Transcription of MEDICAL DEVICE GUIDANCE DOCUMENT
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MEDICAL DEVICE GUIDANCE DOCUMENT
MEDICAL DEVICE CONTROL DIVISION. Ministry of Health, Malaysia MEDICAL DEVICE GUIDANCE . DOCUMENT . GD-XX. GUIDANCE ON THE COMMON SUBMISSION. DOSSIER TEMPLATE (CSDT) OF IVD MEDICAL . DEVICE . DRAFT. Common Submission Dossier Template (CSDT) of IVD MEDICAL DEVICE Table of Contents 3. 3. 3. Terms and Definitions .. 3. Preparation of a Product Registration Submission Based on the ASEAN CSDT .. 5. Executive 6. 4. Elements Of The Common Submission Dossier Template .. 9. Relevant Essential Principles and Method Used to Demonstrate 9. DEVICE Description ..11. DEVICE description and features ..11. Intended use ..12. Instructions of use ..13. Limitations ..13. Warnings ..14. Precautions ..14. Materials ..15. Other Relevant Other Descriptive Product Verification and Pre-clinical Clinical Evidence ..23. DEVICE Risk Analysis ..31. Manufacturer Information ..32. ANNEX 1 ..35. 2|Page Common Submission Dossier Template (CSDT) of IVD MEDICAL DEVICE Introduction This GUIDANCE DOCUMENT provides recommendations on the content of Common Submission Dossier Template (CSDT) to be assembled and submitted to a Regulatory Authority or Conformity Assessment Body.
medical device guidance document medical device control division ministry of health, malaysia gd-xx guidance on the common submission dossier template (csdt) of ivd medical
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