Govt is 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.Apart from catheters, stents and orthopaedic implants, the list also includes heart valves, intra-ocular lenses, syringes and needles.
what is a drug?
The material or 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.
what is the benefit by bringing "medical devices" under drugs category?
It bring them automatically under price regulation as like drugs.
how the medical devices classified?
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.
Hope, from 2018,its going to change for better!
The government has also notified 15 devices as drugs bring them automatically under price regulation.Apart from catheters, stents and orthopaedic implants, the list also includes heart valves, intra-ocular lenses, syringes and needles.
what is a drug?
The material or 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.
what is the benefit by bringing "medical devices" under drugs category?
It bring them automatically under price regulation as like drugs.
how the medical devices classified?
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.
Hope, from 2018,its going to change for better!
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