The most frequent mistake for liquid dressing projects lies in oversimplified product definition at R&D initiation rather than missing individual registration documents during submission. Regulatory authorities determine product classification not based on liquid form alone, but intended use, mechanism of action, ingredient properties and risk level. Claims exceeding superficial wound care and physical barrier protection or formulations with therapeutic ingredients will result in altered registration pathways.
Products with antimicrobial ingredients and corresponding antibacterial claims or pharmaceutical components with therapeutic indications face stricter review criteria and deviate from the original Class II registration plan. Many projects fail not due to manufacturing difficulties but overstated functional claims that trigger complicated review requirements.
Three assessments are recommended at the classification stage:
① Accurate indication definition: limited to superficial wound care, skin protection and physical barrier formation only;
② Clarified ingredient features: core ingredients merely exert physical effects without pharmacological, metabolic or immunological risks;
③ Documented classification rationale: boundary assessment recorded with reference to classification catalogue, relevant guidelines and official announcements.
Many registrants assume liquid dressings feature simple composition and qualify for clinical trial exemption. However, regulatory compliance hinges on adequate supporting evidence instead of arbitrary exemption. Per the Technical Guidelines for Clinical Evaluation of Medical Devices, the predicate evaluation pathway is applicable only when the investigational product is fully comparable with the predicate device in intended use, technical specifications and biological properties.
This constitutes the second common pitfall in liquid dressing registration: treating predicate evaluation as a task requiring merely a competitor's instructions for use. Claims such as wound healing promotion, anti-inflammation and bacteriostatic therapy beyond physical barrier function, or unverified discrepancies in core ingredients, performance parameters and working principles will necessitate additional supplementary evidence and disqualify the predicate route.
Three core assessments shall be completed prior to confirming the clinical evaluation pathway:
① Validation of predicate eligibility: genuine comparability between test and reference products;
② Completeness of discrepancy evidence: verified variances in ingredients, performances and intended indications;
③ Precise and verifiable IFU wording: all functional claims backed by solid test data.
Late-stage registration setbacks seemingly arising from document defects are mostly rooted in inadequate quality management system. Despite lower complexity compared with high-risk implantable devices, liquid dressings undergo linked inspections covering formulation composition, raw material sourcing, production process control, microbial risk management as well as consistency between labeling specifications and product performance throughout technical review and on-site QMS audit.
Two prevalent non-compliance issues exist: raw material management relying solely on supplier certificates, and disjointed documentation among R&D archives, test specifications, process records and registration dossiers. The former fails to justify batch-to-batch consistency and core performance indicators, while the latter creates inconsistency between well-prepared documents and actual on-site implementation during review or inspection.
Against tightened regulatory oversight, quality system construction shall no longer be treated as a follow-up task post-registration. The revised Good Manufacturing Practice for Medical Devices issued by NMPA will take effect on November 1, 2026. Enterprises in registration preparation and system optimization shall integrate logical coherence of R&D, production, testing and registration documents in advance.
01 | Confirm product classification and intended scope to avoid wrong orientation at project initiation |
02 | Sort out predicate devices and clinical evaluation routes in parallel, and check eligibility for clinical trial exemption in advance |
03 | Formulate testing and verification schemes targeting core performance indicators and potential risks |
04 | Accumulate QMS documents synchronously during R&D to ensure consistency between documents and actual operations |
05 | Complete consistency review of registration documents, manufacturing processes, raw materials and IFU prior to formal submission |
The core competitive edge in medical liquid dressing registration lies in accurate upfront planning instead of rapid dossier drafting. Incorrect classification leads to deviated project orientation; improper clinical evaluation route triggers uncontrolled cost and timeline; incomplete quality system evidence may result in project failure during on-site inspection.
Speedy registration is achievable for registrants, yet blind pursuit of progress shall be avoided under ambiguous product definition, insufficient supporting evidence and immature quality system. Addressing core compliance issues in advance delivers far greater benefits than passive revision upon official supplementary notice.
Deda Medical provides full-spectrum services for liquid dressing projects, including classification consultation, registration submission, predicate-based clinical evaluation support, QMS setup and pre-audit coaching, standardizing compliance roadmap and development schedule from project initiation.
Consult our professional team for customized solutions if you are developing liquid dressings, wound dressings or other medical dressing products.
This article is compiled based on official NMPA regulatory documents for reference only. Final registration schemes shall be formulated in accordance with specific product attributes and latest regulatory requirements, and proactive communication with regulatory authorities is recommended at critical project phases.
[1] NMPA Announcement on Partial Revision of the Classification Catalogue for Medical Devices (No.30 of 2022) together with Revision Instructions for Class I Medical Devices Catalogue. Original Document Link
[2] CMDE Guidance for Technical Review of Liquid Dressing Registration. Original Document Link
[3] NMPA Announcement on Issuing Five Technical Guidelines Including the Guideline for Clinical Evaluation of Medical Devices (No.73 of 2021). Original Document Link
[4] Catalogue of Medical Devices Exempted from Clinical Evaluation (2025 Version), issued by NMPA. Original Document Link
[5] NMPA Announcement on Regulatory Classification of Medical Sodium Hyaluronate Products (No.103 of 2022). Original Document Link
[6] NMPA Announcement on Issuing Good Manufacturing Practice for Medical Devices (2025). Original Document Link
Note: This content is for official platform release only. Specific registration strategies shall be formulated based on product composition, intended use and latest regulatory review requirements.
