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India’s New IVD Rules: The Big Change Every Manufacturer Must Know!
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In India, every company that makes or imports In-Vitro Diagnostic (IVD) kits like tests for flu, COVID-19, dengue, malaria, etc. must get their products checked and approved before selling them. To do this, the Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) use special government-approved laboratories. These labs test whether the diagnostic kits are accurate, safe, and reliable for Indian conditions. This helps make sure that only trustworthy testing kits reach hospitals and patients. |
In India, manufacturers and importers of In-Vitro Diagnostic (IVD) medical devices must follow a well-defined regulatory pathway before their products can be marketed. One of the most critical steps in this process is the performance evaluation conducted through CDSCO-notified IVD testing laboratories. These labs, designated in collaboration with the Indian Council of Medical Research (ICMR), are responsible for verifying the accuracy, safety, sensitivity, specificity, and reliability of diagnostic kits. This independent validation ensures that diagnostic devices deliver trustworthy results under Indian conditions, reducing the risks of faulty or substandard products reaching patients.
The Medical Devices Rules 2017 regulatory framework establishes strict evaluation criteria for IVD kit approval processes. These newly introduced CDSCO IVD license protocols address this requirement by creating standardized assessment procedures that eliminate regulatory ambiguity while ensuring diagnostic reliability.
The Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO), functioning under the Department of Health Research and Drugs Controller General of India, Ministry of Health and Family Welfare, Government of India, have recently (on August-12-2025) released groundbreaking draft protocols  for In Vitro Diagnostic (IVD) evaluation (Document No: ICMR CDSCO/IVD/GD/PROTOCOLS/11/2025,pdf Link). These draft standards introduce a structured evaluation framework for IVD licensing that enhances regulatory transparency, aligns India’s practices with global norms, and addresses industry demands for clarity.
This effort between CDSCO and ICMR introduces 15 distinct evaluation protocols specifically targeting arboviral disease diagnostics – a strategic choice given India’s tropical climate and endemic disease patterns. These protocols are more than just a compliance requirement; they represent a strategic move towards strengthening public health preparedness. By implementing standardized testing criteria, CDSCO and ICMR aim to streamline approvals, cut down regulatory delays, and create a level playing field for both domestic manufacturers and international companies entering the Indian market.
For stakeholders, the draft protocols also open the door to greater collaboration and accountability. Industry input during the public consultation phase is vital to refine these standards and ensure they balance rigorous safety benchmarks with practical accessibility for manufacturers. Once finalized, the protocols are expected to boost innovation, improve diagnostic reliability, and enhance India’s global standing in the field of regulatory science and medical device quality assurance.
Why These Guidelines Matter?
- Quality Assurance: Confirms that reliable and validated kits are supplied for use.
- Public Health Impact: Reliable diagnosis improves timely treatment and reduces transmission.
- Regulatory Compliance: Helps manufacturers meet CDSCO requirements for market authorization.
- Global Relevance: Aligns India with international best practices (WHO, US FDA, PMDA Japan).
What This Means for Healthcare?
These new guidelines create significant benefits across the healthcare system.
- For doctors: The standardized protocols deliver more reliable test results that support confident treatment decisions, while multi-virus testing capabilities enable faster diagnosis by detecting multiple pathogens simultaneously, ultimately leading to better patient outcomes through accurate detection methods.
- Patients benefit from higher confidence in their test results, experience quicker diagnosis and treatment timelines, and face reduced inconvenience by eliminating the need for multiple separate testing procedures.
- Laboratory professionals gain clear, standardized procedures to follow during kit evaluation processes, enjoy a more streamlined approval pathway for quality diagnostic products, and achieve better integration with their existing laboratory workflows and equipment systems.
Timeline and Implementation
The draft protocols were published in August 2025, and a consultation window was opened to gather inputs from manufacturers, laboratories, clinicians, and other stakeholders. This feedback period remained open until 25th August 2025, giving interested parties an opportunity to share their views and suggest improvements.
Following the deadline, the Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) started examining the submitted feedback. These suggestions will be carefully considered before finalizing the guidelines, ensuring that the protocols are both scientifically robust and practically applicable.
