New NMPA Guideline Defines Registration Requirements for IVUS Systems and Catheters

On April 13, 2026, theChina’s Center for Medical Device Evaluation (CMDE) published the firstdedicated regulatory framework for reviewing intravascular ultrasound (IVUS)diagnostic systems and catheters in China — “Guideline for Registration Reviewof Intravascular Ultrasound Diagnostic Devices.”

For manufacturerspursuing China medical device registration, the guideline clarifies the technicalstandards, registration unit classification rules, and clinical evaluationpathways applicable to IVUS products entering the Chinese market.

A NewRegulatory Framework for IVUS Devices in China

Intravascular ultrasound plays a critical role in cardiovascularinterventions by enabling high-resolution imaging inside blood vessels. Despiteits clinical importance, China previously lacked a dedicated registrationreview guideline specifically addressing IVUS diagnostic products.

The newly releasedguideline addresses this regulatory gap by introducing a structured frameworkfor evaluating IVUS medical devices under China medical device regulation. Itdefines the core elements manufacturers must address during the NMPA review process,including:

• Technical performance indicators
• Testing expectations
• Clinical evaluation pathways
• Documentation requirements

For overseas manufacturers planning IVUS registration in China, theguideline improves regulatory clarity while also establishing more detailedcompliance expectations. Companies must now carefully consider factors such asregistration unit classification, coating material studies, animal testingdesign, and clinical evaluation strategies.

Scopeand Registration Unit Classification

To clarify how IVUS products should be evaluated during regulatoryreview, the guideline first defines the scope of devices covered:‍

• IVUS consoles
• Patient interface units (PIU/withdrawal motors),
• Single-use IVUS diagnostics catheters
• Related accessories, including devices that integrate additional diagnostictechnologies such as optical coherence tomography (OCT) or fractional flowreserve (FFR) functions

Within this scope,manufacturers may register IVUS systems and catheters either together as anintegrated system or separately. However, the guideline introduces detailedrules governing how registration units must be defined, which directly affectsNMPA submission strategy.

Classification of Catheters and System Configurations

Because IVUS systems may be configured in multiple ways, the guidelineestablishes specific rules for grouping devices and catheters into registrationunits. These requirements vary depending on whether components are registeredtogether or independently.

These classification rules are particularlyimportant for manufacturers managing global product portfolios, as registrationunit strategy directly affects submission planning, regulatory timelines, andtesting requirements for IVUS registration in China.

Medical Device Classification and Naming Rules

Beyond defining registration units, the guideline also clarifies theregulatory classification and naming conventions applicable to IVUS products.

IVUS products areclassified as Class III medical devices, reflecting their high-risk designationwithin China’s medical device regulatory framework.

The guidelinespecifies the following classification codes

• 06-07-01: IVUS systems or systems registered together with catheters
• 06-08-04: IVUS catheters registered independently

In addition,product names must comply with the “Guideline for Naming Generic Names ofMedical Devices.” The naming rules require clear differentiation betweencoronary-specific catheters, peripheral-specific catheters, and general-purposecatheters.

Technical Performance Requirements and Supporting Studies

The guideline establishes detailed technical performance indicators forboth IVUS devices and catheters.

Both IVUS consoles and catheters must meetdefined ultrasound imaging performance indicators based on YY/T 1659 andrelated Chinese medical device standards.

Key performance parameters include:

• Acoustic operating frequency
• Imaging radius
• Axial resolution
• Lateral resolution
• Geometric position accuracy
• Image geometric distortion

All adjustable catheter pullback speeds must also meet these imagingperformance requirements to ensure consistent diagnostic performance.

Device Safety, Software, and Structural Requirements

In addition to imaging performance, the guideline specifies broadertechnical requirements covering device structure, system stability, andsoftware functionality.

Catheters must complywith standards such as YY 0285.1, covering radiopacity, peak tensile force,leak resistance, chemical properties, sterility, and bacterial endotoxinlimits. Device requirements include indicators for:

• Appearance and structure
• Connection stability
• Software functionality
• Usage restrictions
• Access control

For acoustic energysafety, in addition to compliance with GB 9706.237, limits must be specifiedfor:

• Mechanical index (MI)
• Thermal index (TI)
• Spatial-peak temporal-average intensity
• Spatial-peak pulse-average intensity

These requirementsensure IVUS systems meet established safety standards for ultrasound energyexposure.

Lubricious Coating Study Requirements

For IVUS catheters with lubricious coatings, the guideline introducesadditional documentation requirements.

Manufacturers mustsubmit coating study data in accordance with the “Guideline for RegistrationReview of Vascular Interventional Devices with Lubricious Coatings.”

Required evidenceincludes:

• Coating integrity testing
• Lubricity performance evaluation
• Particle quantification following simulatedclinical use

These studies are intended to demonstrate that catheter coatingsmaintain performance and do not release harmful particulate matter duringclinical use.

Biological Safety Evaluation

Alongside coating validation and technical testing, the guidelinerequires comprehensive biological safety evaluation for IVUS catheters.

Required testing includes

• Cytotoxicity
• Sensitization
• Irritation or intracutaneous reactivity
• Pyrogenicity
• Acute systemic toxicity
• Hemocompatibility, including hemolysis,coagulation, and thrombogenicity

Together, these tests confirm the biocompatibility of materials used incatheter construction and ensure compliance with China medical device safetystandards.

Clinical Evaluation Pathways for IVUS Products

Beyond non-clinical testing, manufacturers must also determine theappropriate clinical evaluation pathway for IVUS product registration.

