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11.0 Analytical specificity: (i) This section should describe interference and cross react...

2023-10-04T04:27:55

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Best Medical Licences. Professional Licenses: Many professions, such as doctors, lawyers, ...

2023-10-21T04:42:16

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Note: Configuration management is a means by which identification and traceability can be...

2023-10-17T05:40:48

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The manufacturer shall establish and maintain a record for each batch of medical device or...

2023-10-17T05:27:04

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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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7.4 Biological safety: (i) The dossier should contain a list of all materials of animal or...

2023-09-16T04:47:13

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agents, contractors and sub-contractors, and clinical investigation sites shall be open fo...

2023-08-05T04:56:58

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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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