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Whereas the draft of the Medical Devices Rules, 2016 was published, as required under sub...

2023-07-13T09:06:38

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Whereas the draft of the Medical Devices Rules, 2016 was published, as required under sub...

2023-07-12T05:31:04

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Preventive action: The manufacturer shall determine action to eliminate the causes of pote...

2023-07-06T05:36:48

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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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Vulnerable population (a) Description of the vulnerable population. (b) Description of the...

2023-07-11T05:30:29

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Responsibilities of the Ethics Committee: (i) It is the responsibility of the Ethics Commi...

2023-07-07T04:17:20

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Stability (excluding specimen stability): This section should describe claimed shelf life,...

2023-06-28T06:50:10

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DEVICE MASTER FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary An execu...

2023-06-27T05:10:11

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Fresh application in case of change in constitution In case of change in constitution of a...

2023-06-08T07:19:11

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