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How to Sell Medical Devices in India as a Foreign Manufacturer in 2024?

Ready to Enter India's Booming Medical Device Market? Here's What You Need to Know.

India’s healthcare industry is growing rapidly, creating exciting opportunities for foreign manufacturers. But navigating the Medical Device Rules, 2017, can be challenging. To sell medical devices in India legally, you need:

  1. Secure Import Licenses: Obtain an MD 15 Import License from the CDSCO to bring your devices into India.
  2. Partner with a Trusted Authorized Agent: Appoint an MD-42 Licensed Authorized Agent to handle market entry, distribution, and regulatory compliance.

Don’t go it alone! MedDev Experts, India’s leading medical device consultants, can guide you through every step. We offer comprehensive support, experienced Authorized Agents, and proven strategies to help you to sell medical devices in India in the Indian market.

Sell Medical Devices in India: Fast-Track Entry with This Guide.

#1. Classify Your Medical Devices in India for Fast Approvals

All medical devices, including In-Vitro Diagnostics (IVDs), fall into one of four risk-based categories in India:

  • Class A Low-Risk: Simple devices requiring minimal regulatory oversight.
  • Class B Low-Moderate Risk: Devices requiring basic safety and performance data.
  • Class C Moderate-High Risk: Devices needing comprehensive testing and quality management systems.
  • Class D High-Risk: Implantable and life-sustaining devices with stringent approval requirements.

Misclassifying your device can lead to delays and rejection of application. Get expert help from MedDev Experts to ensure accurate classification and a smooth CDSCO approval process to sell medical devices in India.

To sell medical devices in India requires a trustworthy partner: an Indian Authorized Agent. MedDev Experts takes care of everything, from navigating complex CDSCO regulations to managing import logistics and distribution. Here’s what we do for you:

  • CDSCO Liaison: We represent you before the CDSCO, handling applications, approvals, and ongoing compliance.
  • Import & Distribution Expertise: We manage smooth importation, warehousing, and distribution of your devices throughout India.
  • Post-Market Surveillance: We ensure efficient data collection and reporting to meet CDSCO requirements.

Don’t let agent complexities delay your market entry! MedDev Experts has a proven track record of success, helping foreign manufacturers achieve fast approvals and expand their business in India.

Read our article on Finding the Right Authorized Agent for Your Medical Device in India or Contact Us today for a free consultation!

Unlock the Indian healthcare market with the essential MD 15 License. Follow these steps to navigate the CDSCO application process and ensure a smooth import experience:

I. Register on the CDSCO Portal:

  • Create an account on the official CDSCO website.
  • Meticulously prepare all required documents to avoid delays.

II. Navigate the SUGAM Portal:

III. Complete Payment and Submission:

  • Facilitate a seamless application by making the prescribed fee payment through the Bharatkosh portal.
  • Finalize your submission by uploading the digitally signed Form MD-14.

IV. Await License Issuance:

  • CDSCO will provide an application number for tracking and communication.
  • Upon thorough verification, CDSCO grants the MD-15 License, empowering you to import and sell medical devices in India.

Ready to start your MD-15 license application? Get expert guidance and support from MedDev Experts. Contact us today to ensure a hassle-free process and accelerate your market entry!

Struggling with Medical Device Regulations in India?

Get Fast Approvals & Expert Guidance from MedDev Experts (Reduce time by 30%).

Complete List of Documents for MD 15 License:

1. Power of Attorney (POA):

All medical devices, including In-Vitro Diagnostics (IVDs), fall into one of four risk-based categories in India:

  • Authorizes your Indian representative to act on your behalf.
  • Must be authenticated from the Indian Embassy.

2. Manufacturing License:

  • Self-attested copy of your valid manufacturing license
  • Duly apostilled/notarized copies from the device’s country of origin.

4. Inspection/Audit Report:

  • Copy of the latest audit report (within 3 years) from a Notified Body or National Regulatory Authority
  • Notarized copy of ISO 13485 Certificate.

6. Quality Assurance Certificates

  • Notarized copies of CE type examination, CE product quality assurance, or Full Quality Assurance Certificate.

7. CE Design Certificate::

  • Notarized copy of CE Design Certificate 
  • Notarized copy Declaration of Conformity

11. Overseas Manufacturing Site Registration:

  • Notarized copy from the competent authority in the country of origin.

12. Authorized Agent Details:

  • Constitution details of your domestic authorized agent.
  • MD 42 License Copy 

Speed Up Your Medical Device Import to India with MedDev Experts!

Tired of complex import regulations delaying your market entry? We’re India’s leading consultants, trusted by 200+ companies. Our experts handle everything: classification, document prep, CDSCO fees & more. Reduce approval time by 20% and get compliant with confidence.

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