The Department of Health and Family Welfare vide notification dated the 4th March, 2022 has issued the Medical Devices (2nd Amendment) Rules, 2022. The amendment provides that where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, United Kingdom United States of America, an import licence shall be granted to the applicant without carrying out clinical investigation.
