The Drugs Controller General of India has extended the deadline for submitting notarized documents online through Sugam portal for import of medical devices along with in-vitro diagnostics (IVDs). The dead line has been extended till 4 months or till normalization of COVID-19 situation.The earlier deadline was April 24, 2020.
The step was taken by DGCI after receiving representations on all issues related to submitting all notarized or apostilled documents like power of attorney, free sale certificate or QMS certificate required for applications for medical device and in-vitro diagnostics kits import under medical device rules India.
All such applications when received will be processed and when found satisfactory, the import license will be issued with a condition that the concerned firm will submit apostilled or the notarized documents after the COVID-19 situation becomes normal or within four months whichever comes earlier. But the concerned person or firm has to submit an undertaking for submission of documents within the mentioned time frame.
Previously, DCGI had also clarified regarding the RUO products that all imported in-vitro diagnostic kits that will be used only by the Indian Research Institutions for the academic purposes and not for any therapeutic or diagnostic purposes in any of the diagnostic hospitals and labs.
It was further clarified that the products that are to be used for research only should be used for the academic purpose and not for any kind of diagnostic or therapeutic purposes.
They are not under the regulation of Drugs and Cosmetics act as well as medical device rules. Furthermore, the applicant has to submit an undertaking that states that the imported product will be used by research institutions for academic purposes only. All those products must be labelled as"for research use only".
Thus, these were some of the recent changes made by DCGI for import and use of medical devices and in-vitro diagnostic kits given Covid-19.However, in light of the recent events. It seems very unpredictable as to how this situation will suffice. Moreover, COVID-19 is claiming more and more live each day.
This is a commendable step taken by the authorities. As businesses have taken the worst impact from this situation and should be give nample time to recuperate.
