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

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Risk analysis and control summary: The device master file should contain a summary of the ...

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Description and specification, including variants and accessories of the in vitro diagnost...

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The device master file should include the following device descriptive information:— (a) i...

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(b) If the device contains any of the followings, then descriptive information on the fol...

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If the device contains any of the followings, then descriptive information on the follow...

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Current practice The generic drugs produced in India and in all well-regulated markets (US...

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Good laboratory practices and requirements of premises and equipment 1. General Requiremen...

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Good laboratory practices and requirements of premises and equipment 1. General Requiremen...

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