Need of medical device regulations in India / Importance of Medical device registration in India.

1. CliniExperts Pvt. Ltd. Need of medical device regulations in India / Importance of Medical device registration in India. The Medical Device industry has constant demand/appeal 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: Devices that are intended for both internal and external use in disease, diagnosis, treatment and prevention in animals as well as human beings. 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. Things that are used in vitro diagnosis. Any things that are used for diagnosis, treatment, mitigation and prevention of any kind of disease.Classification of medical devices: There are four different type of medical device based on their risk type.: Class A medical device – this includes all low-risk devices. Class B medical device: This is devices that are of low moderate risk. Class C – Medical devices that are of moderate-high risk. Class D – High-risk devices. Class D – 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.

2. Product values for medical devices – Bureau of Indian Standards (BIS), International Organization for Standardization (ISO), International Electro-Technical Commission (IEC), any other pharmacopoeia standards, validated manufacturer's standards can also be used. Time rationalization is highly important for getting a license. Under 2017 those licenses are given are perpetual. New threshold for the residual shelf life of imported products has been set Kommentar [BM1]: Not clear How to Get Medical Device Registration India? All medical devices, 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. Kommentar [BM2]: If we add the exempted list this statement would be meaningful https://cliniexperts.com Unit No. 325, City Centre Mall Email: contact@cliniexperts.com Tel : + 91 - 11 –28081765 Plot No. 5, Sector 12 Tower Dwarka New Delhi- 110075