Details of suspected adverse device reaction(s): (a) Full description of reaction(s) ...

4.2 Documentation requirements 4.2.1 General: The quality management system documenta ...

Conditions for manufacturing licence or loan licence After grant of licence or loan l ...

AUTHORITIES, OFFICERS AND BODIES 8. Licensing Authorities (1) The Central Licensing A ...

THE WIRELESS PLANING AND COORDINATION (WPC) Wing in India is responsible for the pla ...

Overall synopsis of the clinical investigation A summary or overview of the clinical ...

3.18.2 Design validation means establishing by objective evidence that device specifi ...

In this context, Accredited Consultants Pvt Ltd (ACPL) serves as a regulatory consult ...