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(e) An active diagnostic medical device shall be assigned to Class C, if it is intended fo...

2023-09-02T09:23:45

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2. Applicability: The provisions of this Schedule shall be applicable to manufacturers of ...

2023-10-09T05:29:01

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2. Applicability: The provisions of this Schedule shall be applicable to manufacturers of ...

2023-10-07T11:18:02

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(b) An active diagnostic medical device referred to in sub-clause (1) of clause (a) shall ...

2023-09-02T09:21:47

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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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(xiv) Other active medical devices An active medical device to which provisions of sub-par...

2023-09-02T09:24:35

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3.2 Active medical device—Medical device relying for its functioning on a source of electr...

2023-10-09T05:29:04

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

2023-09-16T04:43:15

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