Regulatory Framework to Import Medical Devices in India

India's healthcare landscape has undergone immense growth over the past decade, driven by advances in technological development, increasing healthcare demands and supportive government policies. Among the key drivers of this growth are medical devices – from diagnostic tools to surgical instruments and digital health products. With India being a major market for medical technology, devices, global manufacturers and domestic distributors increasingly seek to import medical devices into the country.

Process to Import Medical Devices in India

However, importing medical devices into India is a highly regulated process to ensure safety, quality, and efficacy. This blog will explore about a comprehensive, detailed guide on the procedures, requirements, applicable fees, and other critical considerations involved in importing medical devices into India.

1. Understanding the Regulatory Framework

Medical devices in India are regulated under the Act of Drugs and Cosmetics,1940 and the Medical Devices Rules, 2017 (MDR 2017), administered by the department of Central Drugs Standard Control Organization which refer as (CDSCO), which functions under the guidelines and regulation of Ministry of Health and Family Welfare.

The CDSCO categorizes medical devices based on their risk levels into four classes:

• Class A: Low risk (e.g., surgical gloves)
• Class B: Low-moderate risk (e.g., hypodermic needles)
• Class C: Moderate-high risk (e.g., bone fixation plates)
• Class D: High risk (e.g., implantable pacemakers)

The regulatory pathway for import depends heavily on the device’s classification.

2. Prerequisites for Import

Before initiating an import, certain foundational requirements must be met:

a) Import-Export Code (IEC)

The importing entity must be a legally registered business in India and possess a valid IEC issued by the authority of Directorate General of Foreign Trade (DGFT). This code is mandatory for customs clearance of imported goods.

b) Approval in Country of Origin

The medical device must be approved by the regulatory authority in its country of origin (e.g., US FDA approval for devices from the USA or CE marking for devices from the EU). This ensures the product is already considered safe and effective in a regulated market.

c) Indian Authorized Agent (IAA)

Foreign manufacturers must appoint an Indian Authorized Agent, who serves as their representative in India. This agent needs to ensures compliance with local regulations, manages documentation, and handles regulatory queries. The IAA must have a valid license and is often the same entity as the importer. 

d) Device Classification Confirmation

The manufacturer/importer should verify and should get confirmation the risk classification (A, B, C, D) with CDSCO's published classification list or seek guidance if unclear.

3. Step-by-Step Procedure to Import Medical Devices

Step 1: Determine the Classification of the Device

• Carefully assess the intended use, mode of operation, and risk factors of the device.
• Classification impacts documentation, review processes and fees.

Step 2: Prepare the Import License Application

For the purpose of importing medical devices in India, an Import License (Form MD-15) is required to get furnished. The application is made using Form MD-14, and it needs to be accompanied by following:

• Cover letter detailing the purpose of import and device details.
• Copy of Import-Export Code (IEC) certificate.
• Free Sale Certificate or Certificate to Foreign Government issued by the regulatory authority in the country of origin, attesting to the device's approval and commercial availability.
• Power of Attorney appointing the Indian Authorized Agent (if applicable), notarized and apostilled.
• Device Master File (DMF) containing technical details such as design, intended use, performance data, material specifications, sterilization, shelf life, etc.
• Plant Master File (PMF) with manufacturing site details, quality systems (e.g., ISO 13485 certification), production process controls, etc.
• Labeling and packaging details, showing compliance with Indian labeling standards.
• Risk classification rationale with justification.
• Clinical evidence or performance evaluation reports if required, especially for Class C and D devices.

Step 3: Submit Application to the Relevant Authority

• For Class A & B devices, the application is submitted to the State Licensing Authority (SLA).
• For Class C & D devices, it is submitted to the Central Licensing Authority (CDSCO headquarters) in New Delhi.

The CDSCO has launched the SUGAM portal, an online system for application submission, tracking, and communication.

Step 4: CDSCO Review and Assessment

• CDSCO scrutinizes the application for completeness and compliance with MDR 2017.
• In certain cases, especially for new, high-risk, or innovative devices, a review by the Subject Expert Committee (SEC) may be required.
• If required, site inspections of the manufacturing facility may be conducted.
• CDSCO may request clarifications, additional data, or testing at a notified laboratory.

Step 5: Grant of Import License (Form MD-15)

Once authority get satisfied, CDSCO grants an Import License (MD-15), which authorizes the import and distribution of the specified device(s) in India.

