OnlyBizBasics
Healthcare & MedTech · India
Enter and scale in India's medical device & MedTech market.
CDSCO licensing, device classification, SaMD compliance and India launch — turned into a clear, costed pathway.
OnlyBizBasics is an India-focused advisory that helps MedTech companies get medical devices classified, licensed by CDSCO, and launched in India.
What we help with
Healthcare & MedTech services
We own the regulatory-and-go-to-market pathway so your team can focus on the product.
- CDSCO registration & licensing — Import and manufacturing licences, agent representation.
- Device classification & strategy — Risk class, predicate analysis, regulatory roadmap.
- SaMD regulatory compliance — Software-as-a-medical-device classification and filing.
- Clinical & BA/BE strategy — Evidence planning, study oversight, dossier support.
- India market entry & launch — Distribution, pricing, post-market and go-to-market.
Start the conversation
Tell us your Healthcare & MedTech goal in India.
Bring your objective and timeline, and leave with a clear view of the regulatory route, the effort and the first steps — before any commitment.
Questions, answered
Healthcare & MedTech FAQ
Which regulator approves medical devices in India?+
CDSCO is Indias national medical device regulator, working with State Licensing Authorities under the Medical Device Rules, 2017.
How do you register a medical device in India?+
Classify the device by risk (Class A to D), assemble the technical file, and apply to CDSCO. For imports this runs through an authorised agent via Form MD-14 leading to an MD-15 licence.
Do software medical devices (SaMD) need approval?+
Yes. SaMD is regulated under the Medical Device Rules, 2017 when its intended use meets the medical-device definition.
How do we start?+
Book a consultation and we map the classification, licence route and effort for your device.
Begin
Ready to move on Healthcare & MedTech in India?
Book a consultation and we will map your pathway before any commitment.