India Medical Device Registration

Qserve is your regulatory consultancy partner for medical device registration services in India.

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. Market Access/Medical Device Registration in India.jpg?preset=content

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. 


Do you need assistance with the India Medical Device Registration requirements or go-to-market strategy?

Qserve is your trusted partner for Indian market access.

Contact us

Market access to India

Do you want to learn more about Indian market access and its regulation?

We help you with a quick overview of:

  • The Indian medical device registration process
  • Classification system
  • Regulatory requirements
  • Registration routes (general or customized to your device)
  • License holding options
  • Important guidance links

Market access India

How Qserve can help

Meet our global registrations team to talk about our services:

  • Regulatory market access strategy
  • Registration support in India
  • Local independent license holding India
  • Technical documentation gap analysis
  • Classification assessment
  • Translation labels and IFUs based on requirements
  • Gap analysis
  • Risk management
  • Clinical evaluation
  • Post-market surveillance
  • Vigilance reporting

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