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The Medical Device industry has constant demandappeal to the government to separate them from the pharma industry so that there will be a separate law for regulating the Medical Device and the Pharma Sctors. . This constant demand led to the creation of medical device regulations by the Government of India.
What is a medical device according to Medical device rules?
Medical
devices include:
鈥?Devices that are intended for both internal and external use in
disease [url=http://www.fcbayernmunchenshop.de/rafinha-trikot-bayern.html]Rafinha
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well as human beings.
鈥?Specific things that are intended to have an effect
on the structure or function of the human body under government notification.
Example: disinfectants, mechanical contraceptives.
鈥?Things that are used in
vitro diagnosis.
Any things that are used for
diagnosis [url=http://www.fcbayernmunchenshop.de/...z-trikot-bayern.html]James
Rodriguez Trikot Bayern München[/url] , treatment, mitigation and prevention of
any kind of sification of medical devices:
There are four different type of
medical device based on their risk type.:
鈥?Class A medical device 鈥?this includes all low-risk devices.
鈥?Class B
medical device: This is devices that are of low moderate risk.
鈥?Class C
鈥?Medical devices that are of moderate-high risk.
鈥?Class D 鈥?High-risk
devices.
鈥?Class D 鈥?High-Risk Devices
Who is the assessment authority for medical device registration?
Assessment authority is based on the class of medical device the . All the applications for Class A or Class B medical devices are assessed by State Licensing authority. The Central Licensing Authority controls the process and application for Class C and Class D manufacturer.
Now let's have a look at some of the important features of new medical device regulation India.
The process involves single window clearance and single online portal.
鈥?Product values for medical devices 鈥?Bureau of Indian Standards (BIS),
International Organization for Standardization
(ISO) [url=http://www.fcbayernmunchenshop.de/...n-trikot-bayern.html]Arjen
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(IEC), any other pharmacopoeia standards, validated manufactu
