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Explanation : Interference studies involve adding the potential interferent to the sample...

2023-10-04T04:37:22

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MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION 20. Application for manufactu...

2023-07-18T10:37:03

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7.5.1.1 General requirements The manufacturer shall plan and carry out production and serv...

2023-10-17T05:26:07

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DUTIES AND FUNCTIONS OF NOTIFIED BODY 1. Duties: 1. Notified body shall perform the audit ...

2023-09-11T05:02:14

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(ii) Directors, executives and personnel responsible for carrying out evaluation and verif...

2023-09-09T08:59:57

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Where the Central Licensing Authority or the State Licensing Authority has reason to beli...

2023-07-20T05:08:14

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19K. Registration number for import.― The registration number for import of a class A non...

2023-07-18T10:32:54

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(iii) an undertaking from the importer stating that the proposed device is Class A non-ste...

2023-07-18T10:31:42

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PROVIDED that, — (i) no audit of the manufacturing site shall be necessary prior to grant ...

2023-07-20T05:03:44

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