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[Cites 0, Cited by 0] [Section 38(1)] [Section 38] [Entire Act]

Union of India - Subsection

Section 38(1)(ii) in The Medical Devices Rules, 2017

(ii)the licencee shall inform the licensing authority forthwith and, in all circumstances, within a period of fifteen days of any administrative action taken on account of any adverse reaction, such as market withdrawal, regulatory restrictions, cancellation of authorization or declaration of the medical device as not of standards quality by the regulatory authority of the country of origin or by any regulatory authority of any other country, where the medical device is marketed, sold or distributed;