Thank you Murni.
Murni, does it means that I need to incorporate my Tech File into a CSDT? Should the title be changed too?
I am a newbie here and is arranging for registration of medical device.
Hi Hakim,
Peace be upon you.
Yes you may want to change the title.
Sharing my note on preparing Malaysia CSDT;
6 Elements of CSDT for ABC system.
6.1 Executive summary
-regulatory approvals and commercial marketing history
6.2 Relevant essential principles and rule used to demonstrate conformity
- provide EP checklist and DOC
6.3 Description of medical device
- provide manuals,ifu
6.4 Summary of design verification and validation documents
6.4.1 Pre-clinical studies
-biocompatibility/preclinical test/preclinical animal studies
6.4.2 Software validation studies
-software validation report
6.4.3 Medical devices containing biological material
-details are requested in guidance 3.too long to type....haha
6.5 Clinical evidence
-Clinical evaluation report
6.6 Use of existing bibliography
-clinical papers
6.7 Medical device labelling
-sample of labelling, IFU, manuals.
6.8 Risk analysis
-Risk management report/analysis
6.9 Manufacturer information
-Manufacturing process, QMS certification.
APPENDIX A – Essential Principles Conformity Checklist - MDA template
APPENDIX B – List of configurations of medical device to be registered - MDA template from MedC@st
