Wrapping up the year.

This is a special series for you, RA and QA folks.

Quality and Regulatory sit right at the front line.

We work with cross-functional teams to ensure medical devices are safe and effective.

And yes, we’re the firefighters when something goes wrong.

I’m sharing a roundup of the most important regulatory updates from 2025, so you can plan for 2026.

Note: this list covers the major updates, but it’s not exhaustive.

🍜 Regulatory Updates

Here’s my shortlist of the biggest 2025 regulatory updates that touch regulatory and quality aspects in China.

I focused on what matters most if you’re a foreign manufacturer.

Quality & Manufacturing

• Announcement on the Good Manufacturing Practices for Medical Devices (detailed analysis in English) - To be effective in November 2026

• Announcement on the local manufacturing for imported devices in China (relevant analysis in English)

• Regulation for Quality Management of Online Sales of Medical Devices (Detailed analysis in English)

• Guidance document for on-site inspection for online sales

Classification

• Announcement on the product catalog of the high-end devices with priority review - Published on December 24th 2025, and effective immediately

• Draft on the medical device classification rules (detailed analysis in English)

• Draft on the revision of medical device classification rules

Clinical Evaluation

• Notice on the updated clinical-evaluation exemption catalog for medical devices (detailed analysis in English)

• Notice on the updated clinical-evaluation exemption catalog for IVDs

Testing

• Guidance document on the Inspection of Self-testing for Medical Device Registration (Detailed analysis in English)

Unique Device Identification (UDI)

• Drafts on the UDI Implementation of Medical Devices in Specific Situations and Subsequent Products (Detailed analysis in English) - to be effective in Jun 2027 and 2029, respectively

Let’s chat if you need support mapping these changes to your existing processes.

🍜 List of Guidance Documents

Around 100 product-specific guidance documents were published in 2025.

Due to the limitation, below is a snapshot of the latest 50 guidance documents.

Patient Monitoring & Cardiology

• Guidance Registration Review of Patient Monitoring Products (Class II)

• Guidance Registration Review of Ambulatory Blood Pressure Monitors

• Guidance Registration Review of Ultrasonic Doppler Fetal Monitors

• Guidance Registration Review of Electrocardiograph (ECG) Products

• Guidance Registration Review of Dynamic Electrocardiographs

Infusion & Suction

• Guidance Registration Review of Infusion Pumps

• Guidance Registration Review of Medical Electric Suction Devices

• Guidance Registration Review of Medium-Frequency Electrotherapy Products

Imaging

• Guidance Registration Review of Infrared Therapy Equipment

• Guidance Registration Review of Carbon Dioxide (CO₂) Laser Therapy Equipment

• Guidance Registration Review of Surgical Shadowless Lamps (Operating Lights)

• Guidance Registration Review of Single-Use ECG Electrodes

• Guidance Registration Review of Infrared Breast Examination Devices

• Guidance Registration Review of Ultrasonic Therapy Equipment

Endoscopy

• Guidance Registration Review of Rigid Optical Endoscopes (Natural Orifice Type)

• Guidance Registration Review of Flexible Fiber Endoscopes

• Guidance Registration Review of Class II Laparoscopic Surgical Instruments

• Guidance Registration Review of Laparoscopic Surgical Systems, Part 4: Risk Management

• Guidance Registration Review of Balloon Inflation Devices for Intravascular Balloon Dilatation Catheters

• Guidance Registration Review of Hysterosalpingography Balloon Catheters

• Guidance Registration Review of Endoscopic Surgical Scissors

Implants

• Guidance Registration Review of Absorbable Bone Internal Fixation Implants

• Guidance Registration Review of Antibacterial Performance Evaluation of Orthopedic Implants

• Guidance Registration Review of Intracranial Thrombectomy Stents

In-vitro Diagnostics

• Guidance Registration Review of HLA-B*27 gene detection reagent

• Guidance Registration Review of Stability Studies for In Vitro Diagnostic Reagents

• Guidance Clinical Trial Registration Review of Colorectal Cancer-Related Gene Methylation Detection Kits

• Guidance Registration Review of High-Risk HPV Nucleic Acid Detection and Genotyping Reagents

Others

• Guidance Registration Review of Single-Use Anesthetic Needles

• Guidance Registration Review of Visual Field Analyzers (Perimeters)

• Guidance Registration Review of Infrared Ear Thermometers

• Guidance Registration Review of Hemorheology Analyzers

• Guidance Registration Review of Single-Use Sterile Urethral Dilators

• Guidance Registration Review of Skull Repair Mesh System

Please check the Center of Medical Device Evaluation’s website for the full list of guidance documents and drafts.

