Registration support for Medical Devices and IVDs
India Medical Device Registration
Navigating the Medical Device Rules 2017 and the Medical Devices (Amendment) Rules 2020 is essential for ensuring regulatory compliance in India.
Qserve offers expert support for India Medical Device Registration, covering both medical devices and in vitro diagnostic devices (IVDs). We assist manufacturers in registering their products and maintaining compliance within the Central Drugs Standard Control Organization (CDSCO) database, the authoritative body overseeing medical device registration in India.
By partnering with Qserve, you can streamline the registration process and focus on successfully entering the Indian market while we handle regulatory requirements efficiently.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
Do you need assistance with the India Medical Device Registration requirements or go-to-market strategy?
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Regulatory Compliance in India
India Medical Device Registration support
India offers significant potential for medical device manufacturers. To enter this promising market, rely on Qserve’s India Medical Device Registration support.
Our team of in-house experts across multiple time zones ensures seamless support tailored to your needs. We analyze your existing technical documentation, compare it to India’s regulatory requirements, and identify potential gaps. With a clear understanding of the India Medical Device Regulations, we collaborate to create a strategic compliance plan. Already have a strategy? We provide hands-on support to prepare and submit your documentation, ensuring a smooth process with the Central Drug s Standard Control Organization (CDSCO).
Why Choose Qserve?
Global support, local presence
Qserve combines globexpertise with local insights to provide exceptional regulatory and quality affairs services for medical devices and in vitro diagnostics (IVDs).
Market Access Expertise
As a leading regulatory consulting firm, Qserve helps clients achieve and maintain market access worldwide.
Experienced Team
Our team of regulatory and quality experts has extensive experience navigating complex regulatory landscapes, ensuring compliance with India’s unique requirements.
Practical Approach
We guide you step by step, providing practical solutions for regulatory challenges and ensuring efficient market entry.