Medical Device Regulation 2017 India

The indian health ministry s newly released draft of medical device regulation in 2016 called the medical device rules 2016 has taken note of the separate laws of registration for all medical devices in vitro diagnostic ivd products.

Medical device regulation 2017 india.

Regulations for the manufacture sale or distribution of medical devices are now based on these classifications and are proportionate to the level of risk associated with the medical device. The suggested medical device rules necessary for regulatory approval impact of the medical device and ivd sector. The ministry of health and family welfare imposed the medical device rules in january 2018. The government has notified medical devices rules 2017 on 31 01 2017 and it will come into force on january 1 2018.

The suggested medical device rules and regulatory updates has several measures to streamline the current standards in the medical device and ivd sector. Non compliance observed during review process of application for registration import. These rules shall be applicable to. Regulation of medical device covered under notified medical device.

Hence government of india has issued a draft of medical devices to help the medical device industry and will separate the regulatory norms for manufacturing of medical devices from drugs. In fact in the past manufacturers interested in registering their medical devices in india just had to supply proof of approval in their home country s market to the indian medical device regulatory body the central drugs standard control organization and an import license. These rules shall unless specified otherwise come into force with effect from 1st day of january 2018. 12 cer tain groups of products for which a manufacturer claims only an aesthetic or another non medical pur pose but which are similar to medical devices in terms of functioning and r isks profile should be covered by this regulation.

Report of the committee to examine the issues relating to the essentiality of coronary stents. Regulatory and guidance documents referring to its requirements are available here. Under the medical devices rules 2017 regulations for classes a and b are broadly similar while classes c and d also enjoy some regulatory parity. India medical device regulations all documents listed below were published by the ministry of health and family welfare mhfw and are in pdf format.

In february india s ministry of health and family welfare released its medical device rules 2017 a 142 page document that lays out all of the details of the regulations that are now being. The draft of medical device was issued on january 31 2017 and came into force on january 31 2018. Definition of a medical device or are covered by this regulation.