🍜 List of Standards

In 2025, the National Institutes for Food and Drug Control (NIFDC) published over 80 standards.

Another 87 standard drafts and 180 standard projects are still in the pipeline for 2026 and beyond.

Below is the list of published standards, grouped by category to make it easier to scan.

General

• YY/T 1960-2025 Medical Devices-Information Provided by the Manufacturer

Brain-computer Interface

• YY/T 1987-2025 BCI device terminology industry standard

• YY/T 1996-2025 Test Method for Sensing and Response Performance of Implantable Neurostimulators with Closed-Loop Function Using BCI Technology

Artificial Intelligence & Robotic

• YY/T 1990-2025 Artificial Intelligence Medical Devices - Algorithmic Performance Testing Methods for Cellular Pathology Image Analysis Software

• YY/T 1991-2025 Artificial Intelligence Medical Devices - Algorithmic Performance Testing Methods for Stroke CT Image Analysis Software

• YY/T 1992-2025 Robotic-Assisted Surgical Devices - Summative Usability Testing Methods

• YY/T 1993-2025 Robotic-Assisted Surgical Devices Reliability Verification Methods

• YY/T 1994-2025 Robotic-Assisted Vascular Intervention Surgical Control Systems

• YY/T 1973-2025 Medical Lower Limb Exoskeleton Robots

Sterile

• YY/T 0497-2025 Sterile Disposable Insulin Syringes

• YY/T 0573.2-2025 Sterile Disposable Syringes-Part 2: Syringes for Power-Driven Injection Pumps

• YY/T 0573.3-2025 Sterile Single-Use Syringes-Part 3: Self-Destructing Fixed-Dose Vaccine Syringes

• YY/T 0573.4-2025 Sterile Single-Use Syringes-Part 4: Syringes Preventing Reuse

• YY/T 1980-2025 Single-Use Sterile Incision Protective Covers

Orthopedic

• YY/T 0651.4-2025 Joint Replacement Implants-Wear of Total Hip Prostheses-Part 4: Testing of Hip Prostheses Under Edge-Loading Conditions Due to Component Positioning Changes

• YY/T 0958.1-2025 Orthopedic Drilling Instruments-Part 1: Drills, Taps, and Countersink Drills

Neurology

• YY/T 1670.2-2025 Evaluation of Neurotoxicity of Medical Devices-Part 2: Neurocytotoxicity Tests

• YY/T 0685-2025 Neurosurgical Implant Devices-Self-Closing Intracranial Aneurysm Clips

• YY/T 1986-2025 Single-Use Sterile Neurological Catheters and Accessories

• YY/T 1961-2025 Survival Motor Neuron (SMN) Detection Kit

Respiratory

• YY/T 1610-2025 Anesthesia and Respiratory Equipment-Passive Humidifiers

• YY/T 0337-2025 Anesthesia and Respiratory Equipment-Endotracheal Tubes and Connectors

• YY 9706.287-2025 Medical Electrical Equipment Part 2-87: Particular Requirements for Basic Safety and Essential Performance of High-Frequency Ventilators

Imaging

• YY/T 1959-2025 Specific Technical Requirements for Intraoral Digital X-ray Imaging Systems

• YY/T 0310-2025 General Technical Requirements for X-ray Computed Tomography Equipment

• YY/T 1975-2025 Far-Infrared Magnetic Therapy Patches (Pouches)

• YY/T 1981-2025 Radiotherapy Planning Software: Requirements and Test Methods for Accuracy of Electron Beam Dose Calculation

• YY/T 0910.2-2025 Medical Electrical Equipment-Medical Imaging Display Systems-Part 2: Acceptance and Stability Tests for Medical Imaging Display Systems

Tissue Engineering

• YY/T 1985-2025 Tissue Engineering Medical Devices-Collagen

• YY/T 1995-2025 Tissue Engineering Medical Devices Evaluation Tests for Cell Biology Effects of Cartilage Scaffolds

