ofac general license iran medical devices

Both the foreign company and Indian company jointly needs to submit the documentation for medical device and manufacturing unit.

An Import license is issued for import of medical device from other country to India. Operon Strategist assists medical device distributors and medical device wholesalers in India to procure CDSCO import license. In the process of rejection the applicant can make an appeal to the Central Government within the time of forty five days and that the Government, may after the enquiry in this matter pass order in relation there within the time of ninety days from the date of appeal.After examining the documents along with the application on the basis of the inspection report, if the inspection has been done by the Central Licensing Authority can be satisfied, grant license in Form MD-15 may reject this application for this reasons shall be recorded in writing within the time of nine months from the date of the application.Where the Central Licensing Authority, has reason to believe that the quality of the medical device is compromised, and decides to subject to its evaluation, tests or evaluation, test or examination, to the testing laboratory as specified by the Central Licensing Authority.An authorized agent (who must have wholesale license for local distribution) having license to manufacture for sale or distribution or wholesale license for sale or distribution under these rules, shall make an application for grant of import license for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a license.CDSCO has complete procedure for granting license for medical device imported in the countries.Īpplication for grant of import license for medical device However they need to be classified according to CDSCO notified devices list. India CDSCO Import License for Medical Devices In India Medical Device Import License:Īpplicable when we have to import medical devices from other countries to India.

Ofac general license iran medical devices