Current Status
Guidelines published August 2025
Feedback Period
Open until 25th August 2025
Implementation
Following final approval after review
To streamline diagnostic validation, ICMR and CDSCO have introduced fifteen separate categories of performance evaluation protocols for IVDs. The protocols are:
A. Respiratory Virus Diagnostics Protocols
- Influenza virus molecular detection and/or differentiation assay (available in single-plex or multiplex formats)
- SARS-CoV-2 molecular detection assay (single plex/multiplex format)
- Respiratory Syncytial Virus (RSV) molecular assay for detection, available in single-plex and multiplex formats
- Diagnostic multiplex method for distinguishing influenza cases from SARS-CoV-2 cases
- Multiplex molecular assay for detection and differentiation of Influenza virus, SARS-CoV-2, and RSV
- Multiplex respiratory virus (expanded panel) Real Time PCR
B. Malaria Diagnostic Protocols
- Malaria rapid diagnostic test (RDT) for P. falciparum and/or P. vivax PER for Malaria ELISA assay
- Malaria ELISA assay
- Malaria real time PCR assay
- Field evaluation protocol for combo Malaria Rapid Diagnostic Test (RDT) kits (detecting P. vivax and P. falciparum)
C. Emerging and High-Risk Pathogen Diagnostics Protocols
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D. Dengue Diagnostic Protocols
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The sections below provide an overview of these fifteen categories, highlighting their scope and importance in strengthening disease detection and public health response
Sections Included:
Respiratory Virus Testing Protocols (covering Influenza, SARS-CoV-2, and RSV)
These protocols focus on molecular assays, both single-plex and multiplex, designed to detect and differentiate key respiratory pathogens such as influenza, SARS-CoV-2, and RSV. These rules ensure all diagnostic tools meet the same high-quality standards across India.
What is Molecular Detection
Molecular detection is a modern diagnostic approach that identifies viruses such as influenza, COVID-19, and respiratory syncytial virus (RSV) by analyzing their genetic material—primarily RNA. Using advanced laboratory techniques like polymerase chain reaction (PCR) and real-time RT-PCR, these tests can directly detect unique viral gene sequences. Unlike traditional methods, which depend on growing viruses in culture or detecting proteins, molecular assays provide faster, more accurate, and highly sensitive results—even when the viral load is very low.
Molecular detection plays a vital role in identifying the exact pathogen responsible. For example:
- Influenza A & B can be confirmed with subtype-specific assays.
- COVID-19 (SARS-CoV-2) can be detected with high accuracy, even in early stages of infection.
- RSV infections, common in infants and the elderly, can be quickly diagnosed to support timely treatment and care.
By pinpointing the virus accurately, healthcare providers can choose the right treatment strategy, reduce unnecessary antibiotic use, and better control outbreaks. Molecular detection assays are available in two key formats:
Single-Plex Testing:
- Each test is limited to diagnosing one virus at a time.
- Useful when the suspected infection is already known or highly likely.
- Example Use: Used to confirm the presence of influenza A or influenza B individually in a specimen.
- Role in IVD: Often employed in influenza molecular diagnostics that focus on a single strain or subtype.
Multiplex Testing:
- Capable of identifying several viruses within one test.
- Critical in patients with similar symptoms where multiple pathogens could be responsible.
- Example Use: Identifying influenza A, influenza B, COVID-19, and RSV
- Commonly applied in respiratory panels such as influenza, SARS-CoV-2, and RSV to enable quick diagnosis.
Five Testing Protocols Explained
- Protocol A: Influenza
- Protocol B: COVID-19
- Protocol C: RSV Testing
- Protocol D: Flu + COVID Combo
- Protocol E: Triple Testing
- Detects seasonal flu types: H1N1, H3N2, and Influenza B
- Can identify specific flu subtypes for better treatment
- Works with single or multiple virus detection systems
- Focuses specifically on SARS-CoV-2 detection
- Suitable for standalone or combination testing formats
- Maintains high accuracy standards despite virus mutations
- Detects Respiratory Syncytial Virus (especially important for children)
- Can distinguish between RSV A and RSV B types
- Critical for pediatric respiratory illness management
- Tests for both influenza and COVID-19 simultaneously
- Saves time and resources in clinical settings
- Useful during respiratory illness seasons
- Detects flu, COVID-19, and RSV all at once
- Most comprehensive respiratory virus panel
- Ideal for emergency departments and clinics
Sample Types and Storage
In the performance evaluation of In-Vitro Diagnostic (IVD) devices, defining appropriate sample types is critical for establishing accuracy and clinical relevance. The choice of sample—such as whole blood, serum, plasma, urine, or swabs—must reflect the intended use of the device. Equally important are the storage conditions, including temperature, duration, and preservation methods, which directly influence sample stability. Adhering to standardized storage requirements ensures that diagnostic test results remain valid, reproducible, and compliant with regulatory expectations.
