7. Quality Assurance: Description of the quality assurance system and of the activiti ...

21.0 Post marketing surveillance data (vigilance reporting): The dossier should conta ...

7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstr ...

19F. Central Licensing Authority may verify the documents at any point of time and in ...

Corrective action: The manufacturer shall take action to eliminate the cause of non-c ...

Where product requirements are changed, the manufacturer shall ensure that relevant d ...

19K. Registration number for import.― The registration number for import of a class A ...

Recall detail Footnotes i Type of Product: Medicine, Medical Device, or Biological ii ...