The Union health ministry of India has newly released a draft for Medical devices rules on 17 Oct, 2016 in Gazette notification and opened a 30-day comment period through which industry and other interested persons may submit feedback regarding the new proposals.

• These rules may be called “The Medical device rules 2016”

• The government will consider the comment on proposed regulatory changes received from any person within 30 days (until mid of November 2016)

• Draft rules would create separate law for registration and a new system designed especially for all medical devices and In vitro diagnostic products

Following the comment period and review of industry and other interested person feedback, the government of India will finalize the draft regulations and no specified period for such a move have been provided. India is one of the largest markets in Asia and it continues to grow rapidly. To stimulate this growth Central Drugs Standard Control Organization (CDSCO) has proposed several initiatives and changes.