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the licence holder shall, on being informed by the Central Licensing Authority or State Li...

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(v) details of competent technical staff, under whose direction and supervision the sales ...

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4.2 Documentation requirements 4.2.1 General: The quality management system documentation ...

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3.16 Rework means action taken on a non-conforming product that will fulfill the specified...

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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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11.0 Analytical specificity: (i) This section should describe interference and cross react...

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(b) An active diagnostic medical device referred to in sub-clause (1) of clause (a) shall ...

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appoint competent technical staff with degree or diploma in engineering (in relevant bran...

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PROVIDED that where deficiencies that can be rectified, are pointed out by the Central Lic...

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