INTRODUCTION

Medical Devices

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.

Approval for Medical devices
DOCUMENT REQUIRED

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).

PROCEDURE
01.

Pay the required Registration fee through TR-6 Challan (in triplicate) in Bank of Baroda, Kasturba Gandhi Marg, New Delhi. A fee of one thousand and five hundred US dollars [or its equivalent in Indian rupees] shall be paid along with the application in Form 40 as registration fee for the manufacturing premises meant for manufacturing of medical device intended for import into and use in India. A fee of one thousand US dollars [or its equivalent in Indian rupees] shall be paid along with the application in Form 40 for the registration of a single medical device meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional medical device.

02.

Compilation of Registration dossier as per the guidance documents available at the link: http://cdsco.nic.in/Medical_div/guidance.htm

03.

Submit Product Registration application at CDSCO (HQ), New Delhi

TIMELINE

If the application is complete in all respects and informations specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate in From 41.
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    FAQs

    What are the requirements for Re-Registration of devices?

    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.

    Is it possible for an applicant to submit their applications for Registration Certificate (Form 41) and Import License (Form 10) together?

    Yes, an applicant can apply for both Registration Certificate (Form 41) and Import License (Form 10) together, provided Indian agent and importer remain same.

    How much fees for issuance of duplicate copy of “Registration certificate” in Form-41 for Medical Devices in India?

    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.

    What are the requirements for grant of Import license in Form 10 of Medical Devices?

    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

    What is the Duration/Validity of “Import License” in Form-10 for Medical Devices in India?

    Import License, unless, it is sooner suspended or cancelled, shall be valid for a period of three years (Till Registration Certificate is valid).