Draft for comments on "Key Points of Technical Review for the Registration of Class II Medical Device Dressing Products in Hunan Province"

In order to guide the registrants in our province to develop, verify and register the second-class medical device dressing products, unify the review scale, and improve the quality and efficiency of the registration review, our center organized and drafted the "Hunan Province Second-class Medical Device Dressing Products". Key Points of Registration Technology Review (Draft for Comment)", which is now open for comments.

If you have any comments or suggestions, please download and fill in the feedback form (Appendix 2), and send the feedback to our center by email (E-mail: 329445126@qq.com) before March 31, 2022.

Appendix:

1. Main Points of Technical Review for the Registration of Class II Medical Device Dressing Products in Hunan Province (Draft for Comment) (Download)

2. Feedback suggestion form (download)

Attachment1

"Key Points of Technical Review for the Registration of Class II Medical Device Dressing Products in Hunan Province (Draft for Comment)"

1. Regulatory information

1. Classification principle

Applicants should submit products as the basis for the management of Class II medical devices (such as classification catalogues, classification definition documents). The same variety that has been listed is not used as the basis for category determination.

1.1 Wound dressing

Class I: 14-10-02 Band-Aid.2; 14-10-08 Liquid, Paste Dressing.3

Class II: None of the ingredients contained in it have pharmacological, immunological or metabolic effects and cannot be absorbed by the human body, and are used for non-chronic wounds (such as superficial wounds, post-operative suture wounds, mechanical wounds, small wounds, abrasions, Nursing care of incision wounds, puncture sites of puncture instruments, first-degree or superficial II-degree burn wounds, infant navel incisions, laser/photon/fruit acid peeling/microplastic surgery wounds) to provide a microenvironment for wound healing . It can also be used to care for the puncture site of a puncture instrument (such as a catheter) and to fix the puncture instrument. Supplied sterile.

Class III: Anti-adhesion to tissues or organs, or as artificial skin; for chronic wounds (ulcers, pressure ulcers, bedsores, deep second- or third-degree burns); or fully or partially absorbed by the body.

1.2 Gynecological gel

Not regulated as a medical device:

It is used for the treatment and prevention of bacterial vaginosis through the antibacterial effect of the contained ingredients;

Or by changing the pH of the vaginal environment, it is used to treat and prevent bacterial vaginosis;

Class II:

By forming a protective film on the vaginal wall, the vaginal wall is physically isolated from external bacteria, thereby preventing the colonization of pathogenic bacteria. Or reduce the concentration of bacteria through the physisorption of substances (charge adsorption). For the prevention of vaginitis. And the product does not contain antibacterial ingredients.

example:

Medical Gel Dressing: Gel made from hydroxyethyl cellulose, propylene glycol, purified water. Supplied sterile. By forming a barrier on the damaged part of the skin; at the same time, it can keep the wound in a certain wet state, and it is used for the care of superficial wounds and wounds after microplastic surgery.

It does not contain pharmaceutical ingredients, acts as a physical barrier (device), and is provided aseptically for superficial wounds and wounds after microplastic surgery. In accordance with Class II medical device management.

Anti-HPV gynecological gel dressing: It is composed of biological protein gel and gel administration device. The biological protein gel consists of hydroxyethyl cellulose (excipient), biological functional protein, glycerol, and purified water. For reducing local HPV load.

Through the physical adsorption of substances, a protective gel film is formed on the vaginal wall to physically isolate the vaginal wall from external bacteria, thereby preventing the colonization of pathogenic bacteria. In accordance with Class II medical device management.

2. Product name

Generic names and their basis for determination: No models, specifications, graphics, symbols, assertions of efficacy, exaggerated efficacy, misleading, unproven conceptual names.

3. Model Specifications

Explain the specifications and models of the products and the basis for their division, and clarify the differences between the specifications and models; comparison tables, pictures (with explanatory text), charts, and structural composition (or configuration), functions, product features, and performance indicators of various models and specifications etc. are described.

For example: the model specification of the applicator product should be specific to the size or weight, not only a certain parameter range.

4. Structural composition

All components, packaging containers (materials), and sterilization methods of the product should be clearly defined, and the vague words "main" and "etc." should not be used. The names of the parts in the structural composition should be standardized. The structure and composition of each document should be consistent, and the sequence of product part numbers should be consistent. The ingredients added to Class II dressings should meet the requirements of not exerting pharmacological, immunological or metabolic effects, and not being absorbed by the human body.

