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

2023-03-23T06:35:38

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

2023-09-16T05:31:26

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Preventive action: The manufacturer shall determine action to eliminate the causes of pote...

2023-07-06T05:36:48

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

2023-06-27T05:36:21

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

2023-06-27T05:11:45

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ENVIRONMENTAL REQUIREMENT FOR MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES Nam...

2023-05-27T06:56:34

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

2023-05-20T06:48:45

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MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATI...

2023-04-28T05:08:30

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MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATI...

2023-04-28T05:08:10

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