Technical Review Guidelines for Hydrogel Dressing Registration
The purpose of this guideline is to guide the research and development, the registration preparation and technical review of hydrogel dressing
products. This guideline is a general requirement for hydrogel dressing products. Registration applicants shall explain and refine the registration information
according to the characteristics of the specific product. Registration applicants
shall also determine whether the specific content is applicable according to the
characteristics of the specific product. If not, the reasons and corresponding
scientific basis shall be elaborated in detail. This guideline is a guiding document for registration applicants and
reviewers, but it does not include the administrative matters involved in
registration approval, nor is it enforced as a regulation. If other methods can
meet the requirements of relevant regulations, they can also be adopted but
detailed research and verification materials shall be provided. This guideline
shall be used by relevant regulations. This guideline is formulated under the current regulations, standard
system and current cognitive level. With the continuous improvement of
regulations and standards, as well as the continuous development of science
and technology, relevant contents of this guideline will also be adjusted timely. The latest version of the standards, guidelines, documents, etc. listed or
referenced applies to this guideline. I. Scope of Application
Hydrogel Dressing is a kind of dressing based on the theory of wet
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wound healing. According to the different content and application of the
hydrogel matrix, hydrogel dressings can be divided into the thin type and the
ordinary type. Based on its structure, it can be divided into pasting edge type
and pasting edge type. According to the requirements of its special use site, there are sacrococcygeal and other special shape products. Hydrogel dressings are generally an adhesive (hydrogel layer) sheet
dressings made by mixing water-soluble polymer particles (such as
carboxymethyl cellulose, pectin, etc.) with rubber and other viscous
substances, which has the absorption property of water-soluble polymer and
adhesive property of rubber. If the outer layer is covered with a coated layer, it
is normally materials like polyurethane layer, polyurethane or polyurethane
covering polyurethane layer; If there is a protective layer, it is generally
normally materials like anti-adhesive paper. This guideline is applicable to sheet hydrogel dressings that conform to
the definition of medical devices, use hydrogel as the main material in the
structure composition, apply to body surface wounds, and serve as the
management of Class III medical devices. This guideline does not apply to other forms of hydrogel products (such
as hydrogel pastes, hydrogel pastes, hydrogel powders, hydrogel gels, hydrogel gauze, hydrogel dressings mixed with other materials, etc.). For
hydrogel dressings containing active ingredients or releasing active
substances/energy, materials of human/animal origin, tissue engineering
materials, degradable materials, etc., the requirements of other relevant
standards or guidelines shall also be followed. If necessary, the definition of
the attributes of the applied products will not be repeated in this guideline.
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II. Division of Registration Units
Products with different main components or ratios shall be divided into
different registration units; Products with different management categories
shall be divided into different registration units. III. Requirements for Registration Application Materials
(I) Summary
- Overview
Describe the management category, classification code and name
determination basis of the declared products. 2. Product Description
The product description shall be comprehensive and detailed. It shall
include at least the product name, material, structure, properties and the
corresponding graphic, mechanism, composition and composition, the
function of each component in the product, the sterilization method, technical
performance indicators, using methods, applicable parts, intended use, etc. of
the declared products. It shall also determine whether the products in the
application scope of this guideline. 3. Specifications and Models
Explain the specifications and models of the products and the basis of
division. The differences between the specifications and models shall be
clarified as well. A comparison table can be used to describe the structure
composition, performance indicators and size of different specifications and
models. 4. Packaging Description
The Summary shall include relevant product packaging description and
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shall indicate primary packaging information appropriate to the sterilization
method. 5. Scope of Application and Contraindications
Registration applicants may further confirm the specific scope of
application and contraindications of the declared products according to the
specific intended use and research data of the declared products and referring
to the relevant requirements of this guideline. 6. Comparison with Listing Products
Registration applicants shall review the domestic and foreign research
and clinical use status and development trends of the predicate/similar
products. Describe the similarities and differences between the declared
product and the predicate/similar products on the market. It is recommended
to express it in a table. The comparative projects are suggested to include the
product name, structural composition, applicable parts, intended use, product
design, raw materials, production process, sterilization method, performance
Indicators, expiration date, listed countries, etc. The listed products shall
comply with the defined scope of this guideline and may include the listing
hydrogel dressings of the applied company or other companies. (II) Research Data
It shall include at least the following: - Raw Material Control
Explain the selection basis of raw materials and clarify the starting
material of the product. At the same time, the chemical name, supplier name, trade name/material code, CAS number, chemical structural
formula/molecular formula, purity, molecular weight and molecular weight
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distribution (if applicable) of all materials (including processing aids, etc.)
required from the starting material to the final product in the production
process shall be listed. Raw materials shall have a stable supply channel to
ensure product quality. Qualification certificates and outsourcing agreements
of raw material manufacturers, quality control standards and inspection reports
(including bills of materials and purchase inspection reports) of raw materials
used must be provided. Registration applicants shall submit relevant information to explain the
safety and efficacy of each component, such as material safety data sheet, relevant toxicological data, clinical application history and other supporting
data.For new materials first used in medical devices, relevant research data
regarding the intended purpose of the product shall be provided. Clarify the usage amount/feeding ratio of each component, the role and
the proportion of each component in the final product, which are suggested to
be provided in the form of a table. For the additives (such as tackifier, plasticizer, softener, Antioxidants, toners and other ingredients), accessory
ingredients, etc. used in the production process, additives, etc. the initial
dosage or concentration, additives or unexpected/unanticipated substance
removal measures and control standards for residual amounts shall be
indicated. Explain the basis of the raw material ratio. Different formulas may
affect the basic properties of hydrogel dressings, such as viscosity, flexibility, breathability, water absorption and integrity after water absorption. It is
recommended to provide corresponding research data. 2. Product Performance Research
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The product performance research data shall be provided. It shall not
only include the basis for determining the efficacy and safety indicators and
other indicators related to quality control, but also the standards or methods
adopted, and reasons and theoretical basis for adopting. The technical indexes
and inspection methods for the products shall be formulated according to the
performance characteristics of the products and the basis shall be explained. 3. Biocompatibility Evaluation Study
Biocompatibility evaluation data shall include:
(1) The basis, projects and methods of biocompatibility evaluation;
(2) Description of the product materials and the product nature of human
body contact;
(3) Reasons and arguments for carrying out or exempting biological tests;
(4) Evaluation of existing data or test results. Biological evaluation or test shall be conducted under the series standards
of GB/T 16886 Biological Evaluation of Medical Devices, and the cumulative
exposure time of products shall be considered in the selection of evaluation
items.4. Sterilization Process Study
Regarding GB 18280.1 Sterilization of health care
products–Radiation—Part 1: Requirements for development, validation and
routine control of a sterilization process for medical devices and other relevant
regulations, the basis for the product packaging and sterilization method
selection shall be submitted. After validation and routine control, the
following validation shall be carried out:
(1) The adaptability of product and sterilization process: The influence of
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sterilization process on hydrogel dressings shall be investigated;
(2) The adaptability of packaging and a sterilization process;
(3) Sterilization process (methods and parameters) and sterility assurance
level (SAL) shall be clarified and sterilization validation report shall be
provided. The sterility assurance level (SAL) shall be no higher than 1×10
-6
;
(4) Residual toxicity: If the method used for sterilization is prone to the
residue, the residue information, control standards and treatment methods shall
be clarified, and research data
