Navigating Regulatory Challenges for Digital MedTech Products in India
- Indira B N
- Jul 22
- 2 min read
India’s MedTech sector is evolving — not just with hardware, but with AI diagnostics, health monitoring apps, wearable-integrated platforms, and other digital-first innovations.
But here’s the catch: Most of these products don’t fit neatly into traditional regulatory boxes.
As a regulatory affairs consultant, I’m increasingly working with startups and innovators who are asking:
“Is my product a medical device or wellness device?”
“Do I need CDSCO approval for my AI tool?”
“What if my software connects to a CE-marked sensor — does it still need approval in India?”
The answers aren’t always simple — but they are strategic.
India’s current Medical Device Rules (2017) don't yet have specific provisions for AI/ML or SaMD (Software as a Medical Device).
Yet CDSCO is actively reviewing digital health tools that:
Analyze medical images (e.g., fundus scans, X-rays)
Assist diagnosis (e.g., diabetic retinopathy, ECG screening)
Integrate with clinical workflows or influence treatment decisions
If your product provides clinical output, supports diagnosis, or is marketed for medical use — it likely qualifies as a Class B/C device and needs regulatory attention.
My advice to digital MedTech founders:
Get clarity early on device classification — it is crucial and can save you months later, as it dictates the licensing requirements.
Design with compliance in mind — Quality management system is non-negotiable. Apply right standards like ISO 13485, IEC 62304 (for software), and AI lifecycle risk planning.
Cybersecurity & Data Privacy - S
ecure data handling and privacy for patient information is paramount (DPDP Act 2023).
Post-Market Surveillance - monitoring of your product's performance and safety, refere MvPI and plan accordingly.
Engage early with regulators and consultants — don’t wait for the launch to think about compliance.
This is a defining moment. India is innovating rapidly in AI and digital health — let’s make sure our regulatory frameworks keep up with our talent.
Don't let regulatory hurdles slow your innovation. A proactive approach to compliance is key for success in this dynamic landscape.
If you’re building something in this space, I’d love to hear from you. Let’s navigate this together.
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