In medical device registration consultation, applicants are frequently confused about the classification of ultrasonic devices. With wide applications ranging from diagnosis to therapy, such products are not uniformly classified as Class II or III. Their classification is comprehensively determined per Rules for the Classification of Medical Devices[2] and 2022 Catalogue of Medical Devices based on intended use, mechanism of action, structural composition and potential risks to human body.

Ultrasonic surgical devices are mainly categorized under Subclass 01 Ultrasonic Surgical Devices of Class 01 Active Surgical Instruments. Nevertheless, even among ultrasonic devices, regulatory classification varies significantly:

Professional Advice: For product classification confirmation, priority shall be given to judging whether the device is invasive, directly used for life support or implanted into human body, or equipped with high-risk functions such as vascular sealing. For instance, ultrasonic devices designated for intraoperative vascular sealing are almost uniformly classified as Class III medical devices. For ultrasound-aided diagnostic software, classification depends on the degree of its algorithm's influence on clinical decisions, and high-risk algorithms may even be upgraded to Class III. Wrong classification will cause fundamental deviation of registration documents and possibly force full restart of registration submission during technical review, leading to substantial time and financial losses.

In accordance with NMPA's Technical Guidelines for Clinical Evaluation of Medical Devices[4] and Technical Review Guidelines for Predicate-based Clinical Evaluation of Ultrasonic Soft Tissue Cutting and Hemostasis Systems[1], ultrasonic surgical devices mainly adopt two clinical evaluation options: predicate-based clinical evaluation and clinical trial. The route selection directly affects registration cost, timeline and resource input.

1. Pros and Cons of Predicate-based Evaluation

The core of predicate evaluation is to demonstrate substantial equivalence between the submitted product and legally marketed predicate devices in working principle, configuration, performance parameters, intended use and mechanism of action. The guideline specifies that where impacts of discrepancies between the applicant's product and predicate devices on safety and effectiveness can be verified via non-clinical tests, clinical data for the submitted product is not required[1].

Applicable Prerequisites:

• The product shares high similarity with marketed predicate devices in core technical parameters and intended use.

• Any discrepancies between products can be fully verified and comprehensively justified via non-clinical evidence including standardized in vitro tests (e.g. in vitro burst pressure test), computer simulation, published literature or animal studies.

Submission of Discrepancy Supporting Data:

• Where discrepancies exist between the subject device and predicate device (such as slight modification of blade geometry, optimized raw materials or partial upgrade of software algorithm), sufficient scientific evidence shall be provided to verify such changes will not introduce extra safety hazards or compromise product efficacy. Typical supporting evidence includes:

1. In-vitro burst pressure test: Evaluates instant strength and reliability of vascular closure, especially the sealing performance against blood vessels of varying diameters.

2. Acute animal test: Investigates real-time cutting performance, haemostasis outcome and thermal injury on living tissue.

3. Chronic animal test: Assesses long-term haemostasis effect, tissue healing status and potential delayed adverse reactions.

Special Considerations for High-Risk Devices:

• The relevant guideline specifically specifies that ultrasonic soft tissue cutting and sealing systems claimed to seal vessels of 7mm or larger carry elevated clinical risks and technical complexity. Where non-clinical studies (e.g. animal tests) fail to sufficiently prove safety and effectiveness, regulators may require supplementary verification based on proprietary clinical data of the subject device; accordingly, partial clinical trials may be mandatory even for predicate-equivalent products.

Industry Pain Point Analysis:Data traceability stands as one of the biggest obstacles during predicate-based clinical evaluation. Most applicants struggle to obtain complete original performance test data, detailed structural exploded drawings or core software algorithm flowcharts of selected predicate devices. In absence of such critical equivalence evidence, even minor product differences will lead to repeated supplementary data requests during review, or final transition to time-consuming clinical trials due to insufficient equivalence demonstration.

2. Necessity and Strategy for Clinical Trial Route

Full clinical trials are generally mandatory for products satisfying the following conditions:

Novel working principle: The product adopts innovative ultrasonic technology or functional mechanism unavailable among existing marketed products.

Groundbreaking core algorithm: The core algorithm of ultrasound-aided diagnostic software delivers disruptive innovation and exerts critical impacts on clinical decision-making.

Failed equivalence demonstration: Non-clinical research cannot substantiate equivalence with marketed predicates owing to unavailable predicate data, excessive product discrepancies or substantially escalated risk level.

