Medical Devices
Medical Device Licenses
We are providing end-to-end regulatory services for
Medical Device importers, manufacturers and
supplies. Our team is experienced for swift
regulatory submissions and approvals.
Complex Medical Device Regulations make registrations more Expensive
Navigating the Indian medical device market poses substantial challenges due to its intricate and time-intensive registration process. This complexity affects importers, traders, manufacturers, and multinational corporations alike, hindering their entry and growth in this high-potential sector. As India's regulatory framework continually evolves, our expertise is dedicated to streamlining and optimizing your regulatory strategy, ensuring smoother market access and compliance.
The following entities are allowed as distributors (corporate sellers) of Insurance, as of now.
- Import License or Registration of Medical Devices (MD 14)
- Manufacturing License (MD 5)
- Registration of an Innovative/New Medical Device (MD 26)
- Post approval changes
- ISO 13485 from DCGI’s notified agencies
- Clinical Trial Approvals
- Import Test License (MD 16)
- In-Vitro Diagnostic Products/Kits