11 July 2017
INDIA: Re-designated Medical Devices Now Subject to Drug Price Regulation Regime
Certain medical devices may now be re-classified as drugs at the discretion of the Ministry of Health. All such re-designated devices will then fall within the remit of the Ministry’s price regulation regime and will also be liable to undergo pre-launch clinical trials in compliance with the country’s recently promulgated Medical Devices Rules, due to come into effect as of 1 January 2018.
In the first tranche of re-designations, 15 medical devices have been re-classified – vitro diagnostic devices for HIV, HbsAg and HCV; cardiac stents; drug eluting stents; catheters; intra-ocular lenses; I.V. Cannulae; heart valves; bone cements; scalp vein sets; orthopaedic implants; internal prosthetic replacements; ablation devices; disposable perfusion sets; and disposable hypodermic syringes and needles.