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Friday, July 10, 2020 1:00:03 PM
Registration in those countries where such documentation is required is the responsibility of the distributor.
The registration of an imported medical device will go NOWHERE without conclusive clinical test data! And the clinical test data will then be public information!
The registration and approval to distribute an imported medical device is not a simple task! It is a very good bet the so-called distributors may not be equipped to accomplish the registration and/or willing to foot the bill!
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