• YY/T 1955-2025 Tissue Engineering Medical Devices Collagen Terminology

• YY/T 1954-2025 Recombinant Collagen Peptide Fingerprint Spectrum Analysis

Surgical

• YY/T 0474-2025 Surgical Implants-Polylactic Acid Homopolymers, Copolymers, and Blends-In Vitro Degradation Testing

• YY 0989.6-2025 Surgical implants Active implantable medical devices Part 6: Specific requirements for active implantable medical devices for the treatment of rapid arrhythmias (including implantable defibrillators)

• YY/T 1982-2025 Surgical Implants - Test Methods for Morphological Characteristics of Porous Structures

• YY 0459-2025 Surgical Implants Acrylic Resin Bone Cement

• YY/T 1924-2025 Surgical Implants Nickel-Titanium Shape Memory Alloy Cord Material

• YY/T 1934-2025 Ergonomic Design Requirements and Evaluation Methods for Orthopedic Implants and Surgical Instruments

Dentistry

• YY/T 1637-2025 Dentistry Magnetic Attachments

• YY/T 0915-2025 Dentistry-Orthodontic Brackets and Buccal Tubes

• YY/T 1983-2025 Dentistry Zirconia Dental Implants-Dynamic Fatigue Testing

• YY 0300-2025 Dentistry Artificial teeth for restoration

• YY 0710-2025 Dentistry Polymer-based crown and veneer materials

• YY/T 0528-2025 Dentistry-Corrosion Test Methods for Metallic Materials

• YY/T 1965-2025 Dentistry-Surgical Handles for Oral Surgery

• YY/T 1966-2025 Dentistry-Contra-Angle Filling Devices

• YY/T 1972-2025 Dentistry Soft Tissue Circumcision Knife

• YY/T 1974-2025 Dentistry Multifunctional Spray Gun

• YY/T 1978-2025 Dentistry Ring Drills

Cardiohematology

• YY 0781-2025 Blood Pressure Sensors

• YY/T 1945-2025 Blood Thawing Equipment

• YY 0948-2025 Cardiopulmonary bypass systems Single-use arterial and venous cannulae

• YY 0267-2025 Extracorporeal Circulation Systems for Blood Purification: Extracorporeal Circulation Blood/Fluid Pathways for Hemodialyzers, Hemofiltrators, Hemofilters, and Blood Concentrators

Sport Medicine

• YY/T 0965-2025 Sports Medicine Implant Devices-Specific Requirements for Artificial Ligaments

• YY/T 1988-2025 Sports Medicine Implant Devices Meniscus Suture Systems

In-vitro Diagnostics

• YY/T 1962-2025 Aldosterone Assay Kit (Chemiluminescent Immunoassay)

• YY/T 1963-2025 Colorectal Cancer-Related Gene Methylation Detection Kit (Fluorescent PCR Method)

• YY/T 1964-2025 Tacrolimus Assay Kit

• YY/T 1967-2025 Flow Cytometry Array Analyzer

• YY/T 1969-2025 Microalbumin Assay Kit (Immunoturbidimetric Method)

• YY/T 1970-2025 Lipoprotein-Associated Phospholipase A2 Assay Kit (Chemiluminescent Immunoassay Method)

Reproductive

• YY/T 1567-2025 Female Condoms-Technical Requirements and Test Methods

• YY/T 1968-2025 Preimplantation Embryo Chromosomal Aneuploidy Analysis Software

• YY/T 1989-2025 Medical Devices for Human Assisted Reproductive Technology Determination of Sucrose, Glucose, Trehalose, and Fructose in Assisted Reproductive Fluids

Others

• YY/T 0764-2025 Ophthalmic Instruments-Projection and Electronic Visual Acuity Charts for Measuring Visual Acuity

• YY/T 1469-2025 Portable Electric Infusion Pumps

• YY/T 1274-2025 Peritoneal Dialysis Equipment

To read more about each standard, please visit the NIFDC Standard database.

I hope this roundup gives you a quick overview.

🍜 Afterthought

Dear RA/QAs,

What you do matters.

You review documents thoroughly. You catch issues early. You push for corrective actions.

You stop problems before devices ever reach hospitals or end-users.

Lower risks. Safer devices. Better outcomes.

More lives were helped.

So give yourself some credit for what you delivered in 2025.

Wishing you a strong start to 2026 🎉

Book a preliminary call here to get your China market entry strategy ready for 2026.

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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.