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Recall Action Commencement Date: The date the recall strategy and communication was agreed...

2023-10-20T06:47:07

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Examined periodically, at least once a year. Records shall be maintained thereof. 6.2.2 Co...

2023-10-11T04:45:17

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Top management of the manufacturer shall ensure that responsibilities and authorities are ...

2023-10-11T04:38:35

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the permission holder shall inform the date of launch of medical device in the market to ...

2023-08-05T05:38:39

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General: Personnel performing work affecting product quality shall be competent on the bas...

2023-07-05T05:09:04

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Management representative: Top management shall appoint a member of management who, irresp...

2023-07-04T04:52:32

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Condition of permission to import or manufacture medical device which does not have its pr...

2023-06-19T05:55:02

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Resource management 6.1 Provision of resources The manufacturing organization shall determ...

2023-05-25T05:48:06

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Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensure that qu...

2023-05-25T05:11:46

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