Note: 1. All reports submitted as a part of the dossier should be signed and dated by the responsible person. 2. Batch Release Certificates and Certificate of Analysis of finished product for minimum 3 consecutive batches should be submitted. 3. All certificates submitted must be within the validity period. 4. Any information which is not relevant for the subject device may be stated as 'Not Applicable' in the relevant Sections/Columns of the above format, and reasons for non-applicability should be provided. Appendix III DEVICE MASTER FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary An executive summary shall be provided by the manufacturer and shall contain