Rejection of application If any document submitted by an applicant for grant of licen ...

INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR MANUFAC ...

22.0 Information required to be submitted for the in vitro diagnostic medical device: ...

Studies: This section of PSUR shall capture the brief summary of clinically important ...

Appendix I CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a s ...

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

THIRD SCHEDULE [Refer rules 13(5), 13(9), 14, 15, 20(4), 20(6)] DOCUMENTS REQUIRED FO ...

Design and development inputs: Inputs relating to product requirements shall be deter ...