CDSCO India Medical Device Registration & Approval
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 following CDSCO India medical device registration and approval, presenting substantial opportunities for foreign manufacturers.
Complying with India's CDSCO Regulations
Regulatory Authority
Medical devices sold in India are regulated by the The Central Drugs Standard Control Organization (CDSCO). Pure Global can assist with India's medical device registration and local representation, 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.
Frequently
Asked Questions
What is the primary regulatory authority for medical device registration in India?
The primary regulatory authority for medical device registration in India is the Central Drugs Standard Control Organization (CDSCO). Pure Global can assist with navigating the registration process to ensure CDSCO approval for selling medical devices in the Indian market.
How are medical devices classified in India?
Medical devices in India are classified into four classes (A, B, C, and D) based on their risk profile, ranging from low to high risk. This classification, under the Central Drugs Standard Control Organisation, determines the regulatory pathway and the level of scrutiny required for registration and market entry.
What are the key requirements for foreign manufacturers to market medical devices in India?
Foreign manufacturers must: Obtain a registration certificate and import license from the CDSCO for their medical devices to ensure proper CDSCO registration. Ensure compliance with the Indian Medical Device Rules (MDR), 2017, which includes requirements for product testing, quality certification, and post-market surveillance. Appoint an Authorized Indian Agent if they do not have a legal entity in India. The Authorized Indian Agent liaises with the CDSCO on behalf of the manufacturer and manages all regulatory submissions.
Why is appointing an Authorized Indian Agent important for foreign manufacturers?
Appointing an Authorized Indian Agent is crucial because the agent acts as the local representative of the foreign manufacturer in India. The Authorized Indian Agent facilitates communication with the CDSCO, ensures compliance with Indian regulations, and manages regulatory processes, including submissions and approvals. This enables foreign manufacturers to successfully navigate the regulatory landscape and enter the India medical device market.
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.