Submitting a medical device application on the CDSCO SUGAM
portal is only half the job. What truly decides approval timelines is how well
the dossier aligns with CDSCO’s expectations during scrutiny. Many applications
don’t get rejected outright—but they stall, sometimes for months, due to
avoidable queries.
Based on real regulatory reviews and CDSCO scrutiny
patterns, here are the top 10 real reasons applications get stuck on SUGAM, and
how manufacturers can proactively avoid them.
1. Mismatch Between SUGAM Data and Uploaded Documents
One of the most common red flags for CDSCO reviewers is
inconsistency.
Details such as model numbers, device description, intended use, or
manufacturer address often differ between:
- SUGAM
online form
- Device
Master File (DMF)
- Labels
or IFU
Even minor discrepancies trigger clarification queries.
2. Incorrect Device Classification Under MDR, 2017
Misclassification under the Medical Devices Rules, 2017
leads to immediate scrutiny.
Common issues include:
- Incorrect
risk class
- Inadequate
justification against Schedule I
- Overlooking
Indian classification nuances vs EU/FDA
CDSCO expects a clear rule-based classification rationale,
not assumptions.
3. Incomplete or Generic Device Master File (DMF)
A DMF copied from CE or FDA submissions without Indian
adaptation often leads to queries. CDSCO reviewers specifically look for:
- India-specific
intended use
- Applied
standards with versions
- Manufacturing
flow and controls
A weak DMF is one of the biggest causes of prolonged review
cycles.
4. Missing or Outdated Standards & Test Reports
Applications frequently stall when:
- Test
reports don’t reference latest ISO/IEC versions
- Scope
of testing doesn’t match the device variant
- Reports
are missing NABL/ILAC recognition (where applicable)
CDSCO expects standards traceability, not just certificates.
5. Clinical Evidence Not Aligned With Device Claims
For notified and higher-risk devices, CDSCO closely
evaluates:
- Clinical
investigation data
- Literature
summaries
- Predicate
device justification
Generic literature without mapping to device claims often
results in repeated clarification rounds.
6. Labeling & IFU Non-Compliance
Labeling errors are underestimated but heavily scrutinized.
Common issues include:
- Missing
mandatory symbols
- Non-compliance
with Rule 44
- Inconsistent
device name across label, IFU, and SUGAM
Labeling issues alone can hold an application at the final
stage.
7. Manufacturing Site Details Not Properly Evidenced
For import or domestic applications, CDSCO checks:
- ISO
13485 certificate validity
- Scope
alignment with the device
- Manufacturing
site address consistency
Expired certificates or scope mismatch almost always trigger
queries.
8. Poor Justification for Predicate Device
When claiming substantial equivalence, CDSCO expects:
- Clear
technological comparison
- Risk
and performance alignment
- Logical
explanation, not marketing language
Weak predicate logic leads to clinical or safety queries.
9. Incorrect Form Selection or Application Type
Applications get delayed when:
- Wrong
Form (MD-3/MD-5/MD-7 etc.) is selected
- Import
vs manufacturing route is mixed up
- Change
notifications are filed as fresh applications
These errors are procedural but costly in time.
10. Delayed or Incomplete Query Responses
Even strong applications get stuck when:
- Queries
are answered partially
- Supporting
documents are missing
- Responses
are uploaded without explanation notes
CDSCO expects clear, point-by-point responses, not document
dumping.
Why Most CDSCO Delays Are Preventable
In reality, CDSCO queries are rarely arbitrary. Most arise
from documentation gaps, Indian specific misalignment, or lack of regulatory
logic in submissions. Applications that anticipate reviewer expectations move
significantly faster on SUGAM.
For expert support in CDSCO registrations, query
management, and SUGAM submissions, reach out to Titans Medical Consulting.
Sources
- Medical
Devices Rules, 2017 (MoHFW, Government of India)
- CDSCO
Guidance Documents & Notices
- SUGAM
User Manual (CDSCO)
- CDSCO
FAQs on Medical Device Registration