New Delhi, 06.07.17: Bringing critical medical devices like stents, orthopaedic implants and diagnostic equipment under stringent regulation, the health ministry has notified Medical Devices Rules, 2017, which will come into effect from January, 2018. The government has also notified 15 devices as drugs bring them automatically under price regulation.
” 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,” Drugs Controller General of India (DCGI) GN Singh said in a notice, giving out a list of 15 medical devices notified so far .
Apart from catheters, stents and orthopaedic implants, the list also includes heart valves, intra-ocular lenses, syringes and needles.
The new rules would also require critical devices to undergo trials in India before they are approved for launch. The rules classify medical devices under four categories – A,B,C, and D. The categories are based on the level of risk such as low risk, medium risk and high risk. Standards for regulations will differ based on the use and risk factor. 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. At present, quality checks for medical devices are weak in the absence of specific rules. While ensuring that medical devices sold in India meet standard quality parameters and are affordable, the new rules are also expected to provide industry players a level playing field and ease of doing business.
The Centre has brought medical devices like stents, orthopaedic implants and diagnostic equipment under stringent regulation
Courtesy: Sushmi Dey, The Times of India