Analysis on key points for registration of hyaluronic acid gel dressings：_Medical Devices_Professional Fields

Analysis on key points for registration of hyaluronic acid gel dressings：

Classification judgment, exemption scope of clinical evaluation and advance layout of quality system

For hyaluronic acid gel dressing projects, registration efficiency depends not on the final submission dossier, but on accurate core judgments in the initial R&D stage: whether the product is classified as Class II or Class III medical device, qualification basis for clinical evaluation exemption, and whether the quality system can support subsequent testing and inspection. As NMPA continuously clarifies classification rules, clinical exemption catalog and GMP requirements for medical sodium hyaluronate products, enterprises need to integrate R&D, registration and quality system construction under unified compliance logic.

Introduction

For sodium hyaluronate gel dressing projects, registration efficiency is rarely determined by the final registration dossier, but by accurate key judgments in the early project initiation stage: whether the product is regulated as Class II or Class III medical device, eligibility for clinical evaluation exemption, and whether the quality management system can support subsequent testing and on-site inspections. As NMPA keeps clarifying classification rules, clinical exemption catalogue and manufacturing quality control requirements for medical sodium hyaluronate products, enterprises shall align R&D, registration and quality system development under a unified compliance framework.

Core Reminders
Product classification shall be confirmed prior to dossier preparation; wrong classification will lead to improper testing and evaluation strategies afterward. Exemption from clinical evaluation does not mean loose requirements; complete comparative data supporting regulatory review is still mandatory. For ongoing projects around 2026, advance quality system development to prevent rework during registration testing and on-site QMS inspection.

Core Reminders

Product classification shall be confirmed prior to dossier preparation; wrong classification will lead to improper testing and evaluation strategies afterward.

Exemption from clinical evaluation does not mean loose requirements; complete comparative data supporting regulatory review is still mandatory.

For ongoing projects around 2026, advance quality system development to prevent rework during registration testing and on-site QMS inspection.

Clarify The Three Core Registration Judgment Points First

Judgment Items	Questions to Be Addressed by Manufacturers	Impacts on Registration Progress
Product Classification	Is the product absorbable by human body? Is it intended for chronic or non-chronic wounds? Does its functional scope fall within medical dressing definition?	Determines Class II or Class III administration, and directly influences test scheme, submission schedule and cost input.
Clinical Evaluation Route	Does the product comply with applicable scope specified in Catalogue of Devices Exempt from Clinical Evaluation and relevant guidance documents?	Decides whether registration can be supported by predicate comparison and clinical evaluation data or supplementary clinical evidence is required.
QMS Preparation Status	Are documents regarding raw material control, process records, sterilization and stability testing properly archived synchronously?	Determines smooth progress of registration testing and QMS on-site audit and avoids concentrated supplementary documentation in later phase.

Classification Confirmation Is the Starting Point Rather Than a Procedural Formality

In the registration of sodium hyaluronate gel dressings, a prevalent deviation is presetting a fixed registration route merely based on sodium hyaluronate content. In fact, NMPA Announcement No.103 of 2022 has specified clear classification criteria for medical sodium hyaluronate products: when used as medical dressings, products that are partially or fully absorbable by human body or indicated for chronic wounds are categorized as Class III medical devices; non-absorbable products intended for non-chronic wounds fall under Class II medical devices.

Accordingly, manufacturers shall define core parameters including absorbability, wound type, intended use and mechanism of action at project kickoff instead of judging classification only by raw material name. Misclassification will lead to deviations in subsequent testing schemes, clinical evaluation design and dossier preparation, possibly triggering rework and unnecessary early-stage investment losses during technical review.

Common Misconceptions

Conducting R&D and dossier preparation per past experience first, with classification confirmed only prior to testing or technical review. For sodium hyaluronate gel dressings, such workflow tends to expose fundamental directional flaws at the latest project phase.

Eligibility for Clinical Exemption Depends on Catalogue Definition Instead of Product Name

Many developers assume all gel dressings qualify for clinical evaluation exemption, yet regulators make rulings based on compliance with official catalogue and guideline criteria rather than product denomination. As stipulated in the 2025 Catalogue of Medical Devices Exempted from Clinical Evaluation, standard gel dressings consist of gelling agents and water with optional buffer salts; all components are non-absorbable and pharmacologically inactive, supplied sterile for absorbing wound exudate or transferring moisture away from wound surfaces.

