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6.0 Resource management 6.1 Provision of resources The manufacturing organization shall de...

2023-10-11T04:45:03

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3.5 Implantable medical device—Medical device intended: (a) to be totally or partially int...

2023-10-09T05:40:07

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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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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) If the in vitro diagnostic medical device contains any of the following then descripti...

2023-09-16T05:06:09

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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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(B) Such summary information may include: (i) declaration or certificate of conformity to ...

2023-09-14T05:11:45

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e) a description of the accessories, other medical device and other product that are not m...

2023-09-14T04:56:32

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