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

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Permission to import or manufacture new in vitro diagnostic medical device (1) An applica...

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IMPORT OR MANUFACTURE MEDICAL DEVICE WHICH DOES NOT HAVE PREDICATE DEVICE 63. Permission ...

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(iii) a table compiling all observed device deficiencies that could have led to a serious ...

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REQUIREMENTS FOR PERMISSION TO IMPORT OR MANUFACTURE INVESTIGATIONAL MEDICAL DEVICE FOR ...

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

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Permission to import or manufacture new in vitro diagnostic medical device (1) An applica...

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Medical management Where any participant is injured on account of his participation in the...

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Medical management Where any participant is injured on account of his participation in the...

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