Introduction to MD 15 License: License to Import Medical Devices in India
India has emerged as a leading manufacturer of medical devices in the past decade. The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory body that controls the manufacture, distribution and sale of medical devices in India. It is also responsible for granting import licenses for medical devices.
If you are wondering how to import a medical device in India or what is an md 15 license? Then continue reading this blog.
You can also check our service page on the CDSCO import license for more details.
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What Is an MD 15 License?
MD 15 license is the license you will need to import medical devices in India. CDSCO regulates the import of medical devices through the Central Licensing Authority(CLA). CLA will grant the import license. However, the process isn’t so simple.
Form MD 14 and Form MD 15
CDSCO has created a set of forms for you to apply for licenses to use medical devices. There are various categories of forms based on different requirements and risks associated with various medical devices. Form MD 14 and Form MD 15 are required to get an import license.
Form MD 14: It is an application form to get a license to import medical devices of class A, B, C or D.
Form MD 15: It is a license form that CDSCO grants to let people bring medical devices into India based on the classification A, B, C or D.
If you want to know more about MD-3, MD-5, MD-7, and MD-9 in CDSCO, read our blog on Understanding the Significance of Form MD-3, MD-5, MD-7, and MD-9 in CDSCO.
Who Can Apply for MD 15 License?
Following people can/shall apply for a medical device import license:
- An approved agent who has a license to manufacture medical devices for sale or distribution.
- Any wholesaler who wants to import any medical devices for sale and transfer.
- An importer of rapid test kits for coronavirus or any other IVD products
- Any foreign manufacturer who wants to supply test kits for coronavirus in India.
The Ministry of Health and Family Welfare of the Central Government governs the licensing process.
It has an online portal “sugam” through which one can apply for an import license. The application is sent to CLA using the form md 14.
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Process of Getting an MD 15 License
Gather the Necessary Documents
We must ensure that we have all the essential documents before applying for the license. Some of the important documents:
- Legal documentation of importing firm or individual.
- Registration certificate or marketing authorization issued by the regulatory authority.
- ISO certificate or other relevant quality certifications.
- Product-specific technical documents.
Apply on the SUGAM Portal
Register on CDSCO’s online portal- SUGAM by creating a user account as per the guidelines provided.
Log in to the portal and submit the form md 15 along with all the required documents.
CDSCO will review the application and may raise a query or request additional documents. Respond to the queries in time to ensure a smooth review process.
Pay the Fees
Pay the fees applicable for the md 15 license as specified by the CDSCO. You can make the payment through the SUGAM portal.
Inspection and Audit
CDSCO may conduct an inspection or audit at the importing firm’s facility and processes to ensure that it meets the quality standards. Make sure your facility is inspection ready and address any concerns raised during the audit.
Approval of MD 15 License
After viewing the application, and documentation and conducting audits if the CDSCO is satisfied with the results, they will grant the import license to you. The md 15 license will be made available to download from the SUGAM portal. It is generally valid for 5 years from the date of issue and can be renewed.
How Can Operon Strategist Guide You in Getting MD 15 License?
Ready to explore the opportunities in India’s medical device market? Contact us now to guide you through the process of obtaining the MD 15 License and unleash the potential of importing your medical devices to India. Let’s get started!
