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Unlocking Innovation in India: Permission for Clinical Investigation of Medical Devices (Forms MD-22, MD-23)

For medical device manufacturers, importers, and Clinical Research Organizations (CROs) striving to introduce innovative devices to the Indian market, conducting a clinical investigation is frequently a mandatory and critical step. This rigorous process is essential for evaluating the safety, performance, and clinical effectiveness of a new or significantly modified medical device in human subjects.

In India, this crucial activity is meticulously governed by Forms MD-22 (Application) and MD-23 (Permission) under the Medical Devices Rules, 2017. Regulated by the Central Drugs Standard Control Organization (CDSCO), obtaining these permissions is paramount for bringing safe, effective, and compliant medical technologies to patients across the nation.

Understanding Forms MD-22 & MD-23

These forms are the cornerstone of the regulatory framework for conducting clinical investigations of medical devices in India:

  • Form MD-22: Application for Permission to Conduct Clinical Investigation of a Medical Device.
    • This is the detailed online application submitted to the Central Licensing Authority (CLA) at CDSCO.
    • It requires comprehensive information about the applicant, the investigational device, the detailed clinical investigation plan, and a vast array of supporting documentation. Key inclusions are ethics committee approval and pre-clinical test reports.
  • Form MD-23: Permission to Conduct Clinical Investigation of a Medical Device.
    • This is the official approval document issued by the CLA (typically the Drug Controller General of India) upon successful review of the MD-22 application.
    • Form MD-23 grants the legal permission to proceed with the clinical investigation based on the submitted information, ensuring strict adherence to established regulations and scientific rigor.

These forms are crucial for ensuring that clinical investigations of medical devices are conducted both ethically and scientifically, following all established guidelines.

Who Needs Permissions Under Forms MD-22 & MD-23?

These forms are relevant for any entity intending to conduct clinical investigations of medical devices in India, particularly for new, unapproved, or significantly modified devices. This includes:

  • Medical Device Manufacturers: Both Indian and foreign manufacturers developing innovative devices.
  • Importers: Entities bringing in investigational devices for clinical studies in India.
  • Clinical Research Organizations (CROs): Companies conducting clinical investigations on behalf of manufacturers.

The application process is primarily conducted online through the CDSCO’s SUGAM portal, enhancing efficiency and transparency.

The Rigorous Process:
How to Obtain Permissions Under Forms MD-22 & MD-23

The application process for conducting a clinical investigation is demanding and requires a comprehensive dossier. It typically involves several critical steps:

1. Clinical Trial Protocol Development:

A meticulously detailed clinical investigation plan (protocol) must be developed. This document is the blueprint of your study and includes:

  • Study design (e.g., randomized, observational).
  • Clear objectives and methodology.
  • Precise patient selection criteria and exclusion criteria.
  • Statistically justified sample size.
  • Defined endpoints and data collection methods.
  • Robust statistical analysis plan.

2. Ethical Committee (EC) Approval:

The developed clinical investigation protocol must undergo rigorous review and obtain approval from an independent Ethics Committee (EC). This EC must be registered with CDSCO. This step is paramount to ensure the protection of human subjects’ rights, safety, and welfare throughout the investigation.

3. Investigator Selection & Site Identification:

Identify and select highly qualified investigators and suitable clinical sites. These sites must possess the necessary facilities, equipment, and expertise to competently conduct the proposed investigation according to Good Clinical Practice (GCP) guidelines.

4. Device Information & Justification:

Compile comprehensive information about the investigational medical device. This includes:

  • Detailed technical specifications.
  • Extensive pre-clinical data (e.g., in-vitro tests, animal studies).
  • Thorough risk assessment.
  • A compelling justification for conducting the clinical investigation, highlighting the unmet medical need or benefit.

5. Application Submission in Form MD-22:

The applicant submits the complete application in Form MD-22 online via the CDSCO’s SUGAM portal.

