Clinical evidence: The dossier should contain the clinical evidence that demonstrates conformity of the device with the Essential Principles that apply to it. It needs to address the elements contained in the Clinical Investigation, as specified under the Seventh Schedule. If a predicate device is available, the manufacturer needs to submit the substantial equivalence evaluation along with relevant published literature in accordance with these rules. 7.10 Post Marketing Surveillance data (Vigilance reporting): The dossier should contain the Post Marketing Surveillance or Vigilance Reporting procedures and data collected by the manufacturer encompassing the details of the complaints received and corrective and preventive actions taken for the same. 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.