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Abbreviated terms and definitions A list of abbreviated terms and definitions of specializ...

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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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REGULATION OF MEDICAL DEVICE 4. Classification of medical devices (1) Medical devices othe...

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(ii) Documents to be submitted with the application for grant of licence to manufacture or...

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

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REGISTRATION OF LABORATORY FOR CARRYING OUT TEST OR EVALUATION 81. Application for regist...

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PROVIDED that no fee shall be required to be paid by the institutes, organisation, hospit...

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

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(iv) the manufacturer shall self-certify that the product is conforming to the essential p...

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