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Exemption from provisions related to medical devices (1) The medical devices specified in the Eighth Schedule shall be exempt from the provisions of these rules to the extent and subject to the conditions specified in that Schedule. (2) The Central Government may, by notification, from time to time, amend or modify the entries in the Eighth Schedule. 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.
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