Such devices intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.
Medical Device & Diagnostics Division, Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002, is responsible for registration/import of Medical Devices in India.
For the import of medical devices in India, the Registration Certificate in Form 41 and Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules.
For the import of medical devices, the manufacturing site and products (medical devices) are required to be registered with Indian drug regulatory agencies (i.e. Central Drugs Standards Control Organization).
The requirements for Re-registration of Devices are remained same as fresh Registration requirements except the requirement of hard copy of Plant Master File (PMF) and Device Master File (DMF) provided there are no changes in the PMF and DMF, However soft copy of PMF and DMF in the form of the compact disc shall be provided along with the application.
Yes, an applicant can apply for both Registration Certificate (Form 41) and Import License (Form 10) together, provided Indian agent and importer remain same.
A fee of three hundred US dollars [or its equivalent in Indian rupees] shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.
The requirements for grant of import license in Form 10 are available in the CDSCO web page under link:http://cdsco.nic.in/Medical_div/medical_device_division.htm
Import License, unless, it is sooner suspended or cancelled, shall be valid for a period of three years (Till Registration Certificate is valid).