The Indian Government may soon make it mandatory for medical devices such as stents,catheters,orthopedic implants and heart valves to obtain quality certifications before they reaches Indian medical device market.Products from both domestic and multinational medica device manufacturers must pass quality tests from standardizing bodies such as Bureau Of Indian Standards (BIS) or global quality solution provider Intertek
Leading players of medical device manufacturers such as siemens,Philips,GE and LG.India has a $2 billion medical device industry.The health ministry has asked Drug Controller General Of India (DCGI) to check marketing of forged and poor quality products.”The regulatory guidelines are ready and will be summitted it to the DTAB by the end of December for approvals.These guidelines would cover the definition,classification,certification and quality standards of medical devices.Whereas the standards are meant to test and verify medical devices,the classification will be in terms of risk associated with these devices.
The notified agencies would certify medical devices after auditing the quality,infrastructure,manpower and manufacturing plants of the company.The idea thus conceived to ensure access to safe,effective and clinically beneficial medical technologies for patients across the country
Certain medical devices are as important as life saving drugs;”There are devices which are implanted into human body for critical care.If not regulated patients may fall victim to poor quality medical devices.
Leading players of medical device manufacturers such as siemens,Philips,GE and LG.India has a $2 billion medical device industry.The health ministry has asked Drug Controller General Of India (DCGI) to check marketing of forged and poor quality products.”The regulatory guidelines are ready and will be summitted it to the DTAB by the end of December for approvals.These guidelines would cover the definition,classification,certification and quality standards of medical devices.Whereas the standards are meant to test and verify medical devices,the classification will be in terms of risk associated with these devices.
The notified agencies would certify medical devices after auditing the quality,infrastructure,manpower and manufacturing plants of the company.The idea thus conceived to ensure access to safe,effective and clinically beneficial medical technologies for patients across the country
Certain medical devices are as important as life saving drugs;”There are devices which are implanted into human body for critical care.If not regulated patients may fall victim to poor quality medical devices.
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