Import Permission for IVD Clinical Performance Evaluations (Forms MD-24, MD-25)
CDSCO Regulatory Support for IVD Clinical Performance EvaluationBefore a new In Vitro Diagnostic (IVD) medical device can progress through the applicable regulatory pathway in India, clinical performance evidence may be required to demonstrate its performance for the intended diagnostic purpose.
Under the Medical Devices Rules, 2017, clinical performance evaluation of a new IVD medical
device involving specimens derived from the human body can only be conducted in accordance with
permission granted by the Central Licensing Authority (CLA).
The applicable regulatory pathway involves:
Form MD-24 – Application for Grant of Permission to Conduct Clinical Performance Evaluation of a New In Vitro Diagnostic Medical Device
Form MD-25 – Permission to Conduct Clinical Performance Evaluation of a New In Vitro Diagnostic Medical Device
MDR Consultants provides regulatory and documentation support for organisations navigating the applicable CDSCO requirements for IVD clinical performance evaluation in India.
What Are MD-24 and MD-25?
Form MD-24 – Application
Form MD-24 is the prescribed application submitted to the Central Licensing Authority for permission to conduct a clinical performance evaluation of a new in vitro diagnostic medical device.
The application is made by the sponsor and is required to be accompanied by the applicable fee and information specified under Rule 59 of the Medical Devices Rules, 2017.
Government institutions, organisations and hospitals involved in conducting clinical performance evaluation may be subject to the applicable fee provisions specified under the Rules.
Form MD-25 – Permission
Where the Central Licensing Authority is satisfied that the applicable requirements have been complied with, permission to conduct the clinical performance evaluation may be granted in Form MD-25.
The permission relates to the specific new IVD, approved clinical performance evaluation plan and the laboratories or institutions involved in the evaluation.
In Simple Terms
MD-24 = Application for Permission
MD-25 = Permission to Conduct Clinical Performance Evaluation
What is Clinical Performance Evaluation of a New IVD?
Clinical performance evaluation involves generating evidence regarding the performance of a new IVD medical device using appropriate specimens, including specimens derived from the human body.
The evaluation should be designed around the intended purpose and characteristics of the device.
Depending on the nature of the IVD and the approved evaluation plan, relevant performance characteristics may include:
- Sensitivity
- Specificity
- Repeatability
- Reproducibility
- Stability
- Other relevant performance parameters
The exact scope of the evaluation should be supported by the clinical performance evaluation plan and applicable regulatory requirements.
When is MD-24 / MD-25 Permission Required?
Under Rule 59 of the Medical Devices Rules, 2017, no person or sponsor may conduct a clinical performance evaluation of a new IVD medical device on specimens, including blood or tissue derived from the human body, except under and in accordance with permission granted by the Central Licensing Authority.
The applicability of the pathway should therefore be assessed based on:
- Whether the product qualifies as a new IVD medical device
- Intended use of the device
- Nature of the proposed performance evaluation
- Type and source of specimens
- Available performance evidence
- Applicable regulatory requirements
MD-24 & MD-25 Regulatory Process
A typical regulatory pathway may involve the following stages:
Step 1 – Regulatory Assessment of the New IVD
The process begins with an assessment of the proposed IVD and the planned clinical performance evaluation.
Important considerations may include:
• Generic name and description of the IVD
• Intended use
• Device classification
• Diagnostic purpose
• Target analyte or condition
• Type of specimen involved
• Existing analytical performance data
• Available clinical performance information
• Regulatory status in other countries, where applicable
• Scope of the proposed clinical performance evaluation
This initial assessment helps establish an appropriate regulatory and documentation strategy.
Step 2 – Prepare the Clinical Performance Evaluation Plan
A clinical performance evaluation plan forms an important part of the regulatory application.
As specified under the Medical Devices Rules, 2017, the plan should address the purpose and scientific, technical or medical grounds for the evaluation and its scope. Depending on the evaluation, the plan may address:
• Evaluation objectives
• Scientific and medical rationale
• Study methodology
• Scope of the evaluation
• Source and handling of samples
• Performance parameters
• Testing procedures
• Data collection methodology
• Statistical considerations
• Scheduled duration of the evaluation
The clinical performance evaluation should subsequently be conducted in accordance with the approved plan.
Compile Device and Technical Documentation
The MD-24 application should include appropriate information regarding the new IVD medical device.
Relevant documentation specified under the Rules includes information relating to:
• Device description
• Identification details of the device
• Raw material specifications
• Finished product specifications
• Proposed Instructions for Use
• Product labelling
• Regulatory status in other countries, if available
• Other relevant technical information
The documentation should provide a clear and consistent description of the device proposed for clinical performance evaluation.
Compile Available Performance Evidence
The application should include available in-house performance evaluation information.
Under Rule 59, this includes data used to establish relevant characteristics such
as:
• Stability
• Specificity
• Sensitivity
• Repeatability
• Reproducibility
The available evidence should be organised clearly and should remain consistent with the device description and proposed evaluation plan.
Identify Laboratories or Institutions and Investigators
The application requires details of the laboratories or other institutions proposed to participate in the evaluation study.
The selection process should consider whether the participating laboratories or institutions have the appropriate capability to undertake the proposed evaluation.
Relevant application information includes:
• Name and address of participating laboratory or institution
• Details of the Ethics Committee
• Name of the Principal Investigator
• Role of participating sites in the evaluation
Appropriate investigator documentation and undertakings should also be included as required under the applicable regulatory provisions.
