Transcription of MEDICAL DEVICE GUIDANCE DOCUMENT - …
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MEDICAL DEVICE GUIDANCE DOCUMENT - …
MEDICAL DEVICE GUIDANCE DOCUMENT MEDICAL DEVICE CONTROL DIVISION Ministry of Health, Malaysia GD-XX GUIDANCE ON THE CLASSIFICATION OF MEDICAL DEVICE DRAFT Classification Of MEDICAL DEVICE 2 | P a g e Table of Contents Introduction .. 3 Purpose .. 4 Scope .. 4 Terms and Definitions .. 4 General Principles .. 7 Factors Influencing DEVICE Classification .. 7 General Classification of MEDICAL devices .. 9 Determination of DEVICE Class Using Rules-Based System .. 9 Classification Rules for MEDICAL devices .. 10 Rationale For The Inclusion Of The Additional 23 Appendix A: Decision trees to demonstrate how the rules may be used to classify specific devices .
medical device guidance document medical device control division ministry of health, malaysia gd-xx guidance on the classification of medical device
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