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UNDERTAKING BY THE INVESTIGATOR 1. Full name, address and title of the Principal Investig...

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Design and development review: At suitable stages, systematic reviews of design and develo...

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3. To enhance the communication aspects, CDSCO should ensure that the industry representat...

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7.3.4 Design and development review: At suitable stages, systematic reviews of design and ...

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Top management of the manufacturer shall ensure that responsibilities and authorities are ...

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(2) Our Authorised agent shall, — (a) act as the official representative for obtaining imp...

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THIRD SCHEDULE [Refer rules 13(5), 13(9), 14, 15, 20(4), 20(6)] DOCUMENTS REQUIRED FOR REG...

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Recall detail Footnotes i Type of Product: Medicine, Medical Device, or Biological ii TGA ...

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CLINICAL INVESTIGATION REPORT 1. General This table specifies the contents of the clinical...

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