Medical Device Regulation 2017 India

The draft of medical device was issued on january 31 2017 and came into force on january 31 2018.

Medical device regulation 2017 india.

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. 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. Regulation of medical device covered under notified medical device. New medical devices rules india 2017 key features for regulatory approvals and registrations.

These rules shall be applicable to. 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 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.

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. Regulatory and guidance documents referring to its requirements are available here. Report of the committee to examine the issues relating to the essentiality of coronary stents.

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. This process stood until 2017 when the medical device regulation. India medical device regulations all documents listed below were published by the ministry of health and family welfare mhfw and are in pdf format. Definition of a medical device or are covered by this regulation.

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. Non compliance observed during review process of application for registration import. Medical device rules 2017 new medical device rules 2017 have been published by government of india via gazette notification gsr 78 e on 31st january 2017.