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

2023-06-28T10:42:43

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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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Management commitment Top management of the manufacturer shall provide evidence of its com...

2023-07-04T04:47:00

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

2023-06-26T04:50:30

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Application for test or evaluation of medical device For the purpose of these rules, an ap...

2023-06-19T06:15:53

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

2023-06-09T05:18:45

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Permission to conduct clinical investigation The Central Licensing Authority, after such f...

2023-06-09T05:05:18

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Validity of licence A licence granted under sub-rule (1) of rule 36 shall remain valid in ...

2023-06-08T05:45:57

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

2023-06-08T04:32:48

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