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(i) for medical devices intended to emit ionizing radiation, information on radiation sour...

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

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(xii) Active therapeutic medica I devices for administering or exchanging energy (a) Subje...

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

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7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in direct or...

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(b) An active diagnostic medical device referred to in sub-clause (1) of clause (a) shall ...

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BIO-COMPATIBILITY AND ANIMAL PERFORMANCE STUDY FOR INVESTIGATIONAL MEDICAL DEVICE 1. Rece...

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BIO-COMPATIBILITY AND ANIMAL PERFORMANCE STUDY FOR INVESTIGATIONAL MEDICAL DEVICE 1. Rece...

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7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in direct or...

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