Explanation : For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes without any notice.] (iv) Free sale certificate from country of origin. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India (v) undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic.