Regulatory Approval of Medical Devices in India – Inhouse Training

Successful Medical Device Registration in India

Registering medical devices in India is a crucial step toward gaining access to the growing Indian healthcare market. India has an independent, increasingly stringent regulatory system that requires careful preparation and a thorough understanding of the regulations. Successful registration can also serve as a gateway to accessing other markets in South Asia.

In India, the Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), is responsible for regulating medical devices. Medical devices are classified into four risk classes (A, B, C, D) in accordance with the Medical Device Rules (MDR), 2017.

All products that fall under the definition of a medical device must be either registered or approved, depending on their class. International manufacturers require an authorized Indian importer or local representative who is listed with the CDSCO.

Certain products are subject to additional requirements, such as certification by the Bureau of Indian Standards (BIS) or registration with the Atomic Energy Regulatory Board (AERB).

What Sets Our Seminar Apart

In this interactive seminar, you will learn about the regulatory requirements for the approval of medical devices in India.

Using real-world examples, we will show you how to classify your products correctly, compile the necessary documentation, and successfully navigate the registration and approval process.