- Nasal/throat swabs in transport medium
- Frozen storage at -80°C or freeze-dried
- Characterized samples verified by reference tests
- Equal distribution of high, medium, and low viral loads
| Kit Claims | Positive Samples Needed | Negative Samples Needed |
| 99% accuracy | 20 samples | 20 samples |
| 95% accuracy | 80 samples | 80 samples |
| 90% accuracy | 155 samples | 150 samples |
Multiplex Respiratory Virus PCR: Standard Evaluation Protocol Explained
Multiplex real-time PCR assays, which can detect and differentiate several pathogens in a single test, are becoming the gold standard. This protocol provides a structured framework for laboratories, manufacturers, and regulators.
The goal of the analysis is to provide an independent check on the manufacturer’s claims. By using standardized methods, India ensures that every diagnostic kit on the market performs accurately across multiple laboratories. This prevents unreliable kits from entering the system and builds public trust in diagnostics.
Viruses Covered Under the Protocol
The evaluation focuses on detecting a wide range of respiratory viruses, including:
- Influenza A and B
- SARS-CoV-2
- Respiratory Syncytial Virus (RSV)
- Adenovirus
- Human respiroviruses and rubulaviruses, formerly known as parainfluenza virus types 1 to 4
- Human metapneumovirus
- Measles virus
- Rhinovirus and Enterovirus
- Human bocavirus
- Cytomegalovirus
This list was developed under the National One Health Mission, highlighting India’s holistic approach to infectious disease control.
Acceptance Criteria
For a kit to pass evaluation, it must meet the following benchmarks:
- Sensitivity: ≥90% for each virus (ability to detect true positives)
- Specificity: ≥95% (ability to rule out negatives correctly)
- Invalid test rate: ≤5%
- No cross-reactivity with other viruses in the negative panel
If a kit falls short, it cannot be re-evaluated immediately. Manufacturers must make improvements and wait at least three months before re-submitting.
What Manufacturers Must Provide
Manufacturers must include the following documentation with the kitFull instructions for use (IFU)
- Details of pathogens targeted
- Kit components and configuration
- Storage and stability data
- Performance characteristics like limit of detection, sensitivity, and specificity
- Information on biosafety and waste disposal
This ensures transparency and accountability.
How the Evaluation Works?
Sample Selection
- Uses leftover or spiked clinical samples from patients.
- Minimum of 70 positive and 120 negative samples per virus are required.
- Samples should include strong, moderate, and weak positives to test kit accuracy at different levels.
Testing Procedure
- Laboratories use the kit under evaluation along with a reference test (like WHO-prequalified or FDA-approved PCR assays).
- Both tests are run simultaneously to check consistency.
- Internal controls (like housekeeping genes) are mandatory to avoid false results.
Blinding for Accuracy
To avoid bias, laboratory staff do not know the status of the samples they are testing. Only senior investigators manage sample coding and final data analysis.
Reproducibility Checks
- At least three separate kit batches (lots) are tested.
- Results must remain consistent across different lots to ensure reliability in large-scale use.
The CDSCO–ICMR protocol for multiplex respiratory virus PCR evaluation is not just a regulatory formality—it’s a quality safeguard. By setting strict performance standards, India is ensuring that only highly accurate, reproducible, and safe diagnostic kits reach healthcare providers.
Malaria Diagnostic Protocols (Performance Evaluation Protocols for Malaria Diagnostic Kits: RDT, ELISA, and PCR Assays)
Malaria remains a major public health challenge both in India and globally. With the emergence of advanced diagnostic technologies, it has become essential to ensure that In-Vitro Diagnostic (IVD) kits used for malaria detection are reliable, accurate, and consistent.
These protocols define how rapid tests, ELISA kits, PCR assays, and combo diagnostic tools should be validated before they are deployed in healthcare settings.
Evaluation of Malaria Rapid Diagnostic Test (RDT) Kits
RDTs are point-of-care tools widely used for quick malaria detection.
