What Are the Medical Uses of Chuchuhuasi?

In order to strengthen the supervision and guidance of medical device product registration and further improve the quality of registration review, the State Food and Drug Administration has formulated the "Guiding Principles for the Technical Review of Registration of Absorbable Hemostatic Products"

Guidelines for the technical review of the registration of absorbable hemostatic products

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In order to strengthen the supervision and guidance of medical device product registration and further improve the quality of registration review, the State Food and Drug Administration has formulated the "Guiding Principles for the Technical Review of Registration of Absorbable Hemostatic Products"

This guideline is intended to help and guide applicants / manufacturers in preparing the application information for the registration of absorbable hemostatic products to meet the basic requirements of technical review. At the same time, it helps the review agency to conduct scientific and standard review of this type of products, and improves the quality and efficiency of the review.

This guideline is a general requirement for the registration application information of absorbable hemostatic products. Applicants / manufacturing enterprises should enrich and refine the content of registration application materials according to the characteristics of specific products. The production enterprise should also determine whether the specific content is applicable based on the characteristics of the specific product. If it is not applicable, the reason and corresponding scientific basis shall be specified.

This guideline is a guidance document for production enterprises and reviewers, but does not include administrative matters involved in registration approval, nor is it enforced as regulations. If there are other methods that can meet the requirements of relevant regulations, they can also be used, but they need Provide detailed research data and verification data. This guideline should be used in compliance with relevant regulations.

This guideline is formulated under the current system of laws and standards and the current level of cognition. With the continuous improvement of laws and standards, and the continuous development of science and technology, the relevant content of this guideline will also be adjusted in a timely manner. ^[1]

This guideline is intended to help and guide applicants / manufacturers in preparing the application information for the registration of absorbable hemostatic products to meet the basic requirements of technical review. At the same time, it helps the review agency to conduct scientific and standard review of this type of products, and improves the quality and efficiency of the review.

This guideline is a general requirement for the registration application information of absorbable hemostatic products. Applicants / manufacturing enterprises should enrich and refine the content of registration application materials according to the characteristics of specific products. The production enterprise should also determine whether the specific content is applicable based on the characteristics of the specific product. If it is not applicable, the reason and corresponding scientific basis shall be specified.

This guideline is a guidance document for manufacturing enterprises and reviewers, but does not include administrative matters involved in registration approval, nor is it enforced as regulations. If there are other methods that can meet the requirements of relevant regulations, they can also be used, but they need to be used. Provide detailed research data and verification data. This guideline should be used in compliance with relevant regulations.

This guideline is formulated under the current system of laws and standards and the current level of cognition. With the continuous improvement of laws and standards, and the continuous development of science and technology, the relevant content of this guideline will also be adjusted in a timely manner.

This guideline is applicable to the preparation of registration information and product technical review of absorbable hemostatic medical device products.

Absorbable hemostatic medical devices refer to medical device products that can be absorbed by the human body during surgery when conventional hemostatic techniques are ineffective. Such products can produce hemostatic effects by accelerating the coagulation process of local blood on the wound surface. . At present, most of these products are made of the following materials: oxidized cellulose, regenerated oxidized cellulose, starch and other plant polysaccharides, absorbable gelatin, collagen, etc.

This guideline does not apply to devices that control bleeding at the anastomosis of blood vessels (such as polymer-based sealants), devices that temporarily close blood vessels (such as vascular clamps / clamps), or those that contain thrombin and / or other drugs or biological agents. Absorb hemostatic device. ^[1]

Absorbable hemostatic products: refer to medical device products that can be absorbed by the human body during surgery when conventional hemostatic techniques are ineffective. Such products can produce hemostatic effects by accelerating the coagulation process of local blood on the wound. ^[1]