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: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 115 of 248 1.1 Introductory descriptive information on the in vitro diagnostic medical device, the intended use and risk class of in vitro diagnostic medical device, novel features (if any), claimed shelf life and a synopsis on the content of the dossier. 1.2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device). 1.3 Domestic price of the in vitro diagnostic medical device in the currency followed in the country of origin. 1.4 Marketing history of the in vitro diagnostic medical device from the date of introducing the in vitro diagnostic medical device in the market. 1.5 List of regulatory approvals or marketing clearance obtained in below format (submit respective copy of approval certificate). SI. No. Name of the country Approved indication Approved shelf life Composition Risk Class Date of first approval 1.6 Status of pending request for market clearance Regulatory Agency of the country Intended use Indication for use Registration status and date Reason for rejection/withdrawal, if any 1.7 Safety and performance related information on the in vitro diagnostic medical device: (a) Summary of reportable events and field safety corrective action from the date of introduction For adverse event (false diagnosis or any other hazard during its use) Adverse event (false diagnosis) Frequency of occurrence during the period (number of report/total units sold) Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 116 of 248 For Field Safety Corrective Action (FSCA) Date of FSCA Reason for FSCA Countries where FSCA was conducted Description of the action taken (b) If the in vitro diagnostic medical device contains any of the following then descriptive information on the following need to be provided:— (1) Animal or human fluids or derivatives thereof, rendered non-viable. (2) Cells, tissues and / or derivatives of microbial recombinant origin. 2.0 Description and specification, including variants and accessories of the in vitro diagnostic medical device 2.1 Description The device master file should include the following device descriptive information:— (a) it may include (1) what is detected; (2) its function (for example screening, monitoring, diagnostic or aid to diagnosis, staging or aid to staging of disease); (3) the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate; (4) whether it is automated or not; (5) whether it is qualitative or quantitative; (6) the type of specimen required (e.g. serum, plasma, whole blood, tissue biopsy, urine); (7) testing population;