What Are the Different Types of Intubation Tubes?

The scope of application of this guideline is the second category of endotracheal intubation products in the Medical Device Classification Catalogue, and the category code is now 6866.

Guiding Principles for Technical Review of Intubation Product Registration

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The scope of application of this guideline is the second category of endotracheal intubation products in the Medical Device Classification Catalogue, and the category code is now 6866.

Guiding Principles for Technical Review of Registration of Endotracheal Intubation Products

(1) The purpose of writing these guidelines is to guide and standardize the technical review of registration materials by reviewers during the registration and declaration process of type 2 tracheal intubation products.

(2) The purpose of this guideline is to allow registered reviewers who are in first contact with this type of product to have a basic understanding of the product mechanism, structure, main performance, intended use and other aspects, and to allow technical reviewers to grasp the technical review of product registration. Basic criteria, make a systematic evaluation of product safety and effectiveness.

Guiding Principles for Technical Review of Registration of Endotracheal Intubation Products

(1) Regulations on the Supervision and Administration of Medical Devices;

(2) "Administrative Measures for Medical Device Registration" (Administrative Decree No. 16);

(3) "Provisions for Clinical Trials of Medical Devices" (Administrative Decree No. 5);

(4) "Administrative Regulations on Medical Device Instructions, Labels and Packaging Marks" (Administrative Decree No. 10);

(5) "Administrative Measures for Medical Device Standards" (Administrative Decree No. 31);

(6) Notice on Printing and Distributing the "Regulations for the Examination and Approval of Registration of Class I Medical Devices (Trial)" and the "Regulations for the Examination and Approval of Registration of Class II Medical Devices (Trial)" (Guo Food and Drug Administration No. 73);

(7) Other regulatory documents issued by the State Food and Drug Administration.

Guiding Principles for the Technical Review of the Registration of Endotracheal Intubation Products

(1) The formulation of the main technical indicators and working principles of the product sought the opinion of the National Technical Committee for Biological Evaluation of Medical Infusion Devices and Medical Devices. This content is mainly based on the industry standard YY0337.1-2002 "Intubation Intubation Part 1: Common Intubation and Connectors", which should be implemented in accordance with the requirements of the latest version of the standard.

(2) The current national standards and industry standards (including product standards and basic standards) are given in the relevant standards applicable to the product.

(3) The intended use of the product combines the scope of approval of approved products for marketing and the opinions of clinical experts.

(IV) The main risks of the product shall be determined in accordance with Appendix D of YY / T0316-2003.

(5) The historical records of adverse events of products are mainly searched from the database of Shandong Provincial Center for Adverse Drug Reactions.

Guiding Principles for Technical Review of Registration of Endotracheal Intubation Products

The 2002 edition of the "Category of Medical Devices" 6866 medical polymer materials and other respiratory anesthesia or ventilation endotracheal intubation products can refer to this guideline.

Guiding Principles for Technical Review of Registration of Endotracheal Intubation Products

The authors of this guideline are composed of technical reviewers, administrative reviewers, and medical appraisers of the Shandong Food and Drug Administration's medical device product registration experts, experts from the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center, representatives of professional manufacturers, and clinical experts. In order to make full use of all aspects of information and resources, comprehensive consideration of all aspects of the guiding principles, try to ensure that the guiding principles are correct, comprehensive and practical.