The MD 42 License is a mandatory registration required for importing medical devices into India. Under the regulatory framework of the Central Drugs Standard Control Organization (CDSCO), all notified medical devices must obtain proper authorization before being marketed or distributed in the country. The MD 42 license is specifically issued to authorized agents of foreign manufacturers who wish to import medical devices into India.

India regulates medical devices under the Medical Devices Rules, 2017, which function under the broader scope of the Ministry of Health and Family Welfare. The MD 42 license acts as the formal approval granted to an Indian Authorized Agent representing a foreign manufacturer. Without this license, imported medical devices cannot legally enter the Indian market.

Who Requires an MD 42 License?

Any foreign medical device manufacturer intending to sell products in India must appoint an Indian Authorized Agent. This agent then applies for the MD 42 license through the CDSCO online portal. The license covers a wide range of notified medical devices, including diagnostic equipment, surgical instruments, implants, monitoring devices, and more.

Key Eligibility Criteria

To apply for an MD 42 license:

• The foreign manufacturer must comply with quality standards such as ISO 13485.

• The manufacturing site must follow Good Manufacturing Practices (GMP).

• The Indian Authorized Agent must hold a valid wholesale or manufacturing license under applicable drug and cosmetic laws.

Documents Required

The MD 42 application typically requires:

• Power of Attorney from the foreign manufacturer

• Free Sale Certificate from the country of origin

• ISO 13485 certificate

• Device Master File (DMF)

• Plant Master File (PMF)

• Undertaking and declarations

• Details of labeling and packaging

All documents must be properly authenticated and, where applicable, notarized or apostilled.

Application Process

The MD 42 license application is filed online through the CDSCO SUGAM portal. The regulatory authority reviews the submitted documentation and may request clarifications or additional information. In certain cases, inspections of the overseas manufacturing site may be conducted.

Once satisfied, CDSCO grants the MD 42 license, allowing the import and sale of the approved medical devices in India. The approval timeline depends on the device classification (Class A, B, C, or D) and the completeness of documentation.

Validity and Compliance

The MD 42 license remains valid as long as the retention fee is paid every five years. However, license holders must comply with post-approval obligations such as adverse event reporting, record maintenance, and regulatory updates.

Importance of Professional Assistance

Due to the technical documentation and regulatory scrutiny involved, many companies prefer regulatory consultants to manage the application. Proper compliance reduces delays, rejection risks, and financial losses.

About Agile Regulatory

Agile Regulatory provides expert assistance for obtaining MD 42 licenses in India. From document preparation and portal filing to compliance management and post-approval support, Agile Regulatory ensures a smooth and transparent approval process. With in-depth knowledge of CDSCO regulations, the team helps medical device importers secure timely approvals while maintaining full regulatory compliance.