Medical Device Regulation 2017 India

New medical devices rules india 2017 key features for regulatory approvals and registrations.

Medical device regulation 2017 india.

This process stood until 2017 when the medical device regulation. 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. 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. 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 necessary for regulatory approval impact of the medical device and ivd sector. The suggested medical device rules and regulatory updates has several measures to streamline the current standards in the medical device and ivd sector. Regulation of medical device covered under notified medical device.

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. India medical device regulations all documents listed below were published by the ministry of health and family welfare mhfw and are in pdf format. These rules shall be applicable to. Definition of a medical device or are covered by this regulation.

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. Regulatory and guidance documents referring to its requirements are available here. These rules shall unless specified otherwise come into force with effect from 1st day of january 2018. 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.

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