CDSCO Import license of medical devices is regulated in India that any enterprise or an individual having license (wholesale and/or manufacturing license issued under vital drug standard control organization (CDSCO), capsules and cosmetics act, 1940 and can import medical devices into India.
below the brand new dispensation, overseas manufacturers have to practice for registration certificate for their manufacturing premises and the man or woman drugs to be imported. The programs may be made by using legal agents of overseas corporations in India. The documents required for registration certificates were in reality distinctive in the amendments. The validity of registration certificates will be three years from the date on which those are issued.
Operon Strategist is best medical device consulting. They can assists medical device distributors and medical device wholesalers in India to procure CDSCO import license. An Import license is issued for import of medical device from other country to India. Both the foreign company and Indian company jointly needs to submit the documentation for medical device and manufacturing unit.
Medical Device Import License:
Applicable when we have to import medical devices from other countries to India. However they need to be classified according to CDSCO notified devices list. CDSCO has complete procedure for granting license for medical device imported in the countries.
Application for grant of import license for medical device
- 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.
- 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.
- Looking to register medical device in India ? Lets get CDSCO import license now.Operon Strategist is a medical device consulting company they will help.
- 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.
- 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.
More Article – https://www.nativesdaily.com/fda-510-k-submission-premarket-approval/