Obtain Ethics Committee Approval
The MD-24 application requires approval from an Ethics Committee registered with the Central Licensing Authority, as specified under the applicable regulatory provisions.
The clinical performance evaluation should be initiated only after approval of the clinical performance evaluation plan by the registered Ethics Committee.
Relevant Ethics Committee documentation should form part of the regulatory submission and study records.
Prepare Form MD-24
The sponsor prepares the application in Form MD-24 along with the prescribed information and supporting documents.
The application should include, as applicable:
• Details of the sponsor
• Details of the new IVD medical device
• Intended use
• Device classification
• Source and quantity of samples
• Device description and specifications
• Instructions for Use and labels
• Regulatory status in other countries, where applicable
• In-house performance evaluation data
• Clinical performance evaluation plan
• Case Report Form
• Investigator undertaking
• List of participating laboratories or institutions
• Scheduled duration of evaluation
• Ethics Committee approval
• Required undertaking regarding conformity and protection of health and safety
• Performance evaluation report from an applicable designated laboratory, where required
under the Rules
The documentation should be reviewed carefully for completeness and consistency before submission.
Submit the Application to CDSCO
The application in Form MD-24 is submitted to the Central Licensing Authority through the applicable CDSCO online regulatory system.
The application should be accompanied by:
• Required supporting information
• Applicable documentation
• Prescribed fee, where applicable
• Required declarations and undertakings
Before submission, the applicant should ensure that the information provided across the application, evaluation plan and supporting technical documentation is consistent.
CDSCO Review and Regulatory Queries
The Central Licensing Authority reviews the application and may conduct further enquiry or request additional information where considered necessary.
The regulatory review may consider:
• New IVD device information
• Intended use
• Performance data
• Source and quantity of samples
• Clinical performance evaluation plan
• Participating laboratories or institutions
• Ethics Committee documentation
• Investigator-related information
• Undertakings and declarations
• Other applicable information
Where a query or request for clarification is received, the response should directly address the regulatory requirement and be supported by appropriate documentation.
Grant of Permission in Form MD-25
Where the Central Licensing Authority is satisfied that the applicable requirements have been complied with, permission may be granted in Form MD-25.
Under Rule 59, the Central Licensing Authority may grant permission or reject the application, with reasons recorded in writing, within the period specified under the Rules.
The MD-25 permission is linked to the new IVD medical device, approved clinical performance evaluation plan and identified laboratories or institutions involved in the evaluation.
Conditions After Grant of MD-25 Permission
After receiving permission, the sponsor must comply with the conditions applicable to clinical performance evaluation under Rule 60 of the Medical Devices Rules, 2017.
Key compliance considerations include:
• Ongoing
• Completed
• Terminated
Where an evaluation is terminated, the detailed reasons must be communicated to the Central Licensing Authority within the period prescribed under the Rules.
The Central Licensing Authority may also impose or exempt specific conditions in relation to an individual clinical performance evaluation where considered necessary under the Rules.
Key Documents and Information for MD-24 Application
The exact documentation package should be determined based on the specific IVD and the applicable regulatory requirements.
| Sr. No. | Document / Information |
|---|---|
| 1 | Form MD-24 Application |
| 2 | Sponsor Details |
| 3 | Ethics Committee Approval |
| 4 | Source and Quantity of Samples |
| 5 | IVD Device Description |
| 6 | Raw Material and Finished Product Specifications |
| 7 | Device Identification Information |
| 8 | Proposed Instructions for Use |
| 9 | Product Labels |
| 10 | Regulatory Status in Other Countries, if any |
| 11 | In-House Performance Evaluation Data |
| 12 | Clinical Performance Evaluation Plan |
| 13 | Case Report Form |
| 14 | Investigator Undertaking |
| 15 | List of Participating Laboratories / Institutions |
| 16 | Principal Investigator Details |
| 17 | Scheduled Duration of Evaluation |
| 18 | Required Conformity and Safety Undertaking |
| 19 | Performance Evaluation Report from Applicable Designated Laboratory |
| 20 | Other Information Required by CDSCO |
How MDR Consultants Can Help
MDR Consultants provides regulatory and documentation support for sponsors planning a clinical performance evaluation of a new IVD medical device in India.
- Regulatory Pathway Assessment: We assist in assessing the proposed IVD, intended use and available performance information to understand the applicability of the MD-24/MD-25 regulatory pathway.
- Clinical Performance Evaluation Strategy: We support the development of a structured regulatory approach for planning the clinical performance evaluation.
- Clinical Performance Evaluation Plan Support: Our team can assist with the preparation and organisation of the clinical performance evaluation plan, including the regulatory elements required for submission.
- Technical Documentation Support: We help organise device descriptions, specifications, performance information, labelling and other supporting technical documentation.
- MD-24 Application Support: We assist in compiling and reviewing the information and documentation required for the Form MD-24 application.
- Ethics and Site Documentation Coordination: We provide documentation coordination support relating to participating laboratories, institutions, investigators and applicable Ethics Committee records.
- CDSCO Submission Support: We assist clients with the applicable CDSCO submission process and organisation of the regulatory dossier.
- CDSCO Query Management: Where regulatory queries or requests for clarification are received, we assist in analysing the requirements and preparing structured responses.
- MD-25 Permission Stage Support: We support clients through the regulatory review process and assist in understanding the applicable requirements associated with the MD-25 permission stage.
MDR Consultants – MD-24 & MD-25 Regulatory Support
MDR Consultants provides professional regulatory consulting and documentation support for applicable clinical performance evaluation requirements for new IVD medical devices in India.