6. Comprehensive Dossier Preparation (Supporting Documents):

The Form MD-22 application must be supported by an extensive set of meticulously prepared documents. This typically includes:

  • Covering Letter: From the applicant, clearly stating the purpose of the submission.
  • Clinical Investigation Plan (Protocol): The full, detailed study protocol, approved by the EC.
  • Investigator’s Brochure: Comprehensive scientific and clinical information about the investigational device.
  • Ethical Committee Approval Letter: Official approval from the registered EC.
  • Informed Consent Form (ICF): The document to obtain voluntary, written consent from study subjects.
  • Investigator’s Undertaking: A formal commitment from the principal investigator(s) to adhere to the protocol and all regulations.
  • Site Details: Comprehensive information about all proposed clinical investigation sites.
  • Device Master File (DMF) / Technical File: Detailed technical documentation of the device’s design, manufacturing, and performance.
  • Pre-clinical and Non-clinical Data: Results from all relevant laboratory and animal studies demonstrating initial safety and performance.
  • Risk-Benefit Analysis: A thorough assessment of the potential risks to subjects versus the anticipated benefits of the device.
  • Manufacturing and Quality Control Information: Detailed information about the device’s production and quality assurance processes.
  • Fee Challan: Proof of payment of the prescribed government application fee.

7. CDSCO Review:

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

  • This review may involve consultation with internal subject matter experts or an external expert committee for complex devices.
  • CDSCO will often raise queries or request further clarifications. Prompt, comprehensive, and accurate responses are crucial for avoiding delays.

8. Grant of Permission (Form MD-23):

If the CDSCO is fully satisfied with the application, ensuring all requirements are met and all queries addressed, the permission to conduct the clinical investigation is formally granted in Form MD-23. The approval process typically takes between one to two months after a complete application is submitted.

Post-Permission Obligations: Continuing Compliance

After successfully receiving Form MD-23, the applicant has ongoing responsibilities to ensure the integrity and compliance of the clinical investigation:

  • Strict Adherence: The investigation must adhere strictly to the approved clinical investigation plan (protocol) and all conditions specified in Form MD-23.
  • Progress Reports: Periodic progress reports must be submitted to CDSCO as per the prescribed timelines.
  • Serious Adverse Event (SAE) Reporting: Any serious adverse events encountered during the investigation must be reported promptly to CDSCO.
  • Final Report Submission: A comprehensive final clinical investigation report must be submitted to CDSCO upon completion of the study.

Key to Success: A well-designed protocol, meticulous and accurate documentation, proactive engagement with the regulatory authority, and ongoing compliance are paramount for a successful and timely approval of your clinical investigation.

Why Partner with an MDR Consultant for Forms MD-22 & MD-23 Permissions?

Navigating the intricacies of clinical investigation permissions for medical devices in India is profoundly challenging and demands specialized expertise. An MDR consultant provides invaluable support, significantly streamlining this critical process:

  • Strategic Regulatory Guidance: We advise on the optimal regulatory strategy for your clinical investigation, considering your device’s classification, existing data, and market objectives.
  • Protocol Review & Optimization: We assist in developing or refining your clinical investigation protocol to ensure it meets not only Indian regulatory requirements but also global scientific and ethical rigor.
  • Expert Dossier Compilation: Our team expertly prepares and compiles the extensive documentation required for Form MD-22, ensuring accuracy, completeness, and strict adherence to CDSCO’s stringent format requirements.
  • 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 Assurance: We ensure that your entire application and proposed investigation strictly adhere to both the Medical Devices Rules, 2017, and the highest ethical guidelines for human subject research, 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 outright 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 critical R&D, innovation, and patient-centric goals.

Are you planning a clinical investigation for your innovative medical device in India?

Contact an MDR consultant today! We offer a free consultation to discuss your specific project, outline the comprehensive requirements for Forms MD-22 and MD-23, and guide you through the entire application process efficiently and compliantly, accelerating your journey to bring safe and effective medical technologies to India.

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