Regulated Medical Device

Regulated Medical Device

Date : 2022-03-07


As per the Gazette Notifications GSR 102 (dated 11 Feb 2020), a list of 37 medical devices specified in the Annexure of Eighth Schedule of MDR 2017 falls under the category of Regulated Medical Devices, which are as follow:
1. Disposable Hypodermic Syringes
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2. Disposable Hypodermic Needles
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3. Disposable Perfusion Sets
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4. Substances used for in vitro diagnosis including Blood Grouping Sera
5. Cardiac Stents
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6. Drug Eluting Stents
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7. Catheters
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8. Intra Ocular Lenses
 
image-20210925-094217-min
 
9. I.V. Cannulae
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10. Bone Cements
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11. Heart Valves
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12. Scalp Vein Set
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13. Orthopedic Implants
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14. Internal Prosthetic Replacements
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15. Ablation Devices
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16. Ligatures, Sutures and Staplers
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17. Intra Uterine Devices (Cu-T)
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18. Condoms
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19. Tubal Rings
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20. Surgical Dressings
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21. Umbilical tapes
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22. Blood/Blood Component Bags
 
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23. Organ Preservative Solution*
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24. Nebulizer
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25. Blood Pressure Monitoring Device
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Author : Medical Device Registration