India Medical Devices Regulations

Medical Device Classification in India

India Medical Device Regulations

India's medical device classification system follows a risk-based approach, aligning with the EU and FDA systems in the US. Medical devices are categorized into four classes based on their risk levels:

• Class A: Low risk
• Class B: Low-moderate risk
• Class C: Moderate-high risk
• Class D: High risk

The Central Licensing Authority (CLA) is responsible for classifying medical devices under the India Medical Device Regulations, governed by the Central Drugs Standard Control Organization (CDSCO). The CDSCO specifies which products are classified as medical devices requiring registration and provides a comprehensive list of device categories.

Manufacturers can self-declare the products of Class A devices. These devices must be registered in the Indian online system, providing details such as:

• Manufacturer's name
• Address
• Product generic name
• Brand name

Similarly, importers must complete the online registration to comply with regulatory requirements.

This streamlined classification and registration process ensures that medical devices meet India's regulatory standards while maintaining safety and quality for end users.

Representation for foreign manufacturers

Appoint an Indian Authorized Agent

Companies must obtain a manufacturing import permit approved by the Central Drugs Standard Control Organization (CDSCO) to distribute medical devices in India legally. The Indian Authorized Agent (IAA) applies for this permit through the online SUGAM portal.

If a company does not have a physical presence in India, it must appoint a local Indian Authorized Agent (IAA). The IAA plays a critical role in ensuring compliance with Indian regulations. Multiple authorized agents can register the same product, offering flexibility for foreign manufacturers. The IAA can be:

• A foreign company’s local office in India
• An independent agency
• An appointed natural person

By appointing an IAA, companies ensure a streamlined registration process and compliance with Indian medical device regulations.