GI surgery devices, ligating clips, laparoscopic instruments, orthopaedic implants, arthroscopic devices, wound closure and sutures, triclosan-coated products.
Clinical Investigation of Medical Devices & Clinical Performance Evaluation of IVDs in India
Studies Completed26
Companies Supported19
Medical Device Studies20
IVD Studies6
Why India is a Credible Source of Clinical Evidence
for Global Manufactures
Large, Diverse Patient Population
1.4 billion population with high disease prevalence across cardiovascular, oncology, metabolic, infectious disease, and surgical categories-enabling faster enrolment and diverse demographic evidence.
Recognised Institutional Oversight
CTRI registration and Institutional Ethics Committee approval at each site provide institutional oversight aligned with international regulatory expectations.
Cost-efficient Evidence Generation
By conducting Medical Device and IVD clinical studies in India, CliniExperts enables sponsors to obtain high-quality, internationally recognized clinical evidence at a considerably lower cost per patient than comparable studies in the US, EU, or UK.
Streamlined Regulatory Pathway
Implementation of the MDR 2017, along with SUGAM and NSWS, has streamlined CDSCO approvals, enabling transparent application tracking and predictable approvals within 4–5 months after successful SEC/IVD committee deliberations.
GCP-trained Investigator Network
CliniExperts' site network comprises GCP-trained investigators experienced in international and India-specific clinical studies-across hospitals, diagnostic labs, and specialty centres.
Globally Harmonized Regulatory Compliance
Clinical investigations conducted in compliance with ISO 14155 (and ISO 20916 for IVDs), generate globally aligned clinical evidence that supports regulatory submissions across IMDRF member jurisdictions.
Talk to Our Clinical Team
About designing an India medical device and IVD study that meets your home-market regulatory requirements.
Medical Device & IVD Product Category Experience
Medical Device categories
we have supported
In vitro diagnostic devices for biomarker-based detection and assessment of acute kidney injury, including urinary biomarker assays for early clinical risk identification and diagnostic performance evaluation.
In Vitro Diagnostic (IVD)
categories we have supported
Aligning Global Innovation with Compliant Evidence
Generation in India
Supporting global innovators under these frameworks
US FDAEMAMHRAHealth CanadaPMDACDSCO
We provide end-to-end clinical and regulatory solutions for medical devices and IVDs in India, from study design to clinical evidence generation. Our programmes align with ISO 14155 and ISO 20916, supporting regulatory requirements across India and global markets.
Trusted by MedTech and Diagnostics Companies Globally
CliniExperts has supported programmes across sponsors including Healthium Medtech, Masimo Corporation, Philips, Baxter, Galderma, Omron, Ascensia Diabetes Care, Qawach Bio, Genie Laboratories, Onecrea Medical, Curo Biosciences, and OTONEXUS Medical Technologies.
Frequently Asked Questions
What types of studies are included in IVD (in vitro diagnostic) clinical performance investigations?
What types of studies are included in IVD (in vitro diagnostic) clinical performance investigations?
There are generally five main types of studies:
Analytical Performance Study: Assesses the device's technical ability to correctly measure/detect the target analyte (e.g., accuracy, precision, sensitivity, specificity, limit of detection) — done in a lab setting, not on patient outcomes.
Clinical Performance Study: Evaluates how well the device performs its intended clinical purpose in the target population (e.g., diagnostic sensitivity/specificity), using real patient samples, typically non-interventional.
Interventional Clinical Performance Study: A study where test results directly influence patient management/treatment decisions, requiring closer regulatory oversight due to potential patient impact.
PMPF (Post-Market Performance Follow-up): Ongoing post-market studies confirming clinical performance and safety throughout the device's lifetime, required under IVDR (the IVD equivalent of PMCF).
PMS (Post-Market Surveillance): Broader system for monitoring marketed IVDs (complaints, vigilance, trends); PMPF is one part of it.
How important is a good clinical trial design, powered with sample size calculation?
How important is a good clinical trial design, powered with sample size calculation?
Medical Side: A good trial design means asking the right question the right way — clear patient criteria, fair comparison groups, and reduced bias. This protects patients and ensures the results actually mean something for real-world use.
Statistical Side: Correct sample size ensures the study is big enough to find a real effect (not missing it) but not bigger than needed (avoiding unnecessary risk to extra patients). It also makes the study more likely to be accepted by regulators and avoids costly repeat trials.
What is a clinical investigation for Medical devices and IVDs in India?
What is a clinical investigation for Medical devices and IVDs in India?
A clinical investigation is a structured study in human subjects designed to assess the safety and/or performance of a Medical device or an in vitro diagnostic (IVD) product before it can be authorized for use in the Indian market. These investigations are essential when the device is new, lacks predicate (similar approved product) data, or belongs to risk-based categories that require evidence of demonstration. In practice, this means running a full clinical evaluation for Medical device and IVD program, since the underlying process for clinical investigation and evaluation of Medical devices and IVD is very similar regardless of the product category.
What is Data Management Support in clinical trials?
What is Data Management Support in clinical trials?
