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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 Greg Gaines Youth Jersey , diagnosis, treatment and prevention in animals as 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 Bobby Evans Youth Jersey , 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) David Long Youth Jersey , International Electro-Technical Commission (IEC), any other pharmacopoeia standards, validated manufacturer's standards can also be used.


鈥?Time rationalization is highly important for getting a license.
鈥?Under 2017 those licenses are given are perpetual.
鈥?New threshold for the residual shelf life of imported products has been set


How to Get ">Medical Device Registration India?


All medical devices Darrell Henderson Youth Jersey , intended for marketing require registration or license . Few are even exempted. Registration of the Medical Device starts with Drug Controller General of India (DCGI) approval process with duly filled application and requisite fee . . If the manufacturer is in abroad and wants to introduce it in the Indian market, then he is required to provide proof of Registration from the home country.
Author Bio: Author is an expert in Indian Drug and Medical device regulation with a keen
interest in tracking and analyzing new regulations.

Total Views: 28Word Count: 429See All articles From Author


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