We’re already halfway through the first quarter.

It’s a busy month, even with a one-week Lunar New Year break.

Happy belated Lunar New Year to those who celebrate, no matter where you are.

Welcome to the Year of the Fire Horse 🐎

Keep up with China's regulatory changes.

Stay compliant with Medtech Chopsticks without having to dig through dozens of notices.

🍜 Regulation Update

NMPA didn’t publish new medical device regulations in February.

But, NMPA did set the new direction for 2026 with an enforcement plan.

It matters if you’re asking: What will inspectors care about this year?

🍜 Regulatory Enforcement Plan for 2026

The NMPA laid out its priorities for the year:

NMPA wants to keep improving the regulatory framework and standards system.

This will help build a stronger supervision capability.

Also, China is in the innovation-driving seat.

Immense support is poured into innovation, especially in the development and clinical stages for innovative devices.

The government aims to enhance the quality and efficiency of the registration and filing process.

This includes regulatory consistency on how standards get applied.

Safety risks are also a focal point in 2026.

What does this mean?

NMPA is doubling down on full lifecycle supervision, especially post-market surveillance.

Inspections will focus more on actual production and operating practices, not just your SOPs.

Inspectors will look for specific risks and follow the trail where they suspect non-compliance or illegal activity.

Use it as an indicator for your 2026 audit planning.

Furthermore, international cooperation is also picking up.

One clear example is the Malaysia-China Medical Device Regulatory Reliance Programme, launched as a pilot in 2025.

At the government level, Germany’s Chancellor Friedrich Merz is in China this week to strengthen the China-Germany relationship.

🍜 Guidance Documents

February came with a big drop of registration review guidance.

In total, 14 guidance documents were released.

Here are the highlights.

🍜 Light-cured Calcium Hydroxide Indirect Pulp Capping Material

The scope excludes sodium hydroxide cements, non-curing materials, and active-substances.

It requests full formulation disclosure. You must split registration units when the core chemistry or performance changes.

Key performance expectations include: pH ≥ 8.0, content control of calcium hydroxide, curing depth/time, strength, light sensitivity, calcium release, and sealing.

Impact

Expect tighter CMC and bench review.

If you deviate from YY/T 0824 or standard methods, you need a clear scientific justification.

 🍜 Cranio-maxillofacial Internal Fixation System

This guideline emphasizes on component configuration, dimension drawings/tolerances, material grade, and packaging/sterility integrity.

Impact

This pushes traceability deeper into the technical file.

It also raises the bar for plate and screw verification, especially worst case testing.

🍜 Elbow Prosthesis System

The guideline applies to constrained and semi-constrained hinged total elbow systems.

It expects detailed drawings and a clear anatomical fit rationale.

Non-clinical evidence on the materials, coatings, locking reliability, range of motion, wear, and fatigue is needed for worst-case configurations.

Impact

Plan for strong evidence on safety aspect and evaluate your worst-case selection logic.

🍜 Hip Prosthesis System

The draft consolidates expectations for materials coatings, surface hardening layers, and additive manufacturing porous structures.

Different tests include wear test, acetabular locking strength, deformation test, stem fatigue per CT ranges, and evidence for coatings and surface hardening layers is expected.

Impact

Manufacturers should pay attention to the material master data, process control.

🍜 Dental Fiber Posts

The revision targets Class III prefabricated, semi-prefabricated, and CAD/CAM integrated post-core systems.

It tightens expectations for drawings, tolerances, plus full composition disclosure.

It also emphasizes factors that affect performance in real clinical use.

 Impact 

Ensure your claims match validated mechanical and bonding data.

Strengthen process controls to show consistent output across batches.

🍜 Calcium Phosphate / Silicon-based Bone Graft Substitute

This guideline expects strong physicochemical characterization, including pore structure, heavy metal limits, and clinically relevant handling properties.

Animal studies are usually expected unless you can show strong equivalence to a China marketed product.

