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  • I agree with Dan's interpretation for the US that said: "QSIT, in the narrative portion of Design Controls, Inspectional Objective #1, says, "Do not inspect a device under design control requirements to determine whether the design was appropriate or safe and effective. This is precluded under Section 520(f)(1)(A) of the Act .... I infer that ...

  • Hello, There are 2 scenarios: 1. In Ideal situation to retain your MA in Asia, you need to first transfer your MA to the new partner and in several Asian countries, it requires Letter of transfer rights from your existing partner. 2.In worst case scenario, if your existing partner is not co-operating then you might have to search for a new partner ...

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    RE: India again

    Hi Ginger, I have been working with MD regulations with CDSCO and can answer your few questions: 1.The local Indian manufacturer who have been manufacturing and supplying MD before the new 2017 law came into effect are still continuing without MD Approvals. This is allowed but it is again the responsibility of manufacturer of MD to ensure that MD ...

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