Starting this month, I’m rolling out a monthly China regulatory recap.

I’ll publish it in the last week of each month.

My goal is simple.

I want to help manufacturers and innovators keep up with China regulatory changes and medtech trends, without having to dig through dozens of notices.

Each recap will cover what’s new, a summary with its impact, and what you should do next.

Stay strategic and stay compliant with Medtech Chopsticks.

🍜 Regulation Update

China started 2026 with a busy month.

NMPA has been striving for cleaner classifications, submission requirements, and standards you can actually test against.

Let’s see what moved in January.

🍜 New Medical Device Classification Catalogue

Summary
NMPA updated the classification catalogue across 31 device codes.

The changes took effect on January 4, 2026.

Updates cover product descriptions, intended use, device examples, and risk class.

The risk classes of several codes were split.

Some devices were moved up in risk class, while others moved down.

The impacted areas include surgical devices, respiratory devices, implants, dental devices, infusion products, assisted reproduction devices, and IVDs.

Impact
If your products fall under any of the affected codes, review your product description, claims, and classification before you submit anything new.

Also, check what this means for existing registrations.

Some products may need updates when you renew or change your certificate.

I shared a deeper breakdown in my earlier post.

🍜 Regulation on the Selection of Medical Device Re-testing Laboratories (Draft)

Summary
NMPA released a draft rule to standardize how re-testing laboratories are selected.

This applies when a company challenges a testing result and wants a re-test.

The request must be submitted within the required timeframe.

Impact
The draft sets clearer and stricter expectations for lab qualifications, testing capability, and legal accountability.

This may change how teams plan testing, especially if your product has borderline results or higher-risk test items.

It also raises the bar for how you handle disputes. You will need tighter and better documentation to support any re-test request.

🍜 Guidance Documents

🍜 Endotracheal Intubation Products

Summary
Released a review guidance for endotracheal intubation products.

This covers endotracheal tubes and other non-active intubation products.

Impact
The new guidance document has a tighter requirement on the performance data, usability evidence, and compatibility rationale.

It’s recommended to update your submission checklists and map the testing matrix.

 🍜 Human Leukocyte Antigen (HLA) Genotyping Detection Reagents

Summary
This guidance targets Class III IVD reagents that qualitatively detect HLA genes from human venous whole blood using nucleic acid methods for HLA genotyping.

The intended use supports donor-recipient matching for hematopoietic stem cell transplantation and solid organ transplantation, such as liver and kidney.

Impact
NMPA is looking at the full system, not just the reagent.

Plan to disclose your complete setup, including the instrument, the end-to-end workflow, DNA extraction reagents, sequencing reagents if you use NGS, and any dedicated software or databases.

The guidance also sets clearer expectations for study design and clinical evidence.

That includes trial setup, number of sites, sample size, and accuracy metrics. Make sure your labeling claims line up with what your data can actually support.

🍜 Transcatheter Mitral Valve Clip Systems (Draft)

Summary
This draft guidance sets dossier expectations for Class III transcatheter mitral valve clip.

It covers the naming, registration unit splitting, design inputs tied to anatomy and use path, and detailed risk analysis.

Impact
The focus is on nonclinical evidence, especially hydrodynamics, simulated use, corrosion, and durability testing to 400 million cycles (about 10 years), plus method validation.

It calls for full biocompatibility, packaging shelf life, SAL 10⁻⁶ sterility, and animal studies when needed.

If you are in the cardiovascular field, you have the opportunity to define what “good enough” looks like before the guidance is published.

🍜 List of Standards

This section covers new draft standards and planned standard revisions.

I grouped them by category to make scanning easier.