Purpose: To confirm if RDT kits perform as claimed by the manufacturer.
Key Highlights
- Uses archived or spiked clinical blood samples.
- Standard References: RDT kits authorized by global regulators such as WHO, US FDA, PMDA in Japan, and ATAGI.
- Sample requirements: Panels should contain cases of both Plasmodium falciparum (Pf) and Plasmodium vivax (Pv).
- Minimum performance criteria:
- Sensitivity: at least 95% for Pf and 75% or higher for Pv.
- Specificity: at least 95% for Pf and 90% or higher for Pv.
- Reproducibility must be tested across multiple lots and readers.
- Strict blinding is required for staff to avoid bias.
Evaluation of Malaria ELISA Kits
ELISA-based kits detect malaria antigens or antibodies in patient sera.
Purpose: To validate ELISA kits for both parasite detection and sero-surveys.
Key Highlights:
- Panels must contain confirmed positive samples (via PCR) and negative controls.
- Both low and high parasite density samples must be included.
- Required sample numbers vary in relation to the performance claims of sensitivity and specificity.
- Acceptance thresholds:
- Pv ELISA: Sensitivity ≥75%, Specificity ≥95%.
- Pf ELISA: Sensitivity ≥90%, Specificity ≥95%.
- Cross-reactivity must be zero.
- Repeat evaluations only allowed if major kit modifications are made.
Evaluation of Malaria Real-Time PCR (RT-PCR) Kits
PCR assays are gold-standard molecular tests for malaria detection.
Purpose: To verify performance of malaria PCR kits in detecting species-specific parasite DNA.
Key Highlights
- Requires well-characterized malaria-positive and negative panels confirmed by FDA-approved or Snounou protocol PCR.
- Standardized methods and tools must be employed for DNA extraction.
- Reproducibility tested across lots, machines, and readers.
- Minimum acceptance criteria:
- Pf PCR: Sensitivity ≥98%, Specificity ≥98%, LOD 1 parasite/µL.
- Pv PCR: Sensitivity ≥95%, Specificity ≥98%, LOD 1–2 parasites/µL.
- Invalid test rate ≤5%.
Field Evaluation of Combo RDTs (Pf + Pv Detection)
Combo RDTs allows simultaneous detection of P. falciparum and P. vivax.
Purpose: To validate their accuracy under real-world field conditions.
Key Highlights
- Conducted at malaria-endemic sites with suspected cases.
- Panels should represent different parasitemia levels.
- Clinical and epidemiological factors must be considered.
- Acceptance criteria similar to laboratory RDT evaluation, but field reproducibility is crucial
Emerging and High-Risk Pathogen Diagnostics (Protocols for Nipah virus & Chandipura Virus Real-Time PCR Kit)
Protocols for Nipah virus
Nipah Virus Real-Time PCR Kits: Performance Evaluation Guidelines
Nipah virus (NiV) poses a significant public health threat, causing severe respiratory and neurological disease with high fatality. Given its sporadic but deadly outbreaks in India, reliable and rapid diagnostics are critical.
The Challenge of Nipah Diagnosis: Nipah virus diagnosis presents unique challenges:
- Rare but deadly: Outbreaks occur sporadically, making sample collection difficult
- Complex safety requirements: The virus requires BSL-4 laboratory facilities for safe handling
- Multiple sample types: Virus can be detected in throat swabs, urine, cerebrospinal fluid, and blood
- Critical timing: Early detection is essential for patient management and outbreak containment
These protocols aim to validate the accuracy, reproducibility, and safety of PCR kits before their use in clinical and outbreak settings. The protocol is designed to:
- Independently assess the accuracy and reliability of manufacturer statements regarding Nipah PCR kits.
- Standardize evaluation procedures across accredited laboratories.
- Ensure that diagnostic assays meet India’s biosafety and regulatory requirements.
All evaluations use archived or spiked human clinical samples under strict laboratory biosafety (BSL-4) conditions.
Key Components of the Evaluation Framework
- Laboratory Requirements: Biosafety Level 4 (BSL-4) Facilities
- BSL-4 facilities are required for working with Nipah virus samples.
