C | M | S

Compliance | Management | Solutions

Medical Device Registration in India: CDSCO and In-Country Representation

India's healthcare landscape is expanding rapidly, which makes it one of the more promising markets for medical device manufacturers. With a population above 1.4 billion and a healthcare market projected to reach USD 50 billion by 2030, the opportunity is significant.

Why manufacturers are looking at India

  • A market projected to exceed USD 50 billion by 2030
  • Growth above 15 percent CAGR, among the fastest globally
  • An expanding private healthcare sector and rapid hospital growth
  • Rising demand for quality imported devices across imaging, surgery, diagnostics, cardiology, orthopaedics and home care

What entering the market actually requires

Successful entry requires more than exporting. It requires local insight, regulatory expertise and considered positioning. Compliance Management Solutions provides:

  • CDSCO regulatory strategy and device registration
  • Navigation of the Indian Medical Device Rules
  • In-country representation for legal, technical and commercial compliance
  • Support with clinical evaluation, labelling, post-market surveillance and vigilance

We work across Class A to Class D devices. To discuss entry into the Indian market, please contact our regulatory team.

Talk to our regulatory team ← All news

Call now Email