Government notifies 15 medical devices as drugs for price re
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
The health ministry has notified Medical Devices Rules, 2017, which will come into effect from January 2018 and has also notified 15 devices as drugs bring them automatically under price regulation. The 15 devices are:
1. Disposable Hypodermic Syringes
2. Disposable Hypodermic Needles
3. Disposable Perfusion Sets
4. In vitro Diagnostic Devices for HIV, HbsAg and HCV
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. Orthopedic Implants
14. Internal Prosthetic Replacements
15. Ablation Device

To be classified as a drug, devices must be intended for internal or external use in 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 govt by notification in the Official Gazette, after consultation with the Board. The rules classify medical devices into four categories - A, B, C, and D on the basis of the level of risk and the use of the device. For instance, implantable devices such as stents will be part of the high risk category and monitored directly by the government regulator. Medium and low risk devices will be regulated by state drug authorities and quality monitoring agencies such as Bureau of Indian Standards.


http://bit.ly/2sOXoHP
Dr. A●●l P●●●●h and 8 others like this7 shares
Like
Comment
Share