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2.0 Device description and product specification, including variants and accessories 2.1 T...

2023-09-14T04:54:40

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2.0 Device description and product specification, including variants and accessories 2.1 T...

2023-09-13T05:26:51

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Existing clinical data (a) Summary of relevant previous clinical experience with the inv...

2023-07-10T11:07:10

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Actions taken in reporting interval for safety reasons: This section of PSUR shall include...

2023-07-08T06:48:46

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Device description and product specification, including variants and accessories 2.1 The d...

2023-06-27T04:38:34

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LABELLING OF MEDICAL DEVICES 44. Labelling of medical devices The following particulars s...

2023-06-08T07:29:11

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Preclinical testing Summary of preclinical testing that has been performed on the investi...

2023-05-30T04:43:09

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A PSUR should be structured as follows:— (a) Title Page: The title page of PSUR shall capt...

2023-05-29T09:13:40

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If the device contains any of the followings, then descriptive information on the follow...

2023-05-20T05:35:46

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