information about any report of suspected unexpected serious adverse event occurring ...

Conditions for permission to conduct of clinical performance evaluation After grant ...

UNDERTAKING BY THE INVESTIGATOR 1. Full name, address and title of the Principal Inv ...

CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a succinct doc ...

3.10 Finished device means any device or accessory to any device that is suitable for ...

Suspension, cancellation, etc. of permission (1) If any person to whom permission ha ...

5.0 Management responsibility 5.1 Management commitment Top management of the manufac ...

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