- Ensures maximum safety for laboratory personnel
- Prevents accidental release of the pathogen
- Accreditation Standards
- ISO/IEC 17025 for testing laboratories
- ISO 15189 for medical laboratories
- ISO/IEC 17043 for proficiency testing providers
- CDSCO-approved reference laboratory status
- Performance Standards
- 95% sensitivity: Detects infection accurately in 95/100 patients
- 98% specificity: Accurately rules out infection in 98 of 100 non-infected individuals
- No cross-reactions: Won’t mistake other viruses for Nipah
- < 5% failed tests: Reliable results every time
- Re-testing Rules
- Failed tests cannot be immediately retested
- 3-month waiting period required
- Must show actual improvements
- Protects valuable test samples
- Sample Panel Composition: Reflecting Real-World Scenarios:
Positive Sample Categories (Minimum 80 samples per sample type):
| Negative Sample Panel (80 samples per sample type): The protocol includes comprehensive cross-reactivity testing against diseases with similar symptoms: Respiratory Symptoms Panel:
Neurological Symptoms Panel:
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As India continues to strengthen its health security infrastructure, these protocols serve as a foundation for rapid, accurate response to Nipah virus threats, ultimately protecting public health and supporting global measures implemented to control the transmission and effects of newly emerging infectious diseases.
Protocol: Real-Time PCR Kit for Chandipura Virus:
Chandipura virus (CHPV) is a lesser-known but important cause of viral encephalitis in India. To ensure that diagnostic kits for CHPV are accurate, safe, and reliable, the Central Drugs Standard Control Organization (CDSCO) and the Indian Council of Medical Research (ICMR) have introduced a standardized protocol for evaluating real-time PCR kits. This framework is designed to independently verify manufacturer claims and guarantee that tests used in India meet both national and international quality standards.
Purpose of the Protocol
The protocol’s main goal is to assess how well CHPV PCR kits perform in detecting infections. This is done using carefully prepared panels of clinical or spiked samples. By doing so, authorities can confirm that each kit provides consistent results and can be trusted for public health us.
Key Requirements for Evaluation
To carry out the evaluation effectively, several elements are required:
- Kits Under Review – Complete details about the product, including batch and lot numbers.
- Evaluation Laboratories – Only accredited labs or CDSCO-approved reference labs are allowed to conduct the testing.
- Reference Tests – Validated reference assays or WHO/FDA-recognized kits are used for comparison.
- Evaluation Panels – A well-characterized set of positive and negative samples (serum and CSF) is created, sometimes using spiked samples if clinical ones are scarce.
- Laboratory Supplies – All necessary reagents and consumables are ensured for uninterrupted evaluation.
The Evaluation Process
The protocol follows a structured diagnostic accuracy study.
- Lab Readiness – Laboratories must be ISO-accredited and have trained staff.
- Sample Preparation – Panels include positive and negative samples of different intensities (strong, moderate, and weak positives).
- Testing Procedure – PCR runs are performed on approved machines, often provided by the manufacturer if not available.
- Controls – Internal controls and extraction checks ensure the test is working properly.
- Reference Assay – Results are compared against WHO-approved or ICMR-developed reference methods.
Reporting and Manufacturer’s Role
Manufacturers are required to provide complete details of their kit, including intended use, sample types, storage conditions, stability, internal controls, and test performance characteristics. After evaluation, a Performance Evaluation Report (PER) is generated, summarizing sensitivity, specificity, invalid test rate, and overall performance.
How accuracy is checked
Results are compared with trusted reference assays. Kits must achieve at least 95% sensitivity and 98% specificity with zero cross-reactivity.
End result
A detailed Performance Evaluation Report (PER) is generated, ensuring that only high-quality kits reach healthcare providers.
Dengue In-Vitro Diagnostics: Standard Protocols for Reliable Testing
Dengue continues to be one of the most common mosquito-borne infections in India, leading to seasonal outbreaks and high healthcare burdens. Quick and accurate diagnosis is the backbone of effective dengue management, helping doctors distinguish it from other febrile illnesses and guiding treatment on time.
To ensure that diagnostic kits for dengue are trustworthy, the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) have introduced performance evaluation protocols for various In-Vitro Diagnostic (IVD) tests. These guidelines provide a step-by-step framework to assess the accuracy, reproducibility, and reliability of dengue diagnostic kits before they are approved for wider use.
