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 .. 19. General Notes .. 20. 5. REGISTRATION OF CLASS C AND D MEDICAL 22. Evaluation Routes .. 22. Submission Requirements.
medical device delivers medicinal products or energy to the patient, whether they are intended to have a biological effect on the patient and local versus systemic effects, etc. A general medical device may also be incorporated with a medicinal product in an ancillary role to achieve its intended purpose (please refer to
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