CDSCO Import License for Class B Medical Devices in India

Medical devices like blood pressure monitors, suction pumps, and infusion sets are categorized as Class B devices under Indian regulations. To import and sell these devices in India, you must obtain a CDSCO Import License.

This license ensures that all imported medical devices meet India’s safety, quality, and performance standards before being used by patients.

What is the CDSCO Import License for Class B Medical Devices in India?

A CDSCO Import License is an official approval granted by the Central Drugs Standard Control Organisation (CDSCO) to import medical devices into India.

For Class B devices, this license confirms that the product is safe, effective, and manufactured in compliance with international quality standards. In simple words, it’s a government permit that allows companies to bring Class B medical devices into India legally.

Why is the CDSCO Import License for Class B Medical Devices in India required?

This license is mandatory because it:

• Ensures only safe and high-quality devices enter the Indian market.
• Protects patients and healthcare users from unsafe products.
• Helps CDSCO track and regulate imported devices.
• Maintains compliance with Medical Device Rules, 2017.

Without this license, importing or selling Class B devices is considered illegal under Indian law.

Which authority issues the CDSCO Import License for Class B Medical Devices in India?

The Central Drugs Standard Control Organisation (CDSCO), operating under the Ministry of Health and Family Welfare, is the authority responsible for issuing the license. The Drugs Controller General of India (DCGI) supervises and approves the final license.

Who can apply for the CDSCO Import License for Class B Medical Devices in India?

The following entities can apply:

• Indian Authorized Agent of a foreign manufacturer (with a valid Import-Export Code).
• Indian Subsidiary of a foreign medical device company.
• Indian Importer or Distributor holding authorization from the manufacturer.
• Regulatory consultants like ELT Corporate, acting on behalf of the applicant.

What is the process to get the CDSCO Import License for Class B Medical Devices in India?

1. Identify the correct device classification (Class B).
2. Appoint an Authorized Indian Agent (for foreign manufacturers).
3. Prepare application in Form MD-14 through the SUGAM Portal.
4. Upload required documents like DMF, PMF, FSC, and labeling details.
5. Pay the applicable government fees online.
6. CDSCO reviews documents and may request clarifications.
7. Once approved, CDSCO issues Import License in Form MD-15.

How long does it take to get the CDSCO Import License for Class B Medical Devices in India?

It generally takes 6 to 9 weeks for CDSCO to review and approve the application, depending on:

• Accuracy of documentation
• Response time to CDSCO queries
• Type of device and its risk level

What is the validity of the CDSCO Import License for Class B Medical Devices in India?

The Import License (Form MD-15) is valid indefinitely, provided that:

• The Retention Fee is paid every 5 years to maintain validity.
• No major changes occur in manufacturing site or device details.

If the manufacturer changes, a new application must be filed.

What are the compliance requirements after getting the CDSCO Import License for Class B Medical Devices?

After receiving the license, the importer must:

• Follow Good Distribution Practices (GDP).
• Maintain records of import, sale, and distribution.
• Report any adverse events or product recalls to CDSCO.
• Keep documents and certificates updated and renewed.
• Submit annual device import data to CDSCO if requested.

What are the penalties for importing without a CDSCO Import License for Class B Medical Devices in India?

Importing medical devices without a CDSCO Import License is a serious legal violation.

S.No.	Violation	Penalty
1.	Import without a license	Product seizure and cancellation of the IEC code
2.	Sale of unapproved devices	Heavy fines and imprisonment (under Section 13 of the Drugs and Cosmetics Act)
3.	Mislabeling or false declaration	License suspension and blacklisting of the importer

How can ELT Corporate help with the CDSCO Import License for Class B Medical Devices in India?

ELT Corporate is one of India’s best regulatory consultancies specializing in CDSCO licensing and medical device compliance.

• Classification and regulatory guidance for Class B devices
• Preparation and submission of Form MD-14 and supporting documents
• Liaison with CDSCO for clarifications
• Label compliance and document review
• Post-approval support and retention management

With ELT Corporate’s expert support, companies can obtain their CDSCO Import License quickly and hassle-free.