On a notice dated June 29, 2017, CDSCO stated that The Drugs & Cosmetics Act, 1940 is an Act to regulate import, manufacture,distribution and sale of drugs and cosmetics. It extends to the whole of India. Further, the Drugs & Cosmetics Rules, 1945 have been put in place which are updated from time to time for uniform implementation of the statutory requirements
The devices 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 official gazette, after consultation with the Board, fall under the definition of drug.
The list of devices, so far are appended includes:
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
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
The notice further informed that the health ministry has notified Medical Devices Rules, 2017, to bringing critical medical devices like stents, orthopaedic implants and diagnostic equipment under stringent regulation,which will come into force with effect from 1st day of January, 2018.
Criteria for Classification of medical devices including in vitro diagnostics have been specified in Rule 4, Chapter II of the rules which deals with regulation of Medical Devices in Indian context and in line with International Classification.
“It is expected that the importers, manufacturers, distributors and supply chain personnel shall voluntarily adhere with the safety, performance and quality aspects as stated in the said medical devices Rule, 2017 for creating proper eco-system for its effective regulation.In order to facilitate the process a special cell has also been created consisting of concerned JDC (I), DDC (I) and ADC (I) to address the issues, if any.” the notice added
A draft list of Medical Devices and in vitro diagnostics along with their risk based classification is annexed. Attached is the notification regarding the same.