Transcription of Revision 7. 5
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Revision 7. 5
AUGUST 2021. MEDICAL DEVICE GUIDANCE. GN-15: Guidance on Medical Device Product Registration Revision 7. 5. MEDICAL DEVICE GUIDANCE AUGUST 2021. CONTENTS. PREFACE .. 4. 1. INTRODUCTION .. 5. Scope .. 6. Definitions .. 6. 2. RISK CLASSIFICATION FOR MEDICAL DEVICES .. 9. 3. REGISTRATION OF MEDICAL DEVICES .. 11. Class A Medical Devices .. 11. Grouping Requirements for Product Registration .. 12. Telehealth Medical Devices, Devices for Modification of Appearance or Anatomy and 3D-printed Medical Devices .. 12. 4. REGISTRATION OF CLASS B MEDICAL DEVICES .. 14. Evaluation Routes .. 14. Submission Requirements .. 18. Processing of Application .. 19. Processing of application for Full / Abridged Evaluation Route .. 19. Processing of application for IBR Evaluation Route.
• supplying the health product to a person or an institution concerned with scientific education or research which requires the health product for the purpose of education or research; • supplying the health product to a person who requires the health product for the purpose of enabling him to comply with any requirements made by, or
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