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Union of India - Section

Section 91 in The Medical Devices Rules, 2017

91. Export of medical devices.

- Where a person intends to export any medical device, manufactured in India, and for that purpose, requests a certificate in the nature of free sale certificate or a certificate about quality, safety and performance in relation to that medical device as required by the authority concerned of the importing country, such person, may apply to the Central Licensing Authority for the purpose along with a fee as specified in the Second Schedule and the said authority shall, if the requirements are fulfilled, issue a certificate to the applicant.