Medical device approvals in India under the Medical Device Rules (MDR) 2017 have become more structured and predictable, but delays still occur frequently. While standard CDSCO timelines range from four to nine months depending on device class and dossier complexity, many applications experience setbacks of one to three months due to avoidable mistakes in documentation, strategy, or classification.
This article explains the top ten issues that commonly slow down CDSCO approvals and provides practical ways to avoid them.
1. Submitting a weak or poorly structured Device Master File (DMF)
One of the biggest reasons for prolonged CDSCO review cycles is an incomplete or non-India-aligned Device Master File. Many manufacturers reuse FDA or CE technical documentation without restructuring it for MDR 2017 expectations. CDSCO reviewers expect clear traceability across safety, performance, design control, and risk documentation.
A DMF that lacks lab test summaries, incomplete design verification data, or unclear risk mapping leads to multiple queries and slows approval.
The way to avoid this is to develop a DMF tailored to India’s format and include a clear mapping table referencing MDR 2017 requirements.
2. Incorrect or unjustified risk classification
This is one of the most common reasons applications are returned for correction. Companies often classify their device based on US FDA risk class, assuming the same applies in India. CDSCO follows a different rule-based framework for risk class determination.
An incorrect class selection can lead to rework, re-submission, or restructuring of the dossier.
To prevent this, applicants must prepare a robust, rule-based classification justification with comparison to similar devices already registered in India.
3. Evidence that does not match Indian intended use
Many companies have strong global clinical or performance evidence, but CDSCO evaluates whether that evidence supports the Indian intended use, patient group, environment of use, and risk profile.
If evidence is not aligned, CDSCO often asks for additional clarification, bridging justifications, or supplementary data.
The solution is to build an evidence-mapping document translating global data into Indian regulatory expectations.
4. Incomplete biocompatibility, electrical safety, or performance testing
Delays often occur due to missing test reports or incomplete test panels. Common issues include:
• partial ISO 10993 biocompatibility
• incomplete sterilization validation
• missing aging or shelf-life data
• incomplete IEC 60601-1 or related collateral standards for electrical devices
When these gaps appear, CDSCO raises detailed technical queries that extend review time.
Planning test protocols specifically for MDR 2017 and ensuring reports follow India-recognized formats can greatly reduce delays.
5. Incorrect predicate device selection
Selecting an inappropriate predicate device is a major reason for timeline extensions. If the chosen predicate has different indications, technology, or risk category, CDSCO is likely to reject the justification.
Applicants should use a structured predicate comparison matrix, demonstrating equivalence across intended use, design, materials, performance, and risk.
6. Labeling and IFU inconsistencies
Labels and Instructions for Use (IFU) are checked carefully by CDSCO. Frequent gaps include:
• importer details missing
• incorrect storage conditions
• missing traceability information
• errors in sterilization symbols
• non-alignment with Schedule IV requirements
Even small labeling errors can produce clarification cycles that add weeks to the approval process.
A detailed labeling audit prior to submission helps avoid such setbacks.
7. Incomplete manufacturing and facility documentation
CDSCO evaluates the manufacturing site thoroughly for Class B, C, and D devices. Many applications are delayed because of:
• ISO 13485 certificates with mismatched scope
• missing sterilization facility documents
• unverified subcontractor details
• outdated QMS procedures
Ensuring all facility documentation clearly covers the device under application is critical to maintaining timely review.
8. Errors in SUGAM form selection and submission
Administrative mistakes on the SUGAM portal often cause delays even before technical review begins. Common issues include selecting the wrong application category, using incorrect forms (MD-5, MD-7, MD-14, etc.), or submitting incomplete fee details.
Using a pre-submission checklist for SUGAM forms eliminates unnecessary administrative delays.
9. Weak or missing post-market surveillance documentation
Post-market surveillance (PMS) is a mandatory requirement in India, but many companies overlook it during submission. CDSCO expects a structured PMS plan including complaint handling, vigilance reporting timelines, recall procedures, and trend analysis.
Incomplete PMS documentation results in additional queries and delays.
Applicants should prepare India-specific PMS procedures aligned with MDR 2017.
10. Slow or partial responses to CDSCO queries
Every round of clarifications adds an average of 15–30 days to the timeline. Delays often occur because manufacturers send incomplete responses or need additional time to coordinate with overseas teams.
To avoid repeated cycles, it is essential to provide a complete, consolidated response within a week of receiving the query.
Conclusion
Most CDSCO approval delays occur not due to regulatory backlogs, but because of gaps in documentation, classification errors, and incomplete data sets. Companies that prepare India-aligned dossiers, ensure test completeness, and maintain proper labeling and PMS documentation consistently achieve faster approvals.
A proactive regulatory strategy can reduce timelines by several months. Expert guidance helps ensure that global evidence, technical files, and clinical data are adapted properly to India’s MDR 2017 framework, enabling smoother and more predictable approvals.
Sources
- Medical Device Rules (MDR) 2017 – Ministry of Health and Family Welfare, Government of India.
- CDSCO Guidance Documents on Medical Device Applications (Forms, Schedules, Risk Classification Rules).
- ISO 13485:2016 – Medical Devices Quality Management Systems.
- ISO 14971:2019 – Application of Risk Management to Medical Devices.
- ISO 10993 series – Biological Evaluation of Medical Devices.
- IEC 60601 series – Medical Electrical Equipment Safety Standards.
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