Evidence that ingredients are not absorbed by the body may provide:

① Published documentary evidence

② FDA inactive ingredient list

③ Catalogue of Pharmacopoeia Excipients

④ Others (International Standard Database)

⑤ Transdermal absorption test report (scientifically design the experimental plan according to the clinical use of the product, such as: the product used for the wound surface should be subjected to the transdermal test of the wound surface)

⑥ When there is no transdermal absorption data, the absorption rate is calculated as 100%; if some of the following conditions are met (objective evidence is required): molecular weight > 500 Daltons, highly ionized, and the fat-water partition coefficient Log Pow≤-1 or ≥4 , topological polar surface area>120Å2, melting point>200℃, absorption rate is 10%; if chemically synthesized by one or more structural units, linked by covalent bonds, the average relative molecular mass is greater than 1000 Daltons, And the content of oligomers with a relative molecular mass of less than 1000 Daltons is less than 10%, and polymers with stable structure and properties (except raw materials with high biological activity) may not be considered for transdermal absorption. (such as protein ingredients)

⑦ The classification catalog and classification definition document clarify the structure and composition of Class II products.

Common ingredients: carboxymethyl cellulose, hydroxyethyl cellulose, isomaltose oligosaccharide, pectin, gelatin, polyethylene glycol, sodium alginate, trehalose, carbomer, β-glucan, Pharmacopoeia Chinese medicinal excipients (such as emulsifiers, stabilizers, thickeners, suspending agents, flavoring agents, pH adjusters, humectants), protein polypeptides (such as: type III recombinant collagen, anhydrous bovine β-lactoglobulin)

Prohibited ingredients: disinfection, antibacterial drugs, chemical drugs, traditional Chinese medicines, ceramides.

Essential oils, plant extracts, chitosan and biological products should provide evidence that they do not exert pharmacological, immunological or metabolic effects and are not absorbed by the human body.

Pharmaceutical excipients do not play an active role in the human body (such as metabolism, antibacterial, oxidation, etc.) under a certain dose, but only play an auxiliary role (such as pH adjustment, antiseptic, etc.), and can be added in limited quantities.

2. Summary information

1. Scope of application

1.1 Wound dressing: used for non-chronic wounds (such as superficial wounds, post-operative suture wounds, mechanical wounds, small wounds, abrasions, incision wounds, puncture sites of puncture instruments, and first- or superficial-II burns and scald wounds , baby navel incision, laser/photon/fruit acid peeling/microplastic surgery) care to provide a microenvironment for wound healing. It can also be used to care for the puncture site of a puncture instrument (such as a catheter) and to fix the puncture instrument.

1.2 Gynecological gel: used to reduce HPV viral load. By forming a protective gel film on the vaginal wall, it physically isolates the vaginal wall from external bacteria, thereby preventing the colonization of pathogenic microorganisms.

example:

If the scope of application of wound dressings is: "improve flushing and swelling"; if the scope of application of gynecological dressings is: to reduce vaginitis reaction, improve vaginal environment, and improve symptoms of vulvovaginal congestion and swelling caused by gynecology, the corresponding mechanism of action and clinical Test Data.

Note: Definition of chronic wound:

(1) Diabetic ulcers, such as diabetic foot;

(2) Radiotherapy wounds of cancer patients;

(3) Vascular ulcer;

(4) Infectious ulcers, pressure ulcers, etc.

2. Registration unit division

The division of registration units should refer to the "Guidelines for the Division of Medical Device Registration Units", and in principle, the characteristics, structural composition, performance indicators and scope of application of the product are used as the basis for division.

When product performance indicators are different due to different sterilization methods, in principle, they are divided into different registration units.

Due to the different scope of application, in principle, it is divided into different registration units.

example:

1. Catheter fixation stickers and wound dressings should be divided into different registration units.

2. Recombinant collagen skin repairing film: the solution is made from recombinant collagen, glycerin, carbomer, triethanolamine, phenoxyethanol and purified water, or the solution is freeze-dried into powder. The base material can be combined, and the powder can be prepared with purified water. Products are supplied sterile and non-sterile.

Model Specifications: Type I: It is composed of recombinant collagen solution and plant fiber non-woven fabric.

Type I D: It is made by freeze-drying of recombinant collagen solution and plant fiber non-woven fabric.

Type II: It is composed of recombinant collagen solution and silk non-woven fabric.

Type II D: Freeze-dried from recombinant collagen solution and silk non-woven fabric.

Type III: It is composed of recombinant collagen solution and nano-microcrystalline non-woven fabric.

Type III D: Freeze-dried from recombinant collagen solution and nano-microcrystalline non-woven fabric.

Type IV consists of recombinant collagen solution and polyethylene plastic bottle (tube)/spray can.

Type IV D: Consists of recombinant collagen lyophilized powder and polyethylene plastic bottle/glass bottle

The product structure, composition and scope of application are the same, and the forms are divided into solution and freeze-dried types. In the technical requirements, only the sterilization performance is different, and the others are the same, and can be divided into the same registration unit.

3. Non-clinical data

1. Product technical requirements

1.1 Performance indicators

The formulation of product technical requirements shall comply with the requirements of the Guidelines for Compilation of Technical Requirements for Medical Device Products. The technical requirements and inspection methods for product safety, effectiveness and controllable quality should be determined according to the technical characteristics and clinical use of the product. The technical indicators should not be lower than the relevant national standards or industry standards, and the test methods in the product technical requirements should be verified methods. If the test method in the standard is modified, the content and reason for modification shall be explained, and the verification data shall be submitted.

