India’s medical device industry is growing rapidly, with both domestic manufacturing and international imports driving the sector forward. However, importing medical devices into India requires compliance with strict regulatory frameworks governed by the Central Drugs Standard Control Organization (CDSCO). One of the critical steps in this process is obtaining a Medical Device Import License India. Let’s walk through what this means, why it’s important, and how forms like Form MD-14 and Form MD-15 fit into the process. 

Why Do You Need an Import License in India? 

The CDSCO, operating under India’s Ministry of Health and Family Welfare, regulates the import, manufacture, and distribution of medical devices. As per India’s Medical Device Rules (MDR), 2017, medical devices are classified based on their risk into Class A, B, C, and D. 

For Class A (sterile) and B, Class C, and Class D medical devices, obtaining an Import License is mandatory to ensure that the products meet India’s safety, quality, and performance standards before entering the Indian market. 

The Import License Process in India 

1. Appoint an Indian Authorized Agent 

Foreign manufacturers intending to import medical devices must appoint an Indian entity to act as their Authorized Agent. This entity should hold a valid wholesale or manufacturing license. 

2. Obtain Form MD-42 

Before applying for an import license, the foreign manufacturer must ensure that their Authorized Agent has obtained a Medical Device Registration Certificate (Form MD-42) from CDSCO. This license authorizes the Indian Agent to import, sell, stock, exhibit, or distribute medical devices, including In-Vitro diagnostic devices, to retailers, wholesalers. 

3. Apply for Import License 

The first formal step in the licensing process is the submission of Form MD-14. This application form is submitted to the CDSCO via SUGAM portal, requesting approval to import specific medical devices into India. 

Key information required in Form MD-14 includes: 

• Details of the manufacturer and the Indian Authorized Agent. 

• Device-specific information like classification, intended use, and regulatory status in other countries. 

• Copies of international certifications such as US FDA approval, CE marking, ISO 13485 certificate, etc. 

• Free Sale Certificate from the country of origin. 

• Product master file and device master file. 

 4. CDSCO Review and Grant of Form MD-15 

After reviewing the Form MD-14 application and all supporting documents, the CDSCO will grant the Import License via Form MD-15 if everything is in order. 

The Form MD-15 Import License allows the importer (or their agent) to legally bring the medical devices into India and sell them within the Indian market. 

5. Customs Clearance & Post-Market Surveillance 

Once Form MD-15 is issued, importers can proceed with customs clearance for their medical devices. However, compliance doesn’t end here. Importers must ensure ongoing adherence to India’s post-market surveillance requirements, including reporting adverse events and periodic safety updates to the CDSCO. 

How OMC Medical Can Assist You? 

OMC Medical provides end-to-end support to help manufacturers navigate India’s regulatory landscape. Our services include: 

• Acting as your Indian Authorized Agent and securing Form MD-42 on your behalf. 

• Managing the entire MD-14 and MD-15 submission process. 

• Preparing technical documentation (PMF, DMF, predicate device tables). 

• Assisting in CDSCO communications and ensuring ongoing compliance post-approval. 

With OMC Medical, you’ll gain a trusted regulatory partner to simplify your market entry into India while staying fully compliant. 

Frequently Asked Questions

1. Who can Import a Medical device in the country? 

Any company or entity that holds a valid manufacturing license, a wholesale license, or a registration certificate in Form MD-42 for the sale or distribution of medical devices in accordance with the Medical Devices Rules, 2017. 

2. What is the difference between Form MD-14 and Form MD-15? 

• Form MD-14: This is the application form submitted by the Indian Authorized Agent to CDSCO, requesting approval to import specific medical devices into India. 

• Form MD-15: This is the actual Import License issued by CDSCO after reviewing and approving the MD-14 application. It grants legal permission to import and distribute medical devices in the Indian market. 

3. Is an import license mandatory for all medical devices? 

Yes, an MD-15 Import License is mandatory for importing all Class A (sterile), Class B, Class C, and Class D devices into India. 

4. How long does it take to get the MD-15 license? 

It typically takes 3 to 6 months, depending on the completeness of the submission and device classification. 

5. What is Form MD-42? 

Form MD-42 is a regulatory certificate granted by the State Licensing Authority, authorizing retailers and distributors to legally handle and market medical devices, including in-vitro diagnostic (IVD) devices, within India.