siliconindia | | January 20188IN MY OPINIONontinuing from where we left in part 1, let us look upon the major disruptions which are ex-pected in the medical devices and IVD industry in India due to the new regulation.Medical Devices industry gets regulated for the first time and is expected to create ripples amongst foreign playersFrom January 2018, Indian medical devices, IVD devices and kits sector are expected to feel the impact of the new rule which was passed last year as `The Medical Devic-es Rule 2017'. Till 2017, the medical devices market was largely unregulated (except 10 devices). The MNC medical devices companies could penetrate the Indian market with just an import license. However, this is no longer possible in India.However, the rule is flexible depending on the class of device i.e. a device or IVD with low risk classification will be sparingly regulated, while a device or IVD with high risk classification will be tightly regulated. At present, the Central Regulator has classified 328 medical devices into various risk classes, while the Central Regulator has clas-sified 247 IVDs into various risk classes. From 2018, all IVDs, excepting IVDs for HIV, Hepatitis B and Hepatitis C, (which are presently regulated as drugs), shall be regulated as medical devices only.The new regulation is expected to create a direct im-pact on the P&L of the foreign medical device manufactur-FROM THE DESK OF `FORTUNE TELLERS OF THE HEALTHCARE MARKET' ­ INDIA IN 2018MEDICAL DEVICES & AFFORDABLE HEALTHCAREBy Dr.Siddharth Dutta, Associate Vice President Consulting, MarketsandMarkets Headquartered in Pune, MarketsandMarkets is a global market research and consulting company offering services in the areas of Market Research & Management Consulting, Market Forecasts & Reports, BI, Custom Research Services, and many others. C
< Page 7 | Page 9 >