

This is part of the ongoing effort to bring China closer to IMDRF and EU MDR. The draft is currently open for public comment.

In the draft, the main updates focus on:

• Updated definition of the regulatory terms

• Expanded scope of the product categories

• Revision/ restriction on classification principles

If you’re unsure about the basics of China’s classification system, check out my previous post where I covered the fundamentals.

🍜 Definition Change in Regulatory Terms

The new draft introduces several modifications, additions, and clarifications to regulatory terms.

These updates show NMPA’s intention to stay closer in step with international regulators. So, what’s actually changing?

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.

 🍜 Renaming of Product Categories

This part matters if you manufacture surgical instruments used in reproductive or contraceptive procedures.

The updated naming will guide you in classifying your products more accurately. So, what’s new here?

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 has finally clarified the product category for reusable instruments that support reproductive and contraceptive devices.

Why? These instruments are often misunderstood and misclassified.

Think about reusable surgical tools used to insert or remove IUDs, or for vasectomy and hysterectomy procedures.

At first glance, you might think they belong to the category of assisted reproductive and contraceptive devices. If so, they’d fall under Class II.

But that’s not correct! These are not classified under assisted reproductive and contraceptive devices.

These are reusable surgical instruments. Their role is only to assist the operation. They don’t directly enable reproduction or contraception.

That’s why they are classified as Class I medical devices.

Why does this matter?

A wrong classification can throw off your entire regulatory strategy.

• You lose time and money trying to meet the wrong requirements.

• You risk introducing extra hurdles that don’t even apply to your product.

The updated classification rules aim to prevent exactly this kind of mistake.

🍜 Change of Classification Principles

NMPA also proposed revisions to reduce grey zones and introduce stricter rules under the classification principles.

Some key updates to Article 6 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?

Changes in definitions and classification principles can shift the risk class of your device.

The new draft aims to bring clearer rules that tighten safety and performance requirements of the medical devices.

It’ll also reduce the area of grey zones and provide more certainty on the edges.

If your product category is affected, you should:

• Review your intended use and accessory list

• Re-check your classification

• Update your clinical and technical files if the definition change impacts your risk profile

After the new classification rules are finalized, NMPA will also update the catalogue list.

If you’re preparing for registration or planning to launch a new product in a grey zone, now is the time to act.

Any questions about NMPA registration? Let’s connect. You can now book a call with me directly below.

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.