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:
o 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.
o 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.