Impact

Plan longer for non-clinical timelines.

You need degradation and bone ingrowth evidence, especially for new composites or processes.

🍜 Laparoscopic Stapler and Cartridges

The revision clarifies classification, registration-unit splitting by design, staple material, staple form, and cartridge architecture.

It emphasizes risk management, usability engineering, worst-case bench performance, biological evaluation, sterility, packaging/transport stability, and MR compatibility for implanted staples.

Impact

Strengthen your tissue thickness and cartridge matching rationale.

Keep material and surface documentation traceable.

🍜 Sodium Hyaluronate Injectable Dermal Filler

The revision demands formulation disclosure, crosslink degree/particle size characterization, degradation metabolism, biocompatibility, sterilization, and shelf-life testing.

Impact

CMC scrutiny will increase.

Weak degradation logic or poor residual control will trigger major deficiencies.

🍜 Single-use Peripheral Nerve Block Puncture Needle

The guideline covers ultrasound-visible designs, insulated needles, and catheter options.

It requires detailed design control, compatibility with nerve stimulatorand ultrasound, and robust bench verification.

Impact

Dossiers must demonstrate coating safety, device-accessory compatibility, and worst-case validations.

🍜 Nanomaterial Devices

This part formalizes New Approach Methodologies (NAMs) and and modeling or simulation for nanomaterial device risk assessment.

It requires fit-for-purpose justification, validation, defined boundaries, and uncertainty analysis.

Impact

You can use organoids, chips, and IVIVE models, but validation needs to be strong.

🍜 Polyurethane Foam Dressing

The revision expands nonclinical expectations.

Thisasks for full material disclosure, chemical characterization, performance linked to intended wound types, sterility, endotoxin control, packaging and shelf-life integrity.

It clarifies when clinical evaluation is exempt versus required.

Impact

Manufacturers must focus on chemical safety and align claims strictly to the evidence.

Refer to the CMDE website for the full list of published guidance documents.

🍜 Guidance Drafts

February also brought a big batch of drafts.

A total of 33 registration review guidance drafts were published as follows:

Surgery

• Surgical power equipment

• Surgical microscopes

• Insufflators

• Anesthesia laryngoscopes

Patient Monitoring

• Telemetry patient monitoring systems

• Pulse oximeters

• Electronic clinical thermometers

• Medical temperature control devices

IVDs

• Carbon dioxide assay reagents

• Valproic acid test reagents (TDM)

• Digoxin test reagents (TDM)

• Carbamazepine test reagents (TDM)

• ALT (alanine aminotransferase) assay reagents (rev. 2025)

• Homocysteine assay reagents (rev. 2025)

• Insulin assay reagents (rev. 2025)

• C-peptide assay reagents (rev. 2025)

• D-dimer assay reagents, immunoturbidimetry (rev. 2025)

• Adenosine deaminase (ADA) assay reagents

• Lactate test reagents

• Platelet analyzers

Dentistry

• Dental handpieces

• Dental implant planning software

Gastrointestinal

• Electric gastric lavage machines

• TCM tongue diagnosis devices

Hospital Infrastructure

• Electric hospital beds

• Electric operating tables

• Anti-decubitus (pressure ulcer) air mattresses

Others

• Vertical pressure steam sterilizers

• Medical molecular sieve oxygen generation systems

• Electronic colposcopes

• Tonometers

• Cryotherapy analgesia devices

• Magnetocardiography (MCG) signal acquisition devices

🍜 List of Standards

This section covers 39 new draft standards. I grouped them by category so you can scan faster.

