(1)If a manufacturer or authorized agent, as the case may be, considers or has reasons to believe that a medical device, which has been imported, manufactured, sold or distributed, is likely to pose risk to the health of a user or patient during its use and therefore may be unsafe, such manufacturer or authorized agent shall immediately initiate procedures to withdraw the medical device in question from the market and patients, indicating reasons for its withdrawal and inform the competent authority the details thereof.(2)A manufacturer or authorized agent, as the case may be, shall immediately inform the competent authority and cooperate with them, if there are reasons to believe that a medical device which has been placed in the market, may be unsafe for the patients.(3)The manufacturer or importer or authorized agent, as the case may be, shall inform the competent authority of the action taken to prevent risk to the patient and shall not prevent or discourage any person from cooperating, in accordance with the provisions of the Act and these rules, with the competent authorities, where this may prevent, reduce or eliminate a risk arising due to use of such medical device.
