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4.2.2 Quality manual: The manufacturer shall establish and maintain a quality manual that ...

2023-10-10T04:30:57

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1.8 Domestic price of the device in the currency followed in the country of origin. 1.9 L...

2023-09-13T05:15:38

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Sugam builds a comprehensive database of the various permissions and licenses issued by S...

2023-12-29T05:07:19

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(3) In case of imported diagnostic in vitro diagnostic medical devices, the report of eval...

2023-10-05T05:38:09

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22.0 Information required to be submitted for the in vitro diagnostic medical device: (1) ...

2023-10-05T05:34:31

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21.0 Post marketing surveillance data (vigilance reporting): The dossier should contain th...

2023-10-05T05:33:42

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7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstrates ...

2023-09-16T04:55:48

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3. Premises and Facilities: (i) layout of premises with indication of scale; (ii) nature o...

2023-09-12T05:12:30

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Appendix I CONTENTS OF A SITE OR PLANT MASTER FILE The manufacturer shall prepare a succin...

2023-09-12T05:11:41

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