🍜 AI

• Performance Testing Methods for Algorithms of AI Medical Device Ultrasound Image-Assisted Analysis Software

• Testing Methods for Algorithms of AI Medical Device ECG Assist Analysis Software

🍜 Ophthalmology

• Ophthalmic Optics - Contact Lenses - Part 4: Standard Salt Solutions for Testing

• Part 5: Test Methods for Optical Performance

• Part 6: Mechanical Performance Test Methods

• Part 7: Test Methods for Physicochemical Properties

• Evaluation of Disinfection Efficacy of Contact Lens Care Products - Part 2: Method for Evaluating Efficacy Against Acanthamoeba Trophozoites

• Ophthalmic Optics - Intraocular Lenses - Part 1: Terminology

• Part 2: Optical Properties and Test Methods

🍜 IVDs

• Information (Labeling) Provided by the Manufacturer - Part 1: Terms, Definitions and General Requirements

• Part 2: IVD Reagents for Professional Use

• Part 3: IVD Instruments for Professional Use

• Part 4: IVD Reagents for Self-Testing

• Part 5: IVD Instruments for Self-Testing

• Clinical Laboratory Testing and IVD Devices - Requirements for Self-Testing IVD Monitoring Systems for Oral Anticoagulant Therapy

• Multiplex Nucleic Acid Molecular Detection - Part 2: Verification and Validation

• Requirements for Specimen Collection and Transport for Medical Laboratories

• Clinical Chemistry IVD Reagent Kits

• Luteinizing Hormone (LH) Test Kit (Immunochromatography Method)

• Guidance on Application of ISO 15189 in Clinical Pathology for Medical Laboratories

• Molecular In Vitro Diagnostic Testing - Pre-analytical Processing Technical Specification for Circulating Tumor Cells (CTCs) in Venous Whole Blood - Part 1: RNA Isolation

• Point-of-Care Testing (POCT) Devices - Requirements and Recommendations for Supervisors and Operators

• Medical Laboratories - Requirements for Quality and Competence - Part 5: Requirements for the Field of Clinical Immunology Testing

• Medical Laboratories - Requirements for Quality and Competence - Part 4: Requirements for the Field of Clinical Chemistry Testing

• Medical Laboratories - Requirements for Quality and Competence - Part 7: Requirements for the Field of Transfusion Medicine

• IVD Medical Devices - Multiplex Nucleic Acid Molecular Detection - Part 3: Interpretation and Reporting

• Medical Laboratories - Requirements for Quality and Competence - Part 2: Requirements for the Field of Clinical Hematology Testing

• Medical Laboratories - Requirements for Quality and Competence - Part 6: Requirements for the Field of Clinical Microbiology Testing

• Technical Specification for 3D Bioprinting Used in Tumor Drug Sensitivity Testing - Part 2: Model Identification and Quality Control Specification

• Medical Laboratories - Requirements for Quality and Competence - Part 3: Requirements for the Field of Urinalysis Testing

• Biological Risk Management for Laboratories and Related Organizations

• Technical Specification for 3D Bioprinting Used in Tumor Drug Sensitivity Testing - Part 1: Tissue Sampling and Pre-processing Procedures

• General Principles for Evaluation of Methods for Extraction and Purification of Extracellular Vesicles

• Point-of-Care Testing - Requirements for Quality and Competence

• Tumor Marker Quantitative Assay Reagent Kits (Labeled Immunoassay Method)

• Molecular In Vitro Diagnostic Testing - Pre-analytical Processing Specification for Circulating Tumor Cells (CTCs) in Venous Whole Blood - Part 3: Preparation for CTC Staining and Analysis

• Considerations for IVD Medical Device Manufacturers in Public Health Emergencies

• Molecular In Vitro Diagnostic Testing - Pre-analytical Processing Technical Specification for Circulating Tumor Cells (CTCs) in Venous Whole Blood - Part 2: DNA Isolation

Please refer to the official NIFDC notice for the formal release and the full draft texts.

That’s it for February.

🍜 Why Medtech Chopsticks?

Medtech Chopsticks helps small or mid-sized manufacturers to navigate China’s complex regulatory framework.

We offer consultations for tuning your China strategy, registration pathway, and compliance risk.

What matters to your business and your stakeholders? We prioritize.

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.