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4.2.3 Control of documents : Documents required by the quality management system shall be ...

2023-10-10T04:32:42

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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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What are the requirements for import of Class-A/B/C/D In Vitro Diagnostic Medical device ...

2023-10-31T12:24:26

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POLICY ON POST-APPROVAL STUDIES 1. Post-approval studies may be required to provide additi...

2023-10-30T06:18:22

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15.However, detailed guidance documents should be prepared providing the requirements and ...

2023-10-28T05:49:46

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After the NDA is accepted the various section of the application should undergo concurrent...

2023-10-26T11:13:04

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The manufacturer shall ensure the adequacy of specified purchase requirements prior to the...

2023-10-16T07:29:04

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Purchasing information shall describe the product to be purchased, including where appropr...

2023-10-13T05:25:10

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Where product requirements are changed, the manufacturer shall ensure that relevant docume...

2023-10-13T05:15:42

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