Classification memo
Prepared, reviewed and organised for your cdsco medical device registration engagement.
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CDSCO Medical Device Registration
Registration support for regulated medical devices in India.
Expert-ledregulatory support.
Starting price₹24999
Service modeOnline & Offline
Typical duration8–16 weeks
CoveragePan India
The service
Professional support,
Professional support,
clearly explained.
AuthorityCDSCO / Central or State Licensing Authority
EligibilityCorrect classification, quality system and technical evidence
ValidityDepends on device class and applicable licence pathway
The License Sathi Promise
We believe in applicability first. Our compliance specialists run pre-checks on your documents and premises layout drawings before filing with the authority. This reduces rejection rates by over 80%.
Need custom assistance?
- hello@licensesathi.in
- Average response: 1 business day
- All states and Union Territories covered
Classification-led CDSCO registration support for Indian manufacturers and importers of medical devices under applicable Medical Devices Rules.
What's included
- Device classification assessment
- Technical dossier review
- SUGAM portal application
- Regulatory query response
Typical documents required
- Device classification and intended-use statement
- Device master file
- Quality management certificates
- Risk management and performance evidence
- Labels, instructions for use and regulatory forms
Requirements can vary by state, device class, business structure and authority queries. We confirm the final checklist after an applicability review.
What you receiveA clearer path from
A clearer path from
requirements to readiness.
The engagement is structured around usable outputs—not vague advice—so your team can see what has been reviewed, prepared and submitted.
Application dossier
Prepared, reviewed and organised for your cdsco medical device registration engagement.
Submission receipt
Prepared, reviewed and organised for your cdsco medical device registration engagement.
Registration approval
Prepared, reviewed and organised for your cdsco medical device registration engagement.
Your service journeyEvery stage has a
Every stage has a
defined next step.
You receive a practical view of progress from the first applicability check through filing and authority follow-up.
Applicability review
We confirm how CDSCO Medical Device Registration applies to your organisation, location and intended activities.
Gap and document review
Your available records are checked against the authority checklist and practical readiness requirements.
Preparation and filing
Forms, declarations and supporting evidence are organised into a submission-ready application.
Tracking and resolution
We track progress, coordinate clarifications and help close authority observations through the decision stage.
“A strong application is not just a collection of documents. It is a consistent evidence trail showing that the people, premises, processes and controls meet the applicable requirement.”
License Sathi Compliance DeskPractical, document-led regulatory support
Common questionsBefore you
Before you
get started.
Clear answers to the questions clients usually ask before beginning CDSCO Medical Device Registration.
Who should apply for CDSCO Medical Device Registration?+
Correct classification, quality system and technical evidence. We confirm exact applicability during the initial review.
How long does the process usually take?+
A typical engagement is planned for 8–16 weeks. Actual authority timelines can vary based on location, application completeness, inspection scheduling and queries.
Can License Sathi guarantee approval?+
No consultant can ethically guarantee a government or certification decision. We improve readiness, accuracy and response quality while the competent authority retains final discretion.
Will I receive a final document checklist?+
Yes. After the applicability review, we provide a requirement-specific checklist and identify missing, expiring or inconsistent records before filing.
