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

2023-10-09T05:42:56

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

2023-10-10T04:35:45

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

2023-09-12T05:11:41

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PROVIDED that in case of large sized medical device, wherein the opinion of the Medical De...

2023-08-05T05:44:57

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

2023-08-05T04:54:18

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

2023-07-31T06:28:39

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

2023-07-31T06:27:44

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

2023-07-20T05:24:23

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

2023-07-12T04:56:33

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