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The manufacturer shall ensure that changes to documents are reviewed and approved either b...

2023-10-10T04:34:14

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Data may be recorded by electronic data processing systems or other reliable means, but do...

2023-10-10T04:30:01

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

2023-09-16T05:04:26

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3.0 Labelling: The dossier should typically contain a complete set of labeling associated ...

2023-09-14T04:58:20

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1.2 Information regarding sterilization of the device (whether it is sterile or non-steril...

2023-09-13T05:06:07

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(viii) when any major non-compliance is observed during audit by the notified body which m...

2023-09-11T05:06:07

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(vi) assess conformity to the product and process standards as per provisions of these rul...

2023-09-11T05:05:13

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THIRD SCHEDULE [Refer rules 13(5), 13(9), 14, 15, 20(4), 20(6)] DOCUMENTS REQUIRED FOR REG...

2023-09-09T08:58:10

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87D. Suspension and cancellation of Registration Certificate.— (1) Where the registration ...

2023-08-29T04:42:44

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