Import Authorization for Novel Medical Devices IVDs (Forms MD-26, MD-27)

Bringing a new In Vitro Diagnostic (IVD) Medical Device to the Indian market, whether you plan to import or manufacture it, demands precise regulatory approval. A “new IVD medical device” generally refers to one that hasn’t been previously approved in India or has undergone significant modifications. This critical authorization process, governed by Forms MD-26 (Application) and MD-27 (Permission) under the Medical Devices Rules, 2017, and regulated by the Central Drugs Standard Control Organization (CDSCO), is a mandatory step for market entry.

Securing these permissions ensures your IVD device meets India’s stringent safety, quality, and efficacy standards, paving the way for its successful introduction to the healthcare sector.

Understanding Forms MD-26 & MD-27

These forms define the core application and licensing for new IVD medical devices:

·         Form MD-26: Application for Permission to Import or Manufacture New IVD Medical Devices This detailed application is submitted by the importer or manufacturer to the CDSCO’s Central Licensing Authority (CLA). It’s essential for devices that are genuinely “new” – especially if they lack a predicate device (a similar device already approved in India). The application requires comprehensive data proving the device’s safety, quality, and performance.

·         Form MD-27: Permission to Import or Manufacture New IVD Medical Device This is the official license granted by the CLA (typically the Drug Controller General of India) upon successful review and approval of the MD-26 application. It legally permits the import or manufacture of the new IVD device in India.

The entire application process is primarily conducted online through the CDSCO’s Sugam portal, designed to enhance efficiency and transparency.

Who Can Apply?

Applications for new IVD medical device permissions (MD-26, MD-27) can be submitted by:

• Indian Manufacturers: Companies developing and manufacturing new IVD devices within India.
• Importers: Authorized agents or importers representing foreign manufacturers of new IVD devices. Often, this requires an authorized agent with an existing manufacturing or wholesale license to handle the application.

Applicants must demonstrate comprehensive knowledge of the device, its intended use, and its full compliance with relevant Indian and international standards.

The Detailed Application Process: Navigating MD-26 Submission

Introducing a new IVD device requires a highly detailed application, typically submitted online via the CDSCO’s Sugam portal. It demands extensive documentation and adherence to a structured process:

1. Device Classification & Scope

Accurately classify your new IVD device according to the Medical Devices Rules, 2017. This critical step determines the specific regulatory requirements and the pathway for your submission. Clearly define the device’s intended use and scope to avoid ambiguity.

2. Technical Documentation (Device Master File/Technical File)

Prepare a comprehensive technical dossier that details every aspect of your device. This includes:

• Design and development records.
• Detailed manufacturing processes.
• Rigorous quality control procedures.
• Information on raw materials and components.
• Complete product specifications. This documentation forms the bedrock of your application.

3. Performance Data (Analytical & Clinical)

Provide robust data to demonstrate your device’s capabilities:

• Analytical Performance Data: Show its sensitivity, specificity, accuracy, precision, linearity, limits of detection, and other relevant metrics proving its ability to accurately detect or measure its target analyte.
• Clinical Performance Evaluation Data: (If applicable and required based on risk classification) Present evidence of the device’s effectiveness in a clinical setting. This may involve data from studies conducted in India or other regulated markets. The absence of a “predicate device” often necessitates more extensive clinical data.

4. Risk Management

Develop and submit a comprehensive risk management plan and report in accordance with ISO 14971. This identifies potential risks associated with your device and outlines robust strategies for their mitigation.

5. Quality Management System (QMS) Documentation

Provide clear evidence of a robust Quality Management System (QMS), such as ISO 13485 certification. This demonstrates your commitment to quality throughout both manufacturing and post-market surveillance activities.

6. Application Submission (Form MD-26)

The applicant submits the complete, detailed application in Form MD-26 directly via the CDSCO’s Sugam portal, attaching all the compiled documentation.

7. CDSCO Review

The Central Licensing Authority (CLA) at CDSCO conducts a thorough technical and regulatory review of your submitted dossier. This often involves:

• Detailed scrutiny by subject matter experts.
• Requests for additional information or clarifications, which must be addressed promptly.
• Potentially, an audit of the manufacturing facility (for Indian manufacturers) or a review of the foreign manufacturer’s quality system.

8. Grant of Permission (Form MD-27)

If the CDSCO is satisfied that your new IVD device meets all safety, quality, and performance requirements, the permission to import or manufacture will be officially granted in Form MD-27.

Why Partner with an MDR Consultant for MD-26 & MD-27 Permissions?

The process for obtaining new IVD device approvals is notoriously complex, requiring specialized regulatory and technical expertise. MDR Consultants provide invaluable support, significantly increasing your chances of a successful and timely approval:

• Strategic Regulatory Planning: We’ll advise you on the optimal regulatory pathway for your new IVD device, including pre-submission strategies and precise data requirements, especially considering if your device has a predicate.
• Expert Dossier Compilation: Our team expertly prepares and compiles the extensive technical documentation required for Form MD-26, ensuring accuracy, completeness, and strict adherence to CDSCO regulatory formats.
• Performance Data Optimization: We assist in reviewing and presenting your analytical and clinical performance data in a way that effectively meets CDSCO expectations.
• Efficient CDSCO Liaison: We facilitate smooth communication, manage all queries, and proactively address any deficiencies raised by the regulatory authority, thereby expediting the entire review process.
• Guaranteed Compliance: We ensure every aspect of your application adheres to the Medical Devices Rules, 2017, and relevant Indian/international standards, significantly minimizing the risk of rejection.
• Risk Mitigation: We identify potential regulatory pitfalls early and help you mitigate risks that could lead to costly delays or non-compliance.
• Time and Resource Efficiency: By handling these complex regulatory aspects, we streamline the application process, saving your organization valuable time and resources, allowing you to focus on innovation and market strategy.

Are you ready to introduce your new IVD medical device to the Indian market?

Contact MDR Consultants today for a free consultation! We’ll discuss your specific IVD device and provide expert guidance through the entire process of obtaining permissions under Forms MD-26 and MD-27 efficiently and compliantly.