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Implantable medical devices and surgically invasive medical devices for long term use (a) ...

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For clinical investigations conducted in paediatric population, the reviewing Ethics Commi...

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For clinical investigations conducted in paediatric population, the reviewing Ethics Commi...

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CLINICAL INVESTIGATION (1) Approval for clinical investigation: (i) Clinical investigation...

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DEVICE MASTER FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary An execu...

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Medicinal substances: Where the medical device incorporates a medicinal substance, the dos...

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7.0 Verification and validation of the medical device 7.1 General: (A) The dossier should ...

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Parameters for classification of medical devices (i) Non-invasive medical devices which co...

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Conditions for manufacturing licence or loan licence After grant of licence or loan licenc...

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