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.
Examples of factors influencing risk classification of a general medical device include the contact duration with the body, degree of invasiveness, whether the 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.
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