CDSCO India Medical Device Registration
India, with a population exceeding 1.3 billion, is one of the largest and fastest-growing healthcare markets globally. The demand for medical devices is booming, driven by an expanding healthcare infrastructure, rising health awareness, and increasing access to medical treatments. A significant portion of medical devices in the Indian market are imported, presenting substantial opportunities for foreign manufacturers.
Complying with India's CDSCO Regulations
Regulatory Authority
Pure Global can assist with India's medical device registration, ensuring CDSCO approval to sell in the Indian market.
Classification
India classifies medical devices into four classes (A, B, C, and D) based on their risk profile, from low to high risk. This classification guides the regulatory process, with higher-risk devices undergoing more stringent evaluation.
Key Requirements
To introduce medical devices into the Indian market, manufacturers must:
- Obtain a registration certificate and import license from the CDSCO.
- Ensure compliance with the Indian Medical Device Rules (MDR), 2017, for product testing, quality certification, and post-market surveillance.
- Foreign manufacturers without a legal entity in India must appoint an Authorized Indian Agent to liaise with the CDSCO and manage regulatory submissions.
Tailored Support for Market Entry
Our services simplify your entry into India's medical device market:
Assistance with product classification and determination of the regulatory pathway.
Support in compiling the necessary documentation for CDSCO registration and import licensing.
Acting as your Authorized Indian Agent, handling regulatory submissions, and ensuring ongoing compliance with Indian regulations.
We Provide Access To 28+ Markets Worldwide
Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.