Preamble

The purpose of this guideline is to guide the registration applicant to prepare and write the registration declaration of dialysate filters (hereinafter referred to as filters), and also to provide reference for the technical review department.

This guideline is a general requirement for filters, the applicant should determine whether the content is applicable according to the specific characteristics of the product. If it is not applicable, it is necessary to specify the reasons and the corresponding scientific basis, and based on the specific characteristics of the registration declaration information to enrich and refine the content.

This guideline applies to the filter products in line with the provisions of the industry standard YY/T 1272 ‘dialysate filter’. This guideline is formulated under the current regulations and standard system and the current cognitive level, with the continuous improvement of regulations and standards, as well as the continuous development of science and technology, the relevant content will be adjusted in due course.

Scope of application

This guideline applies to the filter for passive medical devices. Filters use the filtration effect of hollow fibre membrane, a single filter supporting the use of haemodialysis equipment, filtration and removal of endotoxin, bacteria and insoluble particles in the dialysis fluid, used to prepare ultrapure dialysis fluid. The filters do not contain haematological products (e.g. haemodialysis lines, haemodialysis catheters, arteriovenous fistula needles, etc.) for haemodialysis and other treatments, as well as active medical devices. Common structures of filters include protective caps, end caps, seals, sealants, hollow fibre membranes, and housings. They are usually supplied in a sterile, pyrogen-free state and are used individually to filter haemodialysis fluid, sterilised according to the manufacturer's requirements, and used no more often and/or for no longer than the manufacturer's specifications.

Key points for registration review

The name of the filter product should be in accordance with the ‘Rules for the Naming of Common Names for Medical Devices’, ‘Guidelines for the Naming of Common Names for Blood Transfusion, Dialysis and Extracorporeal Circulation Devices’, etc., describing the common name of the declared product and the basis for its determination. Usually do not use ‘polyethersulfone’, ‘polysulfone’ and other words.

Describe the scope of application. Specify the maximum number of uses and/or the longest use time, filtration rate, filtration performance and other information in the product parameters. Filters are managed in accordance with Class III medical devices and belong to blood purification aids under 10-04-03 in the Catalogue of Medical Devices Classification. Includes documentation such as product listings, records of previous communications (if applicable), master file authorisation letters (if applicable) and declarations of conformity.

Product Description

Describe the working principle, mechanism of action (if applicable), structure and composition, raw materials of each component (if the filter contains biological materials or derivatives, describe the source of the substance and raw materials, the intended purpose of use, the main mode of action; if the filter contains an active pharmaceutical ingredient or drug, describe the name of the drug, the intended purpose of use, the main mode of action, the source), the state of delivery and sterilisation (if applicable). Provide a schematic structure and/or product illustration, the method of use and illustration (if applicable), as well as the characteristics that distinguish it from other similar products. If necessary, provide illustrations.

Model specifications: For filters with multiple model specifications, the difference between each model specification should be made clear. Use a comparison table or pictures and charts with explanatory texts to describe the structural composition, functions, product features and technical parameters of various models and specifications.

Packaging description: Provide information related to the packaging of the filter, in particular, information and data on its sterile barrier system (including the initial packaging compatible with the sterilisation method, if applicable) should be carefully described.

Development history: describe the background and purpose of the filter's development. If there is a reference to a comparable or predecessor product, information on the comparable or predecessor product should be provided and the reasons for selecting it as the reference for the development.

Reference and comparison with similar and/or predecessor products: a list of comparisons describing the similarities and differences between the declared filter and similar and/or predecessor products in terms of working principle, structural composition, manufacturing materials, performance indexes, mode of action, and scope of application.

Product technical requirements should be prepared in accordance with the provisions of the ‘Guiding Principles for the Preparation of Technical Requirements for Medical Device Products’, and the standards cited in the technical indicators should be the current valid version. Common reference standards such as: YY/T 1272 ‘dialysate filter’. All components and materials should have clear correspondence, without the use of ‘series’, ‘etc.’ ambiguous words.   

Clinical evaluation information

Routine filters belonging to the products included in the Catalogue of Medical Devices Exempted from Clinical Evaluation should be provided with corresponding evaluation information in accordance with the format and content stipulated in the Technical Guidelines for Comparative Description of Products Included in the Catalogue of Medical Devices Exempted from Clinical Evaluation and other documents. If it cannot be proved that the declared products are basically equivalent to the products described in the Catalogue of Medical Devices Exempted from Clinical Evaluation, clinical evaluation should be carried out.

Sample product specifications and labels

Filter product specifications, labels and packaging markings shall meet the requirements of the ‘Regulations for the Administration of Medical Device Specifications and Labels’, YY/T 1272 ‘Dialysis Fluid Filter’ and other applicable documents. The instruction manual indicates the scope of application, and the information in the manual should contain the scope of application, maximum use pressure, contraindications (if applicable), methods of use, precautions, sterilisation methods (if applicable), performance parameters, expiry date and so on. In particular, it should indicate the maximum number of times or duration of use recommended by the filter, and the method of disinfection and cleaning (e.g. thermal disinfection, chemical disinfection, chemical thermal disinfection, etc.). The scope of application is consistent with the conclusions of the clinical evaluation and the normative documents issued by the state. It is recommended to state that ‘the use of the product must comply with the requirements of the relevant operating standards of the medical sector and relevant regulations, and is limited to the use of trained medical personnel’, ‘the total bacterial count of the ultrapure dialysis solution prepared using a single filter is not greater than 0.1 CFU/mL, which is not in line with the aseptic requirements of the injection solution, and should not be used as a replacement solution’. be used as a replacement fluid’. All information should be consistent with the conclusions of the clinical evaluation documents and the normative documents issued by the state.