CDSCO Import License & Medical Device Registration Support in India – Fast, Accurate & End-to-End Support for Form MD-14 / MD-15 Import License, MD-41 / MD-42, Warehouse License & Medical Device Market Access Services
Planning to import, store, sell, stock, exhibit, distribute, or supply medical devices in India? Easy Compliance helps foreign manufacturers, Indian importers, authorized agents, distributors, stockists, warehouse operators, logistics partners, and healthcare product companies manage CDSCO medical device compliance with clarity, accuracy, and confidence.
India is one of the fastest-growing healthcare and medical device markets, but entering and operating in this market requires proper regulatory planning. Medical devices imported into India may require approval from the Central Drugs Standard Control Organization, commonly known as CDSCO.
For many imported medical devices, the application for import license is submitted in Form MD-14, and the import license is granted in Form MD-15 after review and approval.
Along with import license support, companies involved in sale, stocking, exhibition, offer for sale, distribution, warehousing, or supply of medical devices may also require CDSCO MD-41 / MD-42 registration support.
At Easy Compliance, we simplify the complete regulatory journey for you.
With 24 years of experience, our team supports medical device companies with product classification, documentation review, technical file preparation, Device Master File review, Plant Master File support, SUGAM / online portal filing support, CDSCO query handling, MD-41 / MD-42 registration guidance, warehouse compliance support, and post-approval regulatory assistance.
Easy Compliance – Simplify Compliance. Secure Growth.
Our CDSCO Medical Device Services
Easy Compliance provides structured regulatory support for companies planning to import, sell, stock, distribute, or warehouse medical devices in India.
Our services are designed to reduce confusion, avoid documentation gaps, improve submission quality, and help your business move toward compliant market entry and continued operations.
1. CDSCO Import License Support – Form MD-14 / MD-15
If you are importing medical devices into India, you may need a CDSCO import license before placing the product in the Indian market.
Form MD-14 is the application form used for applying for an import license for medical devices.
Form MD-15 is the import licence granted after successful review and approval of the application.
Easy Compliance helps prepare and organise the application package so that your submission is clear, complete, and aligned with regulatory expectations.
Our support includes:
- Application readiness review
- Product information review
- Manufacturer details review
- Indian authorised agent details review
- Device classification mapping
- Document checklist preparation
- Technical file review
- Device Master File support
- Plant Master File support
- SUGAM / online portal filing support
- Query response support
- Follow-up guidance
- Post-approval compliance support
2. CDSCO MD-41 / MD-42 Registration Certificate Support
Along with medical device import licence support, Easy Compliance also assists businesses with CDSCO MD-41 / MD-42 registration for the sale, stocking, exhibition, offer for sale, and distribution of medical devices and in-vitro diagnostic devices in India.
If you are a medical device importer, wholesaler, distributor, stockist, warehouse operator, logistics partner, healthcare product supplier, or company handling medical devices after import, you may need proper registration or licensing support before storing, selling, or distributing regulated medical devices in India.
3. Medical Device Warehouse Licence / Storage & Distribution Support
Medical devices must be stored and distributed under proper conditions to maintain safety, quality, performance, and compliance.
Easy Compliance supports companies that need guidance for medical device warehouse registration, storage compliance, stockist registration, distribution readiness, and documentation preparation.
Our warehouse licence support includes:
- Premises document review
- Warehouse layout review
- Storage condition review
- Temperature and humidity control guidance, where applicable
- Medical device stocking and distribution documentation support
- Technical staff requirement guidance
- Record-keeping system review
- Quality and compliance readiness check
- Application support for MD-41 / MD-42
- Query response and follow-up support
4. MRI, Hospital Equipment & High-Value Medical Device Compliance
Easy Compliance also supports businesses dealing with high-value medical devices and hospital equipment such as MRI machines, diagnostic imaging equipment, monitoring devices, hospital systems, healthcare technology products, and clinical-use equipment.
For products such as MRI equipment and similar hospital-use devices, businesses may need proper import, storage, sale, and distribution compliance before supplying to hospitals, diagnostic centres, healthcare institutions, distributors, or government/private procurement buyers.
We help with:
- Product classification review
- Import licence pathway guidance
- Warehouse and stocking compliance support
- Distributor / importer documentation review
- Sale and distribution registration support
- Technical file and product document review
- CDSCO query handling support
- Post-approval compliance guidance
What is Form MD-14?
Form MD-14 is the application form used for obtaining an import licence for medical devices in India.
It is generally submitted by the Indian authorised agent or importer for the purpose of importing medical devices into the Indian market.
In simple words:
MD-14 = Application for Import Licence
This process may apply to different classes of medical devices depending on the product type, intended use, risk classification, and applicable regulatory requirements.
What is Form MD-15?
Form MD-15 is the import licence granted after review and approval of the Form MD-14 application.
In simple words:
MD-15 = Import Licence Approval
Once granted, it allows the eligible importer or authorised agent to import the approved medical device into India, subject to applicable licence conditions and regulatory requirements.
What is Form MD-41?
Form MD-41 is the application form used for obtaining registration for the sale, stock, exhibit, offer for sale, or distribution of medical devices and in-vitro diagnostic devices.
In simple words:
MD-41 = Application Form for Sale / Stock / Exhibit / Distribution Registration
This is the form submitted by the applicant to seek approval for dealing with medical devices in India after import or for distribution-related activities.
What is Form MD-42?
Form MD-42 is the registration certificate granted after review and approval of the Form MD-41 application.
In simple words:
MD-42 = Registration Certificate / Approval
This certificate allows the eligible business to sell, stock, exhibit, offer for sale, or distribute applicable medical devices and IVDs as per regulatory requirements.
Who Needs CDSCO Import Licence, MD-41 / MD-42 or Warehouