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(i) for medical devices intended to emit ionizing radiation, information on radiation sour...

2023-09-14T04:57:28

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7.3.2 Design and development inputs: Inputs relating to product requirements shall be dete...

2023-10-13T05:18:32

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3.18.2 Design validation means establishing by objective evidence that device specificatio...

2023-10-09T05:45:47

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(b) the intended user (lay person or professional); (c) a general description of the princ...

2023-09-16T05:31:26

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(ii) Evidence of the ongoing revalidation of the process should also be provided. Typicall...

2023-09-16T04:49:56

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7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in direct or...

2023-09-16T04:43:15

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

2023-08-04T04:51:07

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the licence holder shall, on being informed by the Central Licensing Authority or State Li...

2023-07-20T06:23:58

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Design and development inputs: Inputs relating to product requirements shall be determined...

2023-07-05T05:22:42

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