Gap assessment
Prepared, reviewed and organised for your medical device import license engagement.
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Medical Device Import License
Import licensing for overseas device manufacturers.
Expert-ledregulatory support.
Starting price₹39999
Service modeOnline & Offline
Typical duration12–24 weeks
CoveragePan India
The service
Professional support,
Professional support,
clearly explained.
AuthorityCentral Drugs Standard Control Organisation
EligibilityLicensed Indian agent and compliant overseas manufacturer
ValidityAs prescribed under the Medical Devices Rules
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
Structured import licence assistance covering authorised Indian agent requirements, overseas manufacturing evidence and device documentation.
What's included
- Authorised agent readiness
- Device master file review
- Plant master file review
- CDSCO coordination
Typical documents required
- Authorised Indian agent documents
- Free sale certificate and overseas approvals
- Plant master file and device master file
- ISO 13485 certificate
- Power of attorney, labels 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.
Filed import application
Prepared, reviewed and organised for your medical device import license engagement.
Query-response pack
Prepared, reviewed and organised for your medical device import license engagement.
Import licence copy
Prepared, reviewed and organised for your medical device import license 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 Medical Device Import License 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 Medical Device Import License.
Who should apply for Medical Device Import License?+
Licensed Indian agent and compliant overseas manufacturer. We confirm exact applicability during the initial review.
How long does the process usually take?+
A typical engagement is planned for 12–24 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.
