(7) All registers and records mentioned under these rules, shall be preserved for a p ...

(b) If the device contains any of the followings, then descriptive information on th ...

7.4 Biological safety: (i) The dossier should contain a list of all materials of anim ...

Best Regulatory Affair in Delhi NCR. iv Recall Action Level: The level to which the r ...

Sugam builds a comprehensive database of the various permissions and licenses issued ...

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

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

5.6.2 Review input: The input to management review shall include information on— (a) ...