Note: 1. All the test 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 in vitro diagnostic medical device may be stated as 'Not Applicable' in the relevant sections/ columns of the above format, and reasons for non applicability should be provided.