CDSCO Clinical Trials for Medical Devices And IVDs (MD-23 & MD-25)

CDSCO clinical trials for medical devices and IVD (form MD 23 & MD 25) are important in India to make sure that new or high-risk medical devices are safe and effective before being sold. These trials are governed by the CDSCO under the Medical Device Rules, 2017. A producer, importer, or authorized agent who intends to introduce a medical device or in vitro diagnostic (IVD) in India should be aware of how clinical trials operate, when they are required, and how to apply for them using forms MD-23 and MD-25.

What are CDSCO Clinical Trials for Medical Devices and IVDs?

Before being authorized for sale in India, CDSCO clinical trials for medical devices and in vitro diagnostics (IVDs) are testing studies carried out to assess the efficacy, safety, and performance of the product. In accordance with the 2017 Medical Device Rules, the CDSCO oversees these studies.

Why are CDSCO Clinical Trials Mandatory for Medical Devices and IVDs in India?

CDSCO clinical trials for medical devices and IVDs are mandatory in India to assure that that the product is safe, effective, and suitable for Indian patients before it is approved for sale or use. 

Here we have mentioned a few reasons why CDSCO clinical trials are important:

• To Ensure Safety – This trial confirms that the medical device or IVD does not harm patients during use.
• To Check Effectiveness – It proves whether the device gives accurate results or performs its intended function.
• Required for New Devices – If a medical device or diagnostic kit is new in India, CDSCO requires clinical trial data before approval
• For Indian Conditions – It ensures the product works well for Indian patients and local healthcare settings.
• Legal Requirement – Under Medical Device Rules, 2017, CDSCO approval is mandatory before clinical use or market launch.

What is Form MD 23 in CDSCO Clinical Trials for Medical Devices and IVDs?

Form MD 23 is an official application form used to get permission from CDSCO for conducting clinical trials for medical devices and IVDs in India. If a company wants to test a new or unapproved device on participants, they should submit this form CDSCO. This form helps the regulatory body review the trial’s design, safety data, and how the device will be tested before approving it.

• Used to apply for permission to begin a clinical investigation in India.
• Submitted by the sponsor, manufacturer, or their authorized agent.
• Required before human trials start for any new or investigational device or IVD.
• Including device details, clinical protocols, investigator info, and safety data.
• Should be submitted via the SUGAM Portal along with supporting documents.

What is Form MD 25 in CDSCO Trials for Medical Devices and IVDs?

To request permission from the CDSCO to conduct a clinical investigation of a medical device. It is submitted by the sponsor or manufacturer who wants to test the safety and effectiveness of a new device on subjects. 

• Form MD 23 is the approval granted by CDSCO after reviewing the MD 22 application. It officially allows the sponsor to start clinical trials for the medical device in India. 
• Form MD 24 is the application form used to seek approval for clinical performance evaluation of IVD medical devices. This is required when the sponsor wants to test IVD, like diagnostic test kits, reagents, etc., on human samples.
• Form MD 25 is the final approval letter issued by CDSCO after reviewing MD 24, which means the IVD products can now be tested in a performance evaluation study. In simple words, once CDSCO checks that all technical and safety details are in place, Form MD 25 gives permission to start testing the IVD on actual samples.

Who Needs to Apply for CDSCO Clinical Trials for Medical Devices and IVDs ?

Any manufacturer, importer, or authorized agents who want to introduce a new medical device or IVD product into the Indian market should apply for CDSCO clinical trials for medical devices and IVDs if the product:

• Has never been approved in India before.
• Requires safety and performance data in Indian conditions.
• Belongs to high-risk classes (Class C & D)
• Is intended for new indications or a new target population

Which Medical Devices and IVDs Require CDSCO Clinical Trial Approval in India?

CDSCO clinical trial approval for medical devices and IVDs is required when you’re planning to introduce a new, high-risk, or unapproved product in India

• New Medical Devices or IVDs not approved in India before
• Device in Class C or D (Moderate to High risk category)
• Devices with a new intended use, technology, or target population
• IVDs are meant for critical or life-threatening conditions
• When CDSCO requests additional safety or performance data specific to Indian patients

What is the Procedure for CDSCO Clinical Trials for Medical Devices and IVDs?

Here you can check out the easy steps to apply for the CDSCO clinical trial for medical devices and IVDs:

• Determine if a Clinical Trial is Required – First, you have to check the classification of your device or IVD. If it falls under class C or D, or it’s a new, innovative, or high-risk product, CDSCO may mandate clinical trials
• Prepare Clinical Investigation Documents – Collect all the required documents. Design a clinical investigation plan as per ISO 14155 or GCP guidelines.
• Submit Form MD 23 to CDSCO – File Form MD 23 for seeking permission to conduct a clinical investigation in India. This form should be submitted with:

1. Clinical Protocol

• Review by CDSCO – CDSCO evaluates the submission and may request clarification or additional documents. If everything goes well, CDSCO will grant permission to conduct clinical trials via MD 25
• Conduct the Clinical Trial – Conduct the study at an approved trial site with ethical oversight. Ensure periodic monitoring and reporting to CDSCO and ethics committees.

2. Device Technical Details
3. Regulatory Status in Other Countries
4. Preclinical Study Data

• Submit Results Using Form MD 25 – Once the trials are completed, submit Form MD 25 to report trial results to CDSCO. It includes:

1. Financial clinical investigation report
2. Safety data
3. Adverse events
4. Summary of results and conclusions

• Proceed with Product Registration – After approval of the clinical trial results, proceed to apply for a device registration certificate.

Documents Required to Apply for Form MD 23 for Medical Device Clinical Trials

Here is the list of required documents to apply for Form MD 23 for medical device clinical trials:

• Covering Letter
• Duly Filled Form MD 23
• Clinical Investigation Protocol
• Investigators Brochure
• Ethics Committee Approval
• Informed Consent Documents (ICF)
• Details of Investigators & Trial Sites
• Regulatory Status in Other Countries
• Device Master File (DMF)
• Pre-Clinical Safety & Performance Data
• Risk Analysis Report
• Product Labels and Package Inserts
• Agreement with Clinical Investigators
• Insurance Certificate
• Declaration of Conformity
• CDSCO Fee Payment Receipt
• List of Participating Countries

Validity of the Clinical Trials Permission Issued in Form MD 25

The Form MD 25 permission is valid for 2 years from the date of issuance. The clinical trials should begin within this period, and major changes must be informed to the CDSCO.

Can ELT Corporate Help You With CDSCO Clinical Trials for Medical Devices and IVDs?

Yes, ELT Corporate can help you with end-to-end support for CDSCO clinical trials for medical devices and IVD. From preparing document approvals under form MD-23 and MD-25, our experts ensure a smooth and compliant process.

• Expert guidance for Form MD-23 and MD-25 submission
• Support in preparing protocols and regulatory documents
• Assistance in coordinating with ethics committees and CDSCO
• End-to-end trial compliance and documentation support