Navigating India's Medical Device Regulatory Framework

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.

Device Classification and Regulatory Pathways

Complying with India's CDSCO Regulations

Regulatory Authority

The Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health & Family Welfare regulates medical devices in India. Recent regulatory updates aim to streamline the approval process and ensure medical devices meet safety and efficacy standards. Manufacturers must navigate India's regulatory landscape, which includes registration, licensing, and compliance with quality standards.

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.
How We Can Help

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.

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