Expanded indications: The product targets brand-new clinical indications not covered by existing predicate devices.

The Special Review Procedure for Innovative Medical Devices (shortened as Innovative Channel) is a regulatory green channel launched by the state to incentivize medical device R&D and innovation. It enables expedited market access for genuinely innovative products while imposing stricter qualification requirements on applicants. Strategic assessment is essential before submitting ultrasonic surgical devices under this scheme.

Pros of the Innovative Channel: Policy Benefits & First-mover Market Edge

Priority processing: Priority is granted throughout registration submission, technical review and administrative approval to substantially shorten time-to-market.

Early consultation mechanism: Dedicated reviewers are assigned to conduct in-depth technical communications at critical milestones including product finalization and clinical trial protocol formulation to deliver professional guidance and cut compliance risks and blind R&D investment.

Brand premium and market recognition: The Innovative Medical Device certification serves as official endorsement of superior technical performance and clinical value, facilitating brand building, investment attraction and advantageous market promotion.

Fiscal and policy incentives: Multiple local governments provide extra R&D subsidies, tax preferences and procurement support to lower overall development expenses.

Cons of the Innovative Channel: Strict Entry Barriers & Heavy Resource Input

Stringent technical thresholds:

• Domestic pioneering: Core technology is protected by invention patents, manufactured domestically with first-of-its-kind technical solution nationwide.

• Leading technical level: Featuring fundamental improvements versus existing alternatives and ranking at domestic or global leading technical tier.

• Remarkable clinical value: Targeting diagnosis or treatment for rare diseases, malignant tumors, geriatric-specific illnesses and pediatric conditions, or addressing unmet clinical needs with proven prominent clinical benefits.

Constraints on clinical evaluation route:

• As innovative products are domestically pioneering in most cases, no marketed predicate devices are available for comparison. Full clinical trials are practically mandatory to verify product safety and efficacy via adequate clinical datasets.

Substantial capital and timeline pressure: Full clinical trials bring the following burdens:

• No available predicate devices for domestically pioneering innovative products, which necessitates complete clinical trials to validate safety and effectiveness with sufficient clinical evidence.

• High costs for subject recruitment and follow-up management, especially for rare disease or niche indications with difficult patient enrollment.

• Prolonged trial duration spanning years from protocol drafting to data lock-up.

• Unpredictable risks: Innovative devices face more unknown hazards during clinical trials requiring robust risk management capability.

Registration of ultrasonic surgical devices constitutes a systematic project integrating technical R&D, regulatory interpretation and strategic planning. Accurate classification determination, rational selection of clinical evaluation routes and prudent decision on the innovative review channel are critical to shorten registration cycle, control compliance risks and secure commercial success of the product.

As a CRO specialized in active medical device registration, we fully recognize the relevant complexities and challenges. Our professional service scope covers the following items:

Medical device classification and registration route planning: Accurately define product classification and formulate cost-effective registration strategies.

Full-cycle support for predicate-based clinical evaluation: Including predicate device screening, discrepancy report drafting, non-clinical trial protocol design and test data compilation.

Application strategy for innovative medical device review channel: Assess innovation eligibility, compile innovation justification documents and provide end-to-end application guidance.

Non-clinical study protocol design and implementation guidance: Ensure in vitro burst pressure tests, animal studies and other trials comply with regulatory specifications.

Regulatory consultation and registration dossier compilation: Facilitate effective communication with NMPA and prepare high-quality registration documentation.

[1] NMPA. Guideline for Technical Review of Predicate-Based Clinical Evaluation of Ultrasonic Soft Tissue Cutting and Vessel Sealing System, Announcement No.93 of 2021.

[2] NMPA. Rules for Classification of Medical Devices, Announcement No.104 of 2017.

[3] NMPA. Classification Catalogue for Medical Devices (2022 Edition).

[4] NMPA. Guideline for Clinical Evaluation of Medical Devices, Announcement No.73 of 2021.

For customized registration strategy services, please contact our professional team to obtain the Classification Catalogue for Medical Devices and one-on-one advisory service.

This document is compiled based on publicly released NMPA regulatory documents for reference only. Customized registration plans shall be formulated in accordance with specific product attributes and latest regulatory requirements, and proactive communication with competent authorities is recommended at key project stages.