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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

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Our area of expertise varies from Compliance Certification ( BIS, WPC, EPR, CDSCO, Cosmeti...

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Area Of Expertise Our area of expertise varies from Compliance Certification ( BIS, WPC, E...

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FIFTH SCHEDULE [Refer rules 20(3), 20(5), 20(8), 22(i)] QUALITY MANAGEMENT SYSTEM FOR MEDI...

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

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

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17.0 In use stability: This section should provide information on in use stability studies...

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(b) If the in vitro diagnostic medical device contains any of the following then descripti...

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