What happened
The Union Health Ministry proposed amendments to the Medical Devices Rules, 2017 to make medical device regulation simpler for manufacturers and to help eligible devices reach the market faster. The proposed changes focus on reduced paperwork, standardised testing fees, and expanded pathways that can reduce or waive clinical investigation requirements for eligible devices.
Background and earlier position
Medical device regulation in India operates under the Medical Devices Rules, 2017. For licensing and compliance, the rules cover requirements that manufacturers and other involved facilities must meet. For clinical investigation-related pathways, the Medical Devices Rules, 2017 already allowed reduction or waiver of clinical investigation requirements for eligible devices based on approvals from stringent jurisdictions including the United States, United Kingdom, Australia, Canada, and Japan.
What changed now
The proposed amendments include the following changes: