Guide to the application dossier for inclusion, for ...（指南包含应用程序档案,u2026u2026）.pdf

MEDICAL DEVICES ASSOCIATED PRODUCTS AND SERVICES COVERED BY THE LPP Guide to the application dossier for inclusion, for modification of the conditions for inclusion and for the renewal of inclusion of a product or service under a brand name on the list referred to in Article L.165-1 to be submitted to the National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) Manufacturer’s Guide - Updated 2011_8 November p. 1/29 Summary ABBREVIATIONS 3 INTRODUCTION 4 GUIDELINES ON COMPILING THE DOSSIER 6 SUBMISSION METHODS 7 ADMINISTRATIVE DOCUMENTS TO BE INCLUDED WHEN THE DOSSIER IS SUBMITTED 9 MODEL FORMAT OF THE DOSSIER TO BE SUBMITTED TO THE CNEDIMTS 10 SUMMARY OF THE APPLICATION 11 PART I: IDENTIFICATION OF THE APPLICATION 12 1. The applicant 12 2. Administrative information 12 3. Type of application 13 4. Product or service concerned 14 4.1 If the application relates to a product: 14 4.2 If the application relates to a service: 15 PART II: MEDICO-TECHNICAL DOSSIER 16 1. Descriptive information on the product and/or service 16 2. Identification and selection of the available clinical data 17 3. Demonstration of the expected benefit/actual benefit claimed by the applicant 18 4. Applicant’s proposals regarding the conditions for prescription and use 22 5. Demonstration of the improvement in expected/actual benefit claimed by the applicant 22 6. Target population 23 NON-EXHAUSTIVE LIST OF LINKS WHICH CAN BE USED FOR SYSTEMATIC LITERATURE SEARCHES AND TO SEARCH FOR EPIDEMIOLOGICAL DATA 24 APPENDICES 25 EXAMPLE OF SUMMARY IN TABLE FORM TO BE COMPLETED 26 INFORMATION TO BE PROVIDED TO ENABLE PARALLEL ASSESSMENT OF THE PROCEDURE ASSOCIATED WITH THE MEDICAL D