Medical device registration in India CDSCO

CMC Medical Devices offers registration of medical devices in India and access to the regulatory market

We facilitate registration of medical devices in India, ensuring that your product complies with all CDSCO regulatory requirements for efficient and compliant access to the Indian market.

Regulation of medical devices in india

The manufacturer must designate an authorized Indian agent for the registration process.

The registration timelines are between 6 to 9 months for all medical devices. A detailed technical dossier is required for the registration process in India. Manufacturers with an approval of origin (FDA or CE) can use it to leverage the registration of their devices in India. The registration certificate is valid for a period of 3 years and must be reapplied for within 6 to 9 months prior to its expiration date.

CMC can assist you in entering the Indian market by registering your products with the CDSCO.

Select CMC as your medical device regulatory consultants in india

Complete the contact form and one of our consultants will get in touch as soon as possible.

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Frequently asked questions about india medical device regulations

Is CDSCO registration mandatory for foreign companies?

Yes, foreign companies intending to market drugs or medical devices in India must obtain registration and approval from CDSCO to ensure compliance with Indian regulations.

What types of products are regulated by CDSCO?

CDSCO regulates pharmaceuticals, medical devices, cosmetics, and clinical trials. This includes both new and generic drugs, as well as over-the-counter and prescription medications.

What are the requirements for obtaining CDSCO approval?

Requirements typically include submitting a comprehensive application, providing data on product safety and efficacy, and complying with Good Manufacturing Practices (GMP). Specific requirements can vary depending on the type of product.

How long does the CDSCO approval process take?

The approval timeline can vary significantly based on the product type and completeness of the application. Generally, the process can take anywhere from a few months to over a year.

Why appoint CMC Medical Devices as your medical device registration in india?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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