Medical Devices – CDSCO Approvals

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Medical Devices Approvals from The Central Drugs Standard Control Organisation (CDSCO)

The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. Its’ headquarter is located at New Delhi and operates through six zonal offices, four sub zonal offices, thirteen Port offices and seven laboratories spread across the country.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

CDSCO handles licensing for Manufacture / Imports of Class A, B C and D devices. It also provides licenses for Clinical Investigation[/vc_column_text][vc_text_separator title=”WHO CAN APPLY?” i_icon_fontawesome=”fa fa-users” title_align=”separator_align_left” add_icon=”true” css=”.vc_custom_1588500252571{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 10px !important;}”][vc_column_text]Indian Manufacturers or Manufacturers Abroad with established Authorised Indian (Local) Representative (ALR) could apply for License from CDSCO.[/vc_column_text][vc_text_separator title=”REQUIREMENT FOR MEDICAL DEVICES CDSCO APPROVALS” i_icon_fontawesome=”fa fa-book” i_color=”juicy_pink” title_align=”separator_align_left” add_icon=”true” css=”.vc_custom_1589011348784{margin-bottom: 0px !important;border-bottom-width: 0px !important;padding-bottom: 10px !important;}”][vc_column_text css=”.vc_custom_1589469811314{margin-top: 0px !important;border-top-width: 0px !important;padding-top: 0px !important;}”]

Requirements for Approval

  • Selected Medical devices shall be registered with the Central Licensing Authority
  • The registration is on voluntary basis for a period of eighteen months wef 1.4.2020 there after it shall be mandatory
  • The manufacturer of a medical device shall provide the information for registration covering
    1. legal entity details
    2. Details of medical device Generic Name, Model, Intended Use Class, Material, Dimension, Shelf Life, Sterile or Non-Sterile, Brand Name etc.
    3. Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies (NABCB) or International Accreditation Forum (IAF) in respect of such medical device.
    4. Undertaking duly signed by the manufacturer
    5. Registration number so generated, shall be mentioned on the label of the medical device
  • The importer shall provide the following information for registration
    1. Legal entity importing with specification and standards of the device
    2. Details of medical device Generic Name, Model, Intended Use Class, Material, Dimension, Shelf Life, Sterile or Non-Sterile, Brand Name etc.
    3. Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies (NABCB) or International Accreditation Forum (IAF) in respect of such medical device.
    4. Free sale certificate from country of origin.
    5. Undertaking duly signed by the importer
    6. Registration number so generated, shall be mentioned on the label of the medical device

Schedule for Mandating Registration

    1. Disposable Hypodermic Syringes
    2. Disposable Hypodermic Needles
    3. Disposable Perfusion Sets
    4. Substances used for in vitro diagnosis including Blood Grouping Sera
    5. Cardiac Stents
    6. Drug Eluting Stents
    7. Catheters
    8. Intra Ocular Lenses
    9. I.V. Cannulas
    10. Bone Cements
    11. Heart Valves
    12. Scalp Vein Set
    13. Orthopaedic Implants
    14. Internal Prosthetic Replacements
    15. Ablation Devices
    16. Ligatures, Sutures and Staplers
    17. Intra Uterine Devices (Cu-T)
    18. Condoms
    19. Tubal Rings
    20. Surgical Dressings
    21. Umbilical tapes
    22. Blood/Blood Component Bags
    23. Organ Preservative Solution*
    24. Nebulizer (effective from 1 Jan.2021)
    25. Blood Pressure Monitoring Device (effective from 1 Jan.2021)
    26. Glucometer (effective from 1 Jan.2021)
    27. Digital Thermometer (effective from 1 Jan.2021)
    28. All implantable medical devices Equipment (effective from 1, April,2021)
    29. CT Scan Equipment (effective from 1, April,2021)
    30. MRI Equipment (effective from 1, April,2021)
    31. Defibrillators (effective from 1, April,2021)
    32. PET Equipment (effective from 1, April,2021)
    33. X-Ray Machine (effective from 1, April,2021)
    34. Dialysis Machine (effective from 1, April,2021)
    35. Bone marrow cell separator (effective from 1, April,2021)
    36. Disinfectants and insecticide specified in Medical Devices Rules, 2017
    37. Ultrasound equipment (effective from 1, November, 2020)

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