The guideline allowsstandard coronary or peripheral IVUS systems and catheters to rely on predicatedevice comparison when safety and effectiveness can be adequately demonstratedthrough non-clinical data.

However, this pathwaydoes not apply to all product configurations.

WhenClinical Trials Are Required

Clinical trials should be conducted when a product incorporates:

• A completely new design
• Significantly different technical parameters
• Features that cannot be sufficiently validated through non-clinical testing

In addition, the guideline explicitly requires clinical data for certainadvanced functions, including:

• Plaque characterization algorithms
• IVUS-based fractional flow reserve (FFR) calculations

Manufacturers developing these advanced features should anticipateclinical study requirements during early product development.

AnimalTesting and Product Stability Requirements

Animal testing should evaluate:

• Device maneuverability
• Image quality
• Measurement accuracy
• Overall procedural safety

For coronary IVUS systems, testing must cover the threeprimary coronary arteries:

• Right coronary artery
• Left anterior descending artery
• Left circumflex artery

Peripheral IVUS studies should focus on the most challenging representative vesselassociated with the intended clinical use.

ServiceLife and Shelf-Life Verification

Active IVUS devices must undergo service life verification according tothe “Guideline for Registration Review of Service Life of Active MedicalDevices.”

• Cathetersand dedicated accessories must provide shelf-life validation data
• Coating performance testing is recommended for coatedproducts after accelerated or real-time aging studies
• Allcomponents must additionally undergo transport stability testing to confirm productintegrity during distribution

These studies ensure IVUS devices maintainsafety and performance throughout storage and distribution.

Instructions for Use Requirements

The guideline also specifies labeling and documentation requirements forIVUS devices entering the Chinese market.

Instructions for usemust clearly indicate:

• Intended vessel locations
• Applicable vessel diameter ranges

For catheters with lubricious coatings, manufacturers must disclose the primary coating components,coating type, and coating location. The instructions must alsoinclude coating-related warnings and precautions to ensure safe clinical use.

Opportunities and Compliance Challenges for Overseas Manufacturers

The introduction of a dedicated IVUS registration guideline improvesregulatory predictability for companies pursuing China medical device registration for cardiovascular imaging technologies.Defined review standards and clinical evaluation pathways may helpmanufacturers plan regulatory strategies more effectively.

At the same time, the guideline introduces stricter technicaldocumentation and testing requirements that may increase submission complexity.

Key challenges include:

• Expanded documentation requirements for coating materials
• Strict registration unit classification rules
• Animal testing expectations covering specificcoronary vessels
• Clinical data requirements for advanced IVUSfunctions

Manufacturers that fail to address these requirements early mayencounter supplementary data requests or longer NMPA review timelines.

Recommended Actions for IVUS Manufacturers

Foreign manufacturers planning IVUS registration in China should beginevaluating how the guideline affects existing product portfolios and regulatorystrategies.

Recommended stepsinclude:

Conduct a Compliance Gap Analysis Immediately

Evaluate existingproducts against the guideline requirements, particularly regardingregistration unit classification (coronary vs. peripheral, mechanicalrotational vs. phased array), coating study documentation, and animal studydesign. Identify gaps and define corrective measures.

Strengthen Coating Material Studies

For catheters withlubricious coatings, prepare coating integrity data, lubricity performancetesting, and particle shedding quantification according to the dedicatedcoating guideline. Ensure coating composition and warnings are clearly statedin the instructions for use.

Standardize Animal Study Protocols

Coronary IVUS studiesmust cover the right coronary artery, left anterior descending artery, and leftcircumflex artery. Peripheral studies should select the most challengingrepresentative vessels (e.g., aorta or lower-limb vessels). Use a five-point Likertscale and independent blinded evaluation by two reviewers.

Select the Clinical Evaluation PathwayCarefully

Predicate devicecomparison may be used for standard products, but plaque characterizationfunctions and IVUS-based FFR functions require clinical data. Products with newdesigns or significantly different parameters should plan for clinical trials.

Use Pre-submission Consultation and OverseasTesting Policies

Engage with NMPAthrough pre-submission consultations to clarify technical questions andevaluate the use of overseas testing self-inspection policies to ensure testrepresentativeness and reduce the risk of supplementary requests or repeatedtesting.

Implications for IVUS ManufacturersEntering the China Market

While theguideline improves regulatory transparency, it also introduces more granulartechnical and testing expectations for IVUS products. Requirements related to registration unit classification, coating validation, animal studies, andclinical evaluation may require manufacturers to reassess existing developmentand registration strategies.

For companies preparing IVUS submissions inChina, these changes place greater emphasis on early regulatory planning andtechnical alignment. Addressing potential gaps in testing documentation,clinical evidence, or product configuration before submission can significantlyreduce the risk of supplementary requests or extended review timelines.

Navigating these evolving requirementsoften requires specialized regulatory expertise. Through regulatory strategydevelopment, compliance gap analysis, clinical evaluation planning, and fullNMPA registration support, Cisema helps international medical device companiesinterpret new guidance documents and align their submission strategies withChina’s regulatory expectations.

Contact Cisema today to evaluate how thenew IVUS registration review guideline may impact your product registrationstrategy in China.

Further Information

Explore Cisema’s services for China medical device registration, including regulatorystrategy development, compliance gap analysis, clinical evaluation planning,and full NMPA submission support for overseas manufacturers entering theChinese market.

References

“Announcement on the Release of Five Registration ReviewGuidelines Including the Guideline for Registration Review of IntravascularUltrasound Diagnostic Devices (CMDE Announcement No. 12 of 2026)”— Center for Medical Device Evaluation (CMDE), National Medical ProductsAdministration.