Types of Dengue Diagnostics Covered:
- Dengue IgG Rapid Diagnostic Tests (RDTs)
These are point-of-care kits designed to quickly detect dengue IgG antibodies.
- Evaluated against WHO-prequalified or FDA-approved reference tests.
- Require both positive and negative serum samples, including cross-reactivity checks with related infections (like chikungunya, malaria, influenza).
- Acceptance criteria: Sensitivity ≥90%, Specificity ≥95%, Invalid test rate ≤5%.
- Dengue IgM/IgG Combo RDTs
These tests detect both IgM (recent infection) and IgG (past or ongoing infection) antibodies together.
- Sample panels must include early and late-phase dengue cases.
- Strict blinding is followed to eliminate bias.
- Reproducibility is checked across at least three kit lots.
- Cut-offs: Sensitivity ≥90% for IgM, ≥85% for IgG; Specificity ≥95%.
- Dengue IgG ELISA Kits
ELISA assays are laboratory-based kits that provide more detailed analysis.
- Require larger sample sizes compared to RDTs.
- Evaluated with both high and low antibody titer samples.
- Must show no cross-reactivity with other flaviviruses or unrelated febrile illnesses.
- Performance acceptance: Sensitivity ≥95%, Specificity ≥98%.
How the Evaluation Is Conducted?
- Sample Selection – To study the performance of Dengue IgG ELISA kits in diagnosing Dengue, employing de-identified archived clinical specimens
- Reference Standards – WHO-prequalified, FDA-approved, or ICMR-validated ELISA/RDT kits serve as the gold standard.
- Blinded Testing – Laboratory staff do not know which samples are positive or negative.
- Reproducibility Checks – At least three kit batches are tested to confirm consistent results.
- Data Analysis – Results are categorized as true positive, true negative, false positive, and false negative.
Manufacturer’s Role
For every kit submitted for evaluation, manufacturers must provide:
- Complete instructions for use (IFU).
- Kit design and principle of testing.
- Intended use, storage, and stability details.
- Sample types validated (serum, plasma).
- Core performance measures, covering sensitivity, specificity, and the smallest detectable amount.
- Safety considerations, including waste disposal methods
Reporting and Outcome
- A Performance Evaluation Report (PER) is prepared after testing, summarizing sensitivity, specificity, reproducibility, invalid test rates, and overall findings.
- The report clarifies that evaluation does not mean product design approval—it only validates analytical performance.
- Kits that do not meet the required standards may be re-tested only after major improvements and a minimum waiting period of three months.
The 2025 CDSCO–ICMR evaluation protocols for dengue diagnostics set strict but necessary standards for rapid tests and ELISA kits. By ensuring only high-performing assays reach the market, India is reinforcing its public health defenses against dengue.
Future Regulatory Landscape
These CDSCO IVD license protocols establish foundational standards that may expand to cover additional disease categories and diagnostic technologies. The framework aligns with WHO prequalification guidelines, potentially facilitating international market access for Indian manufacturers.
Note: The draft guidelines summarized here give a quick overview of the ICMR–CDSCO protocols for evaluating diagnostic kits. For full details and official instructions, please refer to the original draft notice.
Conclusion
The introduction of standardized CDSCO IVD license protocols represents a pivotal advancement in India’s diagnostic regulatory environment. These comprehensive guidelines will enhance diagnostic quality, streamline approval processes, and strengthen public health preparedness.
Success depends on active industry engagement during the consultation period and effective implementation post-finalization. The diagnostic community must collaborate to ensure these protocols achieve their objective of elevating India’s diagnostic standards while maintaining accessibility.
This regulatory evolution positions India as a leader in diagnostic quality assurance, creating opportunities for innovation while ensuring patient safety remains paramount.
How Morulaa Can Help Medical Device Manufacturers?
At Morulaa, our consultants specialize in supporting IVD registration in India and IVDR compliance consulting for manufacturers. We provide guidance to IVD manufacturers on IVDR device classification (Class A–D) following risk and intended use, through a scalable staffing model. Our experts assist with the preparation of critical IVD technical documentation—including intended use, risk classification rationale, and performance evaluation reports. We also perform detailed IVD gap analyses to align existing files with current IVDR requirements. By offering outsourced regulatory expertise, we accelerate compliance and ensure your IVD approval process in India is smooth and audit-ready—eliminating delays that often occur with in-house teams.