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Appendix I
2023-09-13T05:03:20
Accredited Consultants Pvt Ltd
Appendix IIDEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICES1.0 Executi

Appendix II DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary: An executive summary shall be provided by the manufacturer and shall contain: 1.1 Introductory descriptive information on the medical device, the intended use and indication for use, class of device, novel features of the device (if any), shelf life of the device and a synopsis on the content of the dossier.

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