4. Customs Clearance and Post-Approval Steps

With the Import License in hand:

a. Prepare for customs clearance at the port of entry. Documents required include:

• Import License (Form MD-15)
• Commercial Invoice, Packing List
• Bill of Entry
• IEC
• Certificate of Origin, if required
• Pay applicable customs duties, Integrated GST (IGST), and social welfare surcharge
• Labeling Compliance: Ensure imported devices carry proper labeling including
• Name and address of the importer and manufacturer
• Product name, batch/lot number, manufacturing and expiry dates
• Storage conditions, usage instructions, and regulatory symbols
• Maintain proper storage and distribution records

5. Fee Structure (as of 2025)

Additional costs may arise from:

• Site inspection (if applicable)
• Testing or evaluation at government-authorized laboratories

The Import License is valid indefinitely, subject to retention fees payable every five years, equal to the original license fee.

6. Post-Market Compliance Obligations

Importers and Indian Authorized Agents must:

• Maintain distribution records and implement systems for tracking batches.
• Monitor and report adverse events (AE/Vigilance): Serious adverse events must be reported to CDSCO within 15 days.
• Implement recalls, if necessary, and inform the regulator.
• Comply with quality management system requirements (ISO 13485).

7. Time Duration Required to Import Medical Devices into India

Importing the medical devices into India involves various steps, each has its own time duration. 

A) Preparation and Documentation (2–4 Weeks)

• Gathering all necessary documents, including the Device Master File (DMF), Plant Master File (PMF), Free Sale Certificate, power of attorney, etc., can take 2–4 weeks.
• The time depends on the manufacturer’s readiness and the complexity of the device.

B) Submission and Review by CDSCO (4–12 Weeks)

• For Class A and B devices (reviewed by the State Licensing Authority): Approval may take 4–6 weeks.
• For Class C and D devices (reviewed by CDSCO headquarters): Approval timelines are generally 8–12 weeks, but could be longer if the Subject Expert Committee (SEC) review or site inspections are required.
• If CDSCO requests clarifications, additional data, or testing, this may extend the timeline by 2–4 weeks.

C) Import License Issuance (1–2 Weeks Post-Approval)

• Once the application is approved, the Import License (Form MD-15) is usually issued within 1–2 weeks.

D) Customs Clearance (1–2 Weeks)

• After obtaining the Import License, customs clearance at the port of entry typically takes 1–2 weeks, depending on documentation completeness and customs processing efficiency.

Total Estimated Timeframe

• For Class A & B devices: Approximately 8–12 weeks (2–3 months).
• For Class C & D devices: Approximately 12–20 weeks (3–5 months).

These timelines are indicative; it may vary based on factors such as:

• Complexity of the device and risk classification
• Completeness and accuracy of documentation
• Availability of regulatory staff and clearance slots
• Whether site inspections or testing are required
• External factors like public holidays or unforeseen regulatory delays

8. Customs Duties and Taxation

• Basic Customs Duty (BCD): Generally, between 0% and 7.5%, depending on device type.
• Integrated GST (IGST): Typically, 12% for most medical devices.
• Social Welfare Surcharge (SWS): 10% of the customs duty.

Importers should also explore customs exemptions, preferential trade agreements, or schemes such as Project Imports for large-scale hospital projects.

9. Recent Developments & Considerations

• Regulatory Scope Expanded: The MDR 2017 now covers software-based medical devices, digital health products, and in vitro diagnostics (IVDs).
• SUGAM Portal: CDSCO has digitized many application processes, to maintain the key elements like transparency and efficiency.
• Environmental Regulations: Importers must comply with rules on e-waste management, especially for electronic medical devices.
• Increased Vigilance: CDSCO has strengthened post-market surveillance mechanisms, increasing the responsibility of importers and agents.

Conclusion

Importing medical devices into India is a multi-step, highly regulated process involving detailed documentation, regulatory approvals, customs compliance, and post-market responsibilities. While the procedure might seem complex, a well-prepared importer who is equipped with proper documentation, a good understanding of device classification and regulatory requirements can easily navigate this process successfully. For any assistance, get in touch with CRSPL Business Consultants.

For manufacturers and distributors eyeing India's growing medical device market, compliance, quality assurance, and proactive regulatory engagement are key to seamless operations.