Basic requirements (not limited to):

(1) pH

(2) Heavy metals

(3) Content and identification of main components

(4) Liquid absorption (if applicable)

(5) Liquid absorption capacity (if applicable)

(6) Water vapor transmission rate (if applicable)

(7) Water resistance (if applicable)

(8) Sticky (if applicable)

(9) Peel strength (if applicable)

(10) Residual amount of ethylene oxide (if any)

(11) Bacteriostatic properties (if any)

(12) Sterility/Microbial Limit (if any)

(13) Film-forming properties (if any)

(14) The performance of the packaging container, such as spray performance (if any)

(15) Bacterial endotoxin in aseptic supply of protein or polypeptide products

Raw material suppliers, quality requirements (such as molecular weight) are provided in the technical requirements appendix

Example: The content of main components/identification performance indicators (such as protein content) should be set

1.2 Inspection method: national standard or industry standard, other

YY/T1627-2018 General requirements for dressings and band-aids for acute wounds

YY/T 1293.2-2016 Contact wound dressings-Part 2: Polyurethane foam dressings

YY/T 1293.4-2016 Contact wound dressings-Part 4: Hydrocolloid dressings

YY/T 1293.5-2017 Contact wound dressings-Part 5: Alginate dressings

YY/T 1293.6-2020 Contact wound dressings-Part 6: Mussel mucin dressings

YY/T 0148-2006 General requirements for medical tapes

YY/T 0471.1-2004 Test methods for contact wound dressings - Part 1: Liquid absorbency

YY/T 0471.2-2004 Test methods for contact wound dressings - Part 2: Water vapor transmission rate of breathable film dressings

YY/T 0471.3-2004 Test methods for contact wound dressings-Part 3: Water resistance

YY/T 0471.4-2004 Test methods for contact wound dressings-Part 4: Comfort

YY/T 0471.5-2017 Test methods for contact wound dressings-Part 6: Bacteriostatic properties

Guidelines for Technical Review of Registration of Polyurethane Foam Dressing Products (2017 No. 44)

The above-mentioned standards include those often involved in product technical requirements. The applicant should cite the applicable standards in the above standards according to the characteristics of the product, and can also cite other standards when there are special needs.

If there is a new version of national standards and industry standards released and implemented, the requirements of product performance indicators should implement the latest version of the national standards and industry standards.

1.3 Inspection report:

Typicality (whether the products submitted for inspection can represent all the specifications and models in this registration unit, and if they cannot be covered, difference detection should be carried out)

Integrity (whether the product submitted for inspection is subject to full performance inspection in accordance with the specific items in the product technical requirements, whether there is any missing or undetectable situation, and whether there is any reason to submit inspection reports issued by multiple inspection agencies)

Consistency (whether the product information submitted for inspection is consistent with other materials, and whether the product performance indicators in the report are consistent with the technical requirements provided)

The inspection scope of the inspection center (whether the inspection items are in the inspection scope of the inspection center; for the self-inspection report, the enterprise should clarify whether it has the corresponding self-inspection ability)

2. Biological evaluation

In accordance with the requirements of GB/T 16886.1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management" and "Notice on Printing and Distributing Biological Evaluation and Review Guidelines for Medical Devices" For compatibility evaluation, the data should include:

a. Basis, items and methods of biocompatibility evaluation.

b. Description of materials used in the product and nature of human contact.

c. Justification and justification for conducting or waiving biological testing.

d. Evaluation of existing data or test results.

If biological tests are carried out for evaluation, the exposure time of cumulative use of the product should be considered in the selection of test items, and at least biological evaluation studies on cytotoxicity, irritation or intradermal reaction, and delayed type hypersensitivity should be carried out.

a. For products with different packaging materials, if the packaging material compatibility test has been done and the regulations are met, only the biological test of the content can be done; if the packaging material has a pharmaceutical packaging certificate, only the biological test of the content can be done ; For products with different packaging materials, by analyzing whether there is a chemical reaction between the packaging material and the product components, select the packaging material that is most likely to precipitate chemical substances, and do an overall biological test.

b. If the scope of application is male and female reproductive organs, two mucosal irritation tests are required for biocompatibility evaluation.

c. For dressings used in infant navels, juvenile animals should be selected for biological evaluation.

d. For products used in the nasal vestibule, considering the possibility of contact with the nasal mucosa, a nasal mucosa test should be performed.

e. For dressings around the eyes, an eye irritation test should be done.

If the biocompatibility evaluation is carried out by comparing the equivalence between the declared product and the commercially available product, the evaluation shall be carried out in accordance with the requirements of the "Notice on Printing and Distributing Biological Evaluation and Review Guidelines for Medical Devices", and data shall be provided to prove that the declared product is compatible with the marketed product. Products are equivalent. The following considerations are required:

a. The applicant needs to confirm the chemical composition of the materials, the proportion of each constituent material, the physical structure of the product, the surface characteristics, the production process, the sterilization method, and the raw material supplier between the tested similar products in the test report and the declared products.

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