Guidelines for Registration Review of Absorbable Surgical Sutures (Revised 2023)

Preface:

This guideline is intended to guide the applicant for registration in the preparation and writing of registration data for absorbable surgical sutures.

The purpose of this guideline is to guide the applicant to prepare and write the registration data of absorbable surgical sutures, and also to provide reference for the technical review department to review the registration data.

This guideline is a general requirement for the registration of absorbable surgical sutures, the applicant should be based on specific product characteristics to determine whether the content of which is applicable, if not, need to specify the reasons and the corresponding scientific basis, and based on the specific characteristics of the product to enrich and refine the content of the registration information.

This guideline is a guiding document for applicants and reviewers, does not involve administrative matters such as registration and approval, and is not mandatory as a law, if there are other methods to meet the requirements of the relevant laws and regulations can also be used, but should provide detailed information on the research and validation information. This guideline should be used under the premise of complying with relevant regulations.

This guideline is formulated under the current regulations and standards and the current level of knowledge, with the continuous improvement of regulations and standards and the continuous development of science and technology, the relevant contents of this guideline will be adjusted in due course.

Scope of application

Absorbable surgical sutures (hereinafter referred to as absorbable sutures) covered by this guideline are processed from healthy mammalian collagen or synthetic polymers that can be absorbed by human tissues. Materials covered include absorbable synthetic materials such as polyglycolide (aka polyglycolic acid PGA), polyglycolide-propylglycolide copolymer (PGLA), poly(p-dioxane) (PPDO), and materials of animal origin. Absorbable sutures may be impregnated or treated with suitable coatings, softeners, and may be in single or multi-stranded form.

This guideline applies to absorbable sutures for suturing and ligating human tissues.

This guideline does not apply to facial implants, facial lifts, sutures intended for osseointegration, and non-absorbable surgical sutures.

Key points for registration review

(A) Regulatory information

1. Application form

1.1 Confirm the category and classification code of the product, according to the "Medical Device Classification Catalog", the regulatory category of absorbable sutures is Class III medical devices, classification code 02-13-06.

1.2 Focus on the Chinese name of the product, the naming should be in line with the "Naming Rules for Common Names of Medical Devices" and other relevant guidelines for naming medical devices, such as "Absorbable Surgical Suture", "Synthetic Absorbable Suture", "Absorbable surgical barbed suture".

For imported registered products, the original name of absorbable sutures should be consistent with the country of origin of the marketing documents and the corresponding content of the country of origin instructions.

2. Product List

2.1 For imported registered products, absorbable sutures of the specifications of each model, the structure of the composition should be consistent with the country of origin of the marketing documents and the country of origin instructions in the corresponding content.

2.2 Product registration unit should be divided in principle in line with the "Guiding Principles for the Division of Medical Device Registration Unit" requirements, absorbable sutures with different materials should be divided into different registration unit for reporting; different structural design (such as barbed sutures and ordinary sutures) affect the safety and effectiveness of the product should be divided into different registration units.

(B) the synthesis of information

(C) non-clinical information

(D) clinical evaluation

Absorbable sutures are not currently "exempt from clinical evaluation of medical devices catalog" included products, should be in accordance with the "Technical Guidelines for the Clinical Evaluation of Medical Devices" and other documents specify the format and content of the corresponding clinical evaluation information.

(E) Product manuals and labels

(F) Quality management system documents