Medical Device Registration Cost in India

To understand the costs associated with registering medical devices in India, I conducted detailed research by diving into the official resources provided by the Central Drugs Standard Control Organisation (CDSCO), the regulatory body overseeing medical devices in the country. My primary sources were the CDSCO’s official website and its SUGAM online portal, which outline the fee structures and regulatory requirements under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. I also explored discussions on platforms like X to gauge industry perspectives and ensure I captured the most relevant and up-to-date insights. This article presents a clear and concise breakdown of the costs for registering medical devices in India, focusing on manufacturing and import licenses, with fees detailed in Indian Rupees (INR) and US Dollars (USD) as specified by the CDSCO.

Research Approach

My research began with the CDSCO website (CDSCO Medical Device Diagnostics), where I accessed the official fee schedules and regulatory guidelines. The SUGAM portal provided additional clarity on the application process and associated costs. To ensure I wasn’t missing practical insights, I reviewed posts on X from industry professionals and regulatory consultants discussing the registration process, which helped confirm the applicability of the CDSCO’s fee structure. My goal was to compile accurate, straightforward information without relying on generic search engine results, ensuring the data came directly from authoritative sources and reflected real-world experiences.

Regulatory Framework and Device Classification

The CDSCO classifies medical devices into four risk-based categories:

• Class A: Low-risk devices, such as bandages or non-sterile gloves.
• Class B: Low-moderate risk devices, like hypodermic needles or suction equipment.
• Class C: Moderate-high risk devices, including ventilators or bone fixation plates.
• Class D: High-risk devices, such as heart valves or implantable defibrillators.

These classifications determine the regulatory scrutiny and costs involved. Higher-risk devices (Class C and D) incur higher fees due to the need for extensive documentation and oversight. All registrations are processed through the SUGAM portal, which I found to be a streamlined platform for submitting applications and tracking progress.

Manufacturing License Fees

For manufacturers producing medical devices in India, the CDSCO charges fees in INR, structured per manufacturing site and per device. These costs cover the administrative and compliance checks required to ensure devices meet safety and quality standards.

Initial Manufacturing License Fees

• Class A or B Devices:

  • Per manufacturing site: ₹5,000

  • Per device: ₹500

• Class C or D Devices:

  • Per manufacturing site: ₹50,000

  • Per device: ₹1,000

Retention Fees for Manufacturing Licenses

Annual retention fees, required to keep the license active, are identical to the initial fees:

• Class A or B Devices:

  • Per site: ₹5,000

  • Per device: ₹500

• Class C or D Devices:

  • Per site: ₹50,000

  • Per device: ₹1,000

I noted from my research that these fees are relatively affordable compared to other markets, reflecting India’s aim to encourage domestic manufacturing while maintaining regulatory rigor.

Manufacturing Cost Table

Import License Fees

For importers, fees are charged in USD, reflecting the international scope of the process. Costs vary depending on whether the device is a non-In-Vitro Diagnostic (non-IVD) or an In-Vitro Diagnostic (IVD) device, with IVDs having lower per-device fees due to their specific regulatory pathway.

Initial Import License Fees

• Non-IVD Devices:

  • Class A:

    • Per site: $1,000

    • Per device: $50

  • Class B:

    • Per site: $2,000

    • Per device: $1,000

  • Class C or D:

    • Per site: $3,000

    • Per device: $1,500

• IVD Devices:

  • Class A or B:

    • Per site: $1,000

    • Per device: $10

  • Class C or D:

    • Per site: $3,000

    • Per device: $500

Retention Fees for Import Licenses

Retention fees for import licenses, paid annually, match the initial fees:

• Non-IVD Devices:

  • Class A:

    • Per site: $1,000

    • Per device: $50

  • Class B:

    • Per site: $2,000

    • Per device: $1,000

  • Class C or D:

    • Per site: $3,000

    • Per device: $1,500

• IVD Devices:

  • Class A or B:

    • Per site: $1,000

    • Per device: $10

  • Class C or D:

    • Per site: $3,000

    • Per device: $500

Import Cost Table

Comprehensive Cost Table

Below is a table summarizing the registration costs, compiled from my review of CDSCO’s fee schedules. It includes both manufacturing and import fees in their respective currencies:

Additional Fees

My research uncovered additional fees that may apply depending on the device or activity:

• Notified Body Registration: ₹25,000 (for organizations auditing devices).

• Test License for Clinical Investigations: ₹500 per device.

• Overseas Manufacturing Site Inspection: $6,000.

• Permission for Devices Without Predicate: ₹50,000 (for novel devices).

• Permission for New IVD Devices: ₹25,000.

• Testing Laboratory Registration: ₹20,000.

• Export Certificate: ₹1,000 per device.

These fees, while less common, are critical for specific scenarios, such as novel devices or exports, and were consistently listed across CDSCO’s documentation.

Key Considerations

Budgeting for Compliance

Beyond registration fees, I learned that businesses must account for costs like ISO 13485 certification, clinical evaluations (especially for Class C and D devices), and post-market surveillance under the Materiovigilance Programme of India (MvPI). Labeling and packaging compliance also add to the budget, as devices must meet CDSCO’s stringent requirements.

Currency Dynamics

Manufacturing fees in INR simplify budgeting for domestic players, while import fees in USD align with international trade. From X discussions, I noted that importers often factor in exchange rate fluctuations when planning, though CDSCO’s fixed USD fees provide clarity.

Regulatory Updates

The CDSCO’s fee structure is subject to change, and my review of the portal suggests checking regularly for updates. A recent upgrade to the SUGAM system, mentioned in industry discussions, has improved application efficiency but hasn’t altered fees as of April 2025.

Practical Implications

For a manufacturer registering a single Class A device, the initial cost is ₹5,500 (₹5,000 per site + ₹500 per device), with the same amount for annual retention. An importer registering a Class B non-IVD device pays $3,000 ($2,000 per site + $1,000 per device) initially and annually. These costs are competitive globally, but additional compliance expenses can add up, especially for high-risk devices.

Conclusion

My research into medical device registration costs in India, grounded in CDSCO’s official resources and supplemented by industry insights from X, reveals a transparent and risk-based fee structure. Manufacturing licenses cost between ₹5,000 and ₹50,000 per site in INR, while import licenses range from $1,000 to $3,000 per site in USD, with additional per-device fees. Annual retention fees ensure ongoing compliance, and businesses must also budget for quality certifications and surveillance. By regularly consulting the CDSCO portal and staying attuned to industry discussions, stakeholders can navigate this process effectively, tapping into India’s growing $11 billion medical device market.