🍜 Anesthesia and Respiratory

• Anesthesia and respiratory equipment air entrainment devices

• Anesthesia and respiratory equipment - breathing therapy tubes and connectors

• Terminology for Anesthesia and Respiratory Equipment

• Medical Liquid and Gas Small Orifice Connections - Part 20: General Test Methods

• Medical Liquid and Gas Small-Aperture Connectors - Part 5: Connectors for Limb Airbag Inflation Applications

• Medical Liquid and Gas Small Orifice Connections - Part 1: General Requirements

• Medical Liquid and Gas Small Orifice Connections Part 2: Connections for Respiratory Applications

• Hollow fiber membrane for extracorporeal oxygenation

🍜 Dentistry

• Nomenclature of Oral Malformations in Dentistry, Part 1: Standard Representation of Oral Malformations

• Dental Nomenclature of Oral Malformations, Part 2: Dental Developmental Abnormalities

• Titanium and Titanium Alloy Dental Implants

• Dental Diamond Rotating Instruments Part 1: General Requirements

• Dental Diamond Rotating Instruments Part 2: Cutting Discs

• Mobile dental treatment machines and dental chairs Part 1: General requirements

• Dental Mobile Treatment Machines and Dental Chairs Part 2: Air, Water, Suction, and Wastewater Systems

• YY/T 1692-2020: Dentistry Hot Melt Gutta-Dental Filling Machine

🍜 Surgical

• Surgical Implant Metallic Materials Part 4: Cast Cobalt-Chromium-Molybdenum Alloys

• General requirements for passive surgical implants

• Surgical implant β-tricalcium phosphate powder

🍜 Sterility

• Aseptic processing of medical products - Part 1: General requirements

• Microbiological Methods for Sterilization of Medical Products Part 3: Bacterial Endotoxin Testing

🍜 Neurology

• Hemodialysis and Related Equipment Online Clearance and Dialysis Adequacy Testing Methods

• Polyethersulfone hollow fiber membrane for hemodialysis machines

• Single-use dialysis indwelling needle

• Relative blood volume testing methods for hemodialysis and related equipment

• Filter and tubing for continuous renal replacement therapy

🍜 Others

• Basic Model for Information Integration of Medical Equipment

• General Rules for the Classification of Medical Devices Using Brain-Computer Interface Technology

• Special Technical Requirements for Digital Therapeutic Medical Devices

Also, NIFDC released several standard revision workplans for 2026 and 2027.

For 2026, the proposed standards work focuses on the following areas.

• AI-driven medical device (revisions and formulations)

• Brain-computer interface technology

• Robotic

• Surgical instruments

• ISO/TC 194 standard

• ISO/TC 76 standard

The direction is obvious. China is doubling down on AI and robotics in 2026.

As for 2027, NIFDC flagged a wider set of fields where standards may be proposed, such as:

• Medical device packaging

• Biological evaluation of medical devices

• Medical device quality management and general requirements

• Active and cardiovascular implantable devices

• AI-based medical device

• Medical robots

• Physical therapy

• Anesthesia and respiratory equipment

• Dental equipment and instruments

• Medical optics

• Medical infusion and syringes

• Medical electroacoustic equipment

• Medical clinical laboratory and In Vitro diagnostic systems

• Contraceptive, human-assisted reproductive, and obstetric technology

• Surgical implants and orthopedic devices

• Medical additive manufacturing technology

• Medical protective equipment

For 2027, keep an eye on packaging, biological evaluation, and quality management requirements.

These three areas often ask for test reports and document evidence, even when your product design has not changed.

Another thing to watch is the biological evaluation.

China is moving closer to ISO 10993, but there may still be China-specific details you need to align.

Do not assume your existing biocomp package will map cleanly.

If you plan to register or sell in China, treat standards workplans as early warning signals.

Standards are often the quiet reason your next renewal or registration change suddenly needs new testing.

Check the official NIFDC website for the full list.

That’s it for January.

🍜 Why Medtech Chopsticks?

Medtech Chopsticks helps small or mid-sized manufacturers to navigate China’s complex market and connect with trusted partners.

We listen and focus on what matters to your business and your stakeholders.

We analyze what affects your strategy, registration path, and compliance risk.

Running into issues with market strategies, registrations, or compliance requirements?

Book your intro call here.  

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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. 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.