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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

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INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy ...

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

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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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If the medical device is intended to treat serious or lifethreatening diseases, occurring...

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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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"specimen receptacle" means a device, whether vacuum type or not, specifically intended b...

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