S.No Name of Notified Medical Devices 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. Cannulae 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…
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Name of Notified Medical Devices
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MEDICAL DEVICES
MEDICAL DEVICES : AN OVERVIEW
CHAPTER I
What is a medical device?
A medical device includes an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, includes a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of―
- diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
- diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
- investigation, replacement or modification or support of the anatomy or of physiological process;
- supporting or sustaining life;
- disinfection of medical devices; and
- control of conception.
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COSMETICS
COMING SOON