You've developed a groundbreaking medical device a true innovation with no existing equivalent on the market. Congratulations! But how do you get it approved in India? The Medical Devices Rules, 2017, have a specific pathway for such novel devices, often called devices "without a predicate."
1. Understanding the "Predicate Device" Concept
A predicate device is a legally marketed device, already approved by the Central Licensing Authority (CLA), that has a similar intended use and design characteristics as a new device. Most regulatory approvals rely on demonstrating "substantial equivalence" to a predicate. But when your device is the first of its kind, this path isn't available.
2. The Pathway for Novel Devices: Chapter VIII
Chapter VIII of the rules is dedicated to devices that do not have a predicate. The process acknowledges that these devices require a more thorough evaluation of their safety and effectiveness from the ground up.
The first step is completing a full clinical investigation in India as per the requirements of Chapter VII. This means conducting both pilot and pivotal studies to generate robust local data on the device's performance and safety in the Indian population.
3. Applying for Permission: Form MD-26
After completing your clinical investigation, you must apply to the CLA for permission to manufacture or import the device using Form MD-26. This application must be supported by a comprehensive data package, including:
• Design Analysis Data: Detailed documentation on the device's design inputs, outputs, and validation.
• Bio-compatibility and Animal Study Data: Evidence that the materials are safe and that the device performs as expected in pre-clinical models.
• Risk Management Data: A thorough risk analysis and documentation of how all identified risks have been mitigated.
• Complete Clinical Investigation Report: The full results from your Indian clinical studies.
4. Are There Waivers or Abbreviated Pathways?
Yes, but only in specific, high-need situations. The rules allow the CLA to abbreviate, defer, or waive the clinical data requirements for devices intended for:
• Life-threatening or serious diseases.
• Conditions with no existing therapy.
• Use in national emergencies or epidemics.
Additionally, if your device has been approved and marketed for at least two years in the UK, USA, Australia, Canada, or Japan, and there's no evidence of different performance in the Indian population, you may be able to submit that data in lieu of a local trial, provided you commit to a post-marketing clinical investigation.
5. Post-Approval Commitments
If your innovative device is approved (via Form MD-27), your responsibilities don't end. You must submit Periodic Safety Update Reports (PSURs) to the CLA every six months for the first two years, and then annually for the next two years, to continuously monitor its real-world safety and performance.
This pathway, while demanding, provides a clear roadmap for bringing true medical innovation to patients in India safely and effectively.
At Satori One Click Solution LLP, we specialize in guiding innovators, startups, and global manufacturers through India’s regulatory landscape—be it predicate devices, novel devices under Chapter VIII, or global submissions aligned with USFDA, CDSCO, Health Canada, and EMA requirements.
👉 If you’re building the next big thing in medical technology, let’s connect and make sure your innovation reaches patients smoothly and compliantly.
Email: satoriocs@gmail.com