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  2. Search results for "substantial equivalence evaluation"
Home / Search results for "substantial equivalence evaluation"

PRESENTATION AND SUBMISSION OF APPLICATION 1. In order to make regulatory review process a...

2023-10-30T06:19:04

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7.4 Purchasing 7.4.1 Purchasing process: The manufacturer organisation shall establish doc...

2023-10-13T05:24:17

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7.3.6 Design and development validation: Design and development validation shall be perfor...

2023-10-13T05:21:41

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

2023-10-13T05:22:38

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As part of design and development validation, the manufacturer shall perform clinical eval...

2023-11-04T06:17:57

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Design and development validation: Design and development validation shall be performed in...

2023-11-04T06:10:50

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3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer a...

2023-10-28T05:42:42

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5. Clear policy on regulatory requirements, system and procedures is critical for efficien...

2023-10-28T05:39:56

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5. Clear policy on regulatory requirements, system and procedures is critical for efficien...

2023-10-26T05:37:00

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