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 .. 25 Classification Of MEDICAL DEVICE 3 | P a g e Introduction Regulatory controls are intended to safeguard the health and safety of patients, users and others by ensuring that Manufacturers of MEDICAL devices follow specified procedures during design, manufacture and marketing.

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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  Devices, Document, Medical, Guidance, Medical device, Medical device guidance document, Medical device guidance document medical device

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