Import Permission for IVD Clinical Performance Evaluations (Forms MD-24, MD-25)

For manufacturers, importers, and Clinical Research Organizations (CROs) introducing innovative In Vitro Diagnostic (IVD) Medical Devices in India, conducting a Clinical Performance Evaluation (CPE) is a mandatory regulatory step. This rigorous evaluation assesses an IVD device’s analytical and clinical performance, ensuring its accuracy, reliability, and suitability for its intended diagnostic purpose when used with human samples.

In India, this crucial process is governed by Forms MD-24 (Application) and MD-25 (Permission) under the Medical Devices Rules, 2017, and is meticulously regulated by the Central Drugs Standard Control Organization (CDSCO). Obtaining these permissions is paramount for bringing safe, effective, and compliant new IVD technologies to the Indian market.

What are Forms MD-24 & MD-25?

These forms are the cornerstone of the regulatory framework for conducting Clinical Performance Evaluations of IVD medical devices in India:

·         Form MD-24: Application for Permission to Conduct Clinical Performance Evaluation of a New In Vitro Diagnostic Medical Device.

o   This is the detailed online application submitted to the Central Licensing Authority (CLA) under CDSCO.

o   It outlines the proposed CPE, including the IVD device’s details, the comprehensive evaluation plan, and supporting data demonstrating its in-house performance.

·         Form MD-25: Permission to Conduct Clinical Performance Evaluation of a New In Vitro Diagnostic Medical Device.

o   This is the official permission document issued by the CLA upon successful review and approval of the MD-24 application.

o   Form MD-25 grants legal authorization to conduct the CPE based on the submitted plan, ensuring the evaluation is carried out according to established regulations and scientific principles.

o   The permission in Form MD-25 is typically valid for 2 years, during which the clinical performance evaluation study should commence. Any major changes to the approved plan need to be reported to CDSCO.

Why is a Clinical Performance Evaluation (CPE) Crucial?

The CPE is a systematic and mandatory step for gaining regulatory approval for new IVDs in India, offering several key benefits:

• Systematic Performance Study: It provides a systematic evaluation of your IVD’s performance using actual human samples, directly assessing its effectiveness for its intended use.
• Ensures Safety & Efficacy: The CPE helps gather vital data on the device’s safety and efficacy, which is crucial for demonstrating conformity to the essential principles of safety and performance for medical devices.
• Regulatory Requirement: Conducting a CPE is a non-negotiable step for obtaining market authorization for new IVDs in India.
• Data Collection for Approval: The data collected during the CPE is essential for demonstrating the device’s performance characteristics, such as accuracy, precision, sensitivity, and specificity, under real-world conditions.
• Classification Specificity: Requirements for CPE may vary based on the classification (Class A, B, C, or D) of the IVD, ensuring appropriate rigor for different risk levels.
• Holistic Evaluation: The CPE is part of a larger performance evaluation process, which also includes analytical performance studies.

Who Can Apply for Permissions under Forms MD-24 & MD-25?

Applications for permission to conduct clinical performance evaluations can be submitted by:

• Manufacturers: Companies actively developing and producing new IVD medical devices.
• Importers: Entities responsible for bringing new IVD medical devices into India for evaluation.
• Clinical Research Organizations (CROs): Organizations contracted to manage and conduct performance evaluations on behalf of manufacturers or importers.

Applicants must ensure that the evaluation will be conducted at appropriate clinical laboratories or sites staffed with qualified personnel, all operating under strict ethical committee oversight.

The Detailed Process: How to Obtain Permissions Under Forms MD-24 & MD-25

The application process for conducting a clinical performance evaluation is comprehensive and primarily conducted online through the CDSCO’s Sugam portal. It involves several critical steps:

1. Develop Performance Evaluation Plan (PEP):

Create a meticulously detailed Performance Evaluation Plan (PEP). This foundational document outlines:

• The study design and objectives.
• Methodology for conducting the evaluation.
• Specifics on sample collection and handling.
• Detailed analytical procedures.
• Comprehensive statistical analysis plan.

2. Obtain Ethical Committee (EC) Approval:

The developed PEP must undergo rigorous review and obtain approval from an independent Ethics Committee (EC). This EC must be registered with CDSCO, ensuring the protection of human subjects’ rights and welfare throughout the evaluation.

3. Identify Investigators/Sites:

Select qualified investigators and suitable clinical laboratories or sites. These must possess the necessary facilities, equipment, and expertise to competently conduct the performance evaluation.

4. Compile IVD Device Information:

Gather comprehensive technical specifications and performance data for your IVD device. This includes:

• Detailed technical specifications.
• Pre-existing analytical performance data (e.g., in-house sensitivity, specificity, precision studies).
• A thorough risk assessment for the device.
• A clear justification for conducting the performance evaluation.

5. Submit Application in Form MD-24:

The applicant submits the complete application via the CDSCO’s Sugam portal. This online submission includes the completed Form MD-24 along with all required supporting documentation.

6. CDSCO Review:

The Central Licensing Authority (CLA) at CDSCO conducts a thorough scientific and regulatory review of the submitted application.

• This review may involve expert consultation by subject matter specialists.
• CDSCO may raise queries or request further clarifications. Prompt and comprehensive responses are essential for avoiding delays.
• The government processing time for this approval is typically 1-2 months.

7. Grant of Permission (Form MD-25):

Upon satisfactory review and fulfillment of all requirements, CDSCO grants the official permission to conduct the clinical performance evaluation in Form MD-25.

8. Post-Permission Obligations:

• The study must commence within one year of receiving the permission.
• Any major changes to the approved evaluation plan must be reported to CDSCO.
• After the evaluation is completed, unused devices can be either exported or destroyed, with prior intimation to CDSCO.

Key to Success: A well-designed evaluation protocol, meticulous documentation, and proactive engagement with the regulatory authority are crucial for a successful and timely approval.

Why Engage an MDR Consultant for Forms MD-24 & MD-25 Permissions?

Navigating the complexities of IVD performance evaluation permissions can be challenging and time-consuming. An MDR consultant provides invaluable expertise and support, significantly streamlining this critical process:

• Strategic Guidance: We advise on the optimal regulatory strategy for your IVD performance evaluation, considering your device’s classification, existing data, and overall market objectives.
• Protocol Review & Optimization: We assist in developing or refining your performance evaluation plan to ensure it meets both Indian regulatory requirements and robust scientific rigor, maximizing your chances of approval.
• Expert Dossier Compilation: Our team expertly prepares and compiles the extensive documentation required for Form MD-24, ensuring accuracy, completeness, and adherence to CDSCO’s stringent formats.
• Efficient CDSCO Liaison: We facilitate seamless communication with the regulatory authority, proactively managing queries and addressing any deficiencies raised, thereby significantly expediting the review process.
• Ethical & Regulatory Compliance: We ensure that your entire application and proposed evaluation strictly adhere to both the Medical Devices Rules, 2017, and the highest ethical guidelines, minimizing risks of non-compliance.
• Risk Mitigation: We identify potential regulatory pitfalls early in the process and help you implement strategies to mitigate risks that could lead to costly delays or rejections.
• Time and Resource Efficiency: By handling these complex regulatory aspects, we streamline the application process, saving your organization valuable time and resources. This allows your team to focus on innovation and market development.