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

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the licence holder shall, on being informed by the Central Licensing Authority or State Li...

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Additional elements, which may be required (a) Statement of foreseeable circumstances und...

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Device accountability Description of the procedures for the accountability of investigatio...

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

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Validity of licence A licence granted under sub-rule (1) of rule 36 shall remain valid in ...

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

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Additional elements, which may be required (a) Statement of foreseeable circumstances unde...

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Informed consent process (a) Description of the general process for obtaining informed co...

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