(ii) Documents to be submitted with the application for grant of licence to manufactu ...

11. Internal Audit: Short description of the internal audit system. 12. Contract Acti ...

What are the requirements for import of Class-A/B/C/D In Vitro Diagnostic Medical de ...

PROVIDED that no fee shall be required to be paid by the institutes, organisation, h ...

Appendix II DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC ME ...

(1) "clinical investigation" means the systematic study of an investigational medical ...

Note: 1. All reports submitted as a part of the dossier should be signed and dated by ...

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