Therefore, restrained wording is essential for the intended use and product description of sodium hyaluronate gel dressings. Claims such as wound healing acceleration, anti-inflammatory repair exceeding physical efficacy scope or addition of pharmacologically active ingredients will disqualify products from the conventional review pathway for common gel dressings. Clinical exemption is not an automatic shortcut but a compliant option premised on matching catalogue definition, clarified action mechanism and complete supporting evidence.

Core Review Focus: Intended Use, Product Comparison and Critical Performance Evidence

Even with qualification for clinical evaluation exemption, dossier compilation cannot be done by simple document assembly. For the registration of sodium hyaluronate gel dressings, reviewers mainly examine whether the product comparison forms complete evidence chain, discrepancies are reasonably justified and critical performances are fully verified.

Enterprises shall compile submission documents in accordance with the Technical Guidelines for Clinical Evaluation of Medical Devices, Technical Guidelines for Comparative Documentation of Products in the Catalogue of Medical Devices Exempted from Clinical Evaluation and corresponding registration review guidelines. The primary difficulty lies not in the availability of predicate products, but the rational selection of comparators and regulatory acceptance of differences in composition, intended use, structural features and performance parameters between the submitted product and predicate device.

In practice, supplementary information requests are mostly triggered by over-broad intended-use claims, ambiguous description of technical characteristics and insufficient supporting data for performance comparison. Deficiencies in the above fundamentals will lead to lengthy supplementary work even under the clinical exemption pathway.

Advance Quality System Establishment for Projects Launched in 2026

Manufacturers developing sodium hyaluronate gel dressings should no longer postpone quality system construction till the late registration phase. NMPA released the revised Good Manufacturing Practice for Medical Devices in 2025, which shall take effect on November 1, 2026. Accordingly, companies need to sort out fundamental evidence covering raw material control, critical process records, sterile management, sample retention and stability testing while conducting R&D and registration simultaneously.

For sodium hyaluronate gel products, raw material origin, molecular properties, impurity control, batch consistency and process stability will be closely scrutinized during registration testing and on-site QMS inspection. Apart from incomplete documents, enterprises shall prioritize preventing inconsistency between filed documents and actual production, missing records and untraceable core test data.

Recommendations from Deda Medical: Complete Three Preliminary Steps Prior to Formal Registration Submission

Conduct preliminary classification prediction. Confirm Class II or Class III development route based on absorbability, wound type, intended use and working mechanism.

Evaluate clinical trial exemption feasibility in advance. Check against exemption catalogue, comparison requirements and relevant guidelines to confirm eligibility for predicate comparison-based clinical evaluation route.

Build quality system and technical documents simultaneously. Avoid centralized document supplementation prior to registration testing or QMS inspection; archive R&D records, raw material control documents and critical process files throughout development.

Conclusion

The core of sodium hyaluronate gel dressing registration lies in well-defined classification judgment, clarified clinical exemption scope and complete quality system evidence rather than voluminous registration dossiers. Deda Medical delivers customized registration strategies tailored to product specifics for clients aiming to streamline NMPA registration progress, optimize predicate-based clinical evaluation and synchronize formulation of product technical requirements with quality system construction.

Our professional team provides one-on-one consultation and access to the Catalogue of Medical Device Classification upon inquiry for bespoke registration solutions.

This article is compiled based on official regulatory documents released by NMPA for reference only. Final registration plans shall be formulated in line with product attributes and latest regulatory provisions, and proactive communication with regulatory authorities is recommended at key project milestones.

Reference Basis

• NMPA Announcement on Regulatory Classification of Medical Sodium Hyaluronate Products (No.103 of 2022).

• Policy Interpretation for Announcement on Regulatory Classification of Medical Sodium Hyaluronate Products (No.103 of 2022).

• Catalogue of Medical Devices Exempted from Clinical Evaluation (2025 Version).

• Guideline for Clinical Evaluation of Medical Devices (Issued with NMPA Announcement No.73 of 2021).

• Technical Guideline for Comparative Statement of Products Included in the Catalogue of Medical Devices Exempted from Clinical Evaluation (Attached to Announcement No.73 of 2021).

• Guidance for Technical Review of Hydrogel Dressing Registration (No.22 of 2023).

• Guidance for Technical Review of Medical Sodium Hyaluronate Wound Dressing Registration (No.21 of 2024).

• NMPA Announcement on Issuing Good Manufacturing Practice for Medical Devices (No.107 of 2025).