Registration support for Medical Devices and IVDs
India Medical Device Registration
Achieving regulatory compliance with the Medical Device Rules 2017 and the newly introduced Medical Devices (Amendment) Rules 2020.
Qserve can support you with the India Medical Device Registration for medical devices and IVDs and maintenance of registered products in the Central Drugs Standard Control Organization (CDSCO) database, which is the authority responsible for medical device registration.
Regulatory Compliance in India
India Medical Device Registration support
With India being a great potential market, consider selling your medical devices in India. Qserve has several in-house experts based in different time zones who can help you prepare your documentation. Our experts compare your existing technical documentation to the India Medical Device Registration and regulatory requirements and can identify possible gaps. We know the requirements and can set up a strategy plan together. Already know your strategy? We provide hands-on support to prepare your submission file and ensure a smooth process with the competent authority.
Benefits of Qserve engagement
Global support, local presence
- Qserve is a leading regulatory consulting firm offering medical devices and in vitro diagnostic regulatory and quality affairs services.
- We specialize in helping clients achieve and maintain market access around the world.
- Our team of experienced regulatory and quality experts have a deep understanding of the regulatory landscape and can help manufacturers navigate the complex requirements.
- Qserve uses a practical approach to support you every step of the way.