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Note 2 : Provision of the medical device for purposes of clinical evaluations and/or evalu...

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The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health...

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The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health...

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18.0 Shipping stability: This section should provide information on shipping stability stu...

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(b) the intended user (lay person or professional); (c) a general description of the princ...

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1.1 Introductory descriptive information on the in vitro diagnostic medical device, the in...

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PROVIDED that the requirement of Transmissible Spongiform Encephalopathies (TSEs) or Bovi...

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

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1.8 Domestic price of the device in the currency followed in the country of origin. 1.9 L...

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