Data Management Support covers the systems and processes used to collect, clean, validate, and store clinical trial data so that it is accurate, complete, and audit-ready. This typically includes designing case report forms (CRFs), setting up an electronic data capture (EDC) system, running data validation and query resolution, maintaining data security and traceability, and preparing the final locked database for statistical analysis and regulatory submission. Strong data management is a core part of any credible IVD clinical evaluation or device trial, since regulators and ethics committees rely on this data to judge whether a product's safety and performance claims are properly supported.
What regulatory approval is needed to conduct a Medical device or IVD clinical investigation in India?
What regulatory approval is needed to conduct a Medical device or IVD clinical investigation in India?
Sponsors or manufacturers must obtain permission from India's Central Drugs Standard Control Organization (CDSCO) via the appropriate application form (e.g., Form MD-23) before initiating a clinical investigation for Medical devices. The process involves review by regulatory authorities and ethics committees to ensure compliance with applicable regulations.
When is a Medical device or IVD clinical trial required in India?
When is a Medical device or IVD clinical trial required in India?
A clinical investigation for Medical device approval is typically required for high-risk Medical devices and IVDs (Class B, C, and D) that don't already have an approved predicate or prior approval in countries like the USA, EU, UK, Australia, or Japan. However, even low-risk (Class A/B) products may need to be evaluated under certain criteria, and in many cases a documented clinical evaluation for Medical device and IVD can be used to justify why a full trial is or isn't needed.
Is it necessary to register an MD/IVD clinical investigation with a public registry?
Is it necessary to register an MD/IVD clinical investigation with a public registry?
Yes, once regulatory and Ethics Committee approvals are in place, the trial must be registered with the Clinical Trials Registry-India (CTRI) before enrolling the first participant. This step forms part of the broader clinical investigation and evaluation of Medical devices process that regulators expect sponsors to document from start to finish, just like for other regulated products.
How does CliniExperts Research support regulatory and ethics requirements?
How does CliniExperts Research support regulatory and ethics requirements?
CliniExperts Research assists sponsors in preparing necessary documentation, coordinating with ethics committees and regulatory authorities, and ensuring project activities comply with applicable regulations. Their team supports every stage of the clinical evaluation for Medical device and clinical evaluation for IVD pathways, including pre-trial regulatory interactions to clarify requirements and smooth the approvals process.
Why do MD/IVD clinical trials need dedicated project management?
Why do MD/IVD clinical trials need dedicated project management?
Clinical trials involve complex processes, multiple stakeholders, strict regulations, and detailed documentation. Effective project management ensures that these moving parts are aligned, risks are mitigated, timelines are maintained, budgets are controlled, and regulatory standards like Good Clinical Practice (GCP) are upheld throughout the trial lifecycle — an approach that is especially critical when a study is run as part of a combined MD/IVD clinical evaluation program covering both device and diagnostic components.
Can CliniExperts Research tailor site management support for different types of clinical studies?
Can CliniExperts Research tailor site management support for different types of clinical studies?
Yes. CliniExperts Research offers customized site management services aligned with your study's requirements — covering drugs, Medical devices, biologics, nutraceuticals, and consumer claim studies — while adhering to global quality standards and local regulations. This includes tailored support for clinical evaluation for in vitro diagnostic kits, where sample logistics and site training needs differ from a typical device trial.
Expert Articles
Clinical Trials |
Medical Devices
Choosing the Right CRO for Medical Device Clinical Trials
Short Summary A Medical Device CRO provides specialised support for planning, managing, and conducting clinical investigations for Medical Devices. Choosing a CRO for medical device clinical trials helps improve study quality, manage challenges effectively, and support successful trial completion. Strong regulatory expertise, Good Clinical Practice compliance, and quality management systems help ensure that clinical investigations
Biologicals |
Clinical Trials |
Diagnostic Kits |
Drug |
Medical Devices
Understanding Informed Consent in Clinical Research
Informed consent in clinical research is a cornerstone of ethical regulatory compliance. It ensures that participants voluntarily decide whether to take part in a study after receiving adequate information about its purpose, procedures, risks, benefits, and alternatives. It is an ongoing process that promotes transparency, protects participants’ rights, and supports autonomous decision-making. Introduction Informed consent
Medical Devices
WPC Import License for Wireless Devices in India
WPC import license India is a mandatory regulatory approval required for importing wireless and radio-frequency-enabled devices into the Indian market under the WPC framework. Understanding WPC Compliance in India The Wireless Planning and Coordination Wing (WPC) operates under the Department of Telecommunications in India. It regulates wireless communication equipment and radio frequency usage. Manufacturers and
Medical Devices
How to Conduct Clinical Performance Evaluation for IVDs in India
Clinical performance evaluation for IVDs ensures that in vitro diagnostic devices introduced into the Indian market provide accurate, reliable, and clinically meaningful results. Manufacturers can demonstrate the diagnostic value of their products while supporting patient safety and effective disease detection by following the regulatory requirements established under Medical Device Rules, 2017, and generating robust clinical
