CDSCO REGISTRATION FOR MEDICAL DEVICES

CDSCO Registration - Overview

The Central Drugs Standard Control Organization (CDSCO) is India’s main regulatory body responsible for overseeing the registration, approval, and quality control of pharmaceuticals, medical devices, and other health-related products. For any product that impacts health, CDSCO registration is mandatory. This registration process ensures that all health products meet strict standards for quality, safety, and effectiveness.

Importance of CDSCO Registration

CDSCO registration is crucial for manufacturers and importers aiming to sell health-related products in India. The rigorous approval process ensures that only safe and high-quality medical devices and pharmaceuticals reach the market, which is essential for public health protection. CDSCO registration is also commonly referred to as market authorization or product licensing, as it grants legal clearance to market a product in India.

CDSCO offers different certifications depending on the type of product and its intended use. The main certifications include:

Each type of CDSCO certification has specific regulatory requirements and approval processes. Applicants must identify the applicable certification category to ensure timely and compliant market access.

To manufacture a medical device in India, a CDSCO Manufacturing License is essential. The licensing requirements are based on device classification:

Manufacturers must apply to the appropriate licensing authority based on the classification of their medical device, as per CDSCO guidelines.

CDSCO Import License Registration for Medical Devices

For companies looking to import medical devices into India, a CDSCO Import License is mandatory. The requirements are structured around the medical device’s classification:

CDSCO classifies medical devices based on their intended use and the level of risk associated with them. This classification determines the regulatory pathway and the extent of regulatory scrutiny:

This classification framework helps determine the applicable licensing authority, documentation requirements, and level of regulatory control for each medical device category.

In October 2023, CDSCO announced mandatory registration for all medical devices for import and sale in India. The new rule covers Class C and D devices registered before this date, with a grace period of six months for these classes.

In addition to CDSCO registration, the Bureau of Indian Standards (BIS) certification is required for certain medical devices to guarantee quality and performance standards. BIS certification is essential for manufacturers who intend to sell their products in India and requires rigorous testing. Some products may need in-country testing to meet BIS standards, and all Class A and B devices also need an Import License if manufactured overseas.

CDSCO registration is a critical requirement for anyone seeking to introduce health-related products into India’s market. It ensures that only safe, effective, and high-quality products are available to Indian consumers. With recent regulatory updates, such as the mandatory registration of all medical devices, CDSCO is expanding its role in promoting public health and safety. By following the outlined steps and understanding the requirements, manufacturers and importers can navigate the CDSCO registration process more effectively and establish a strong presence in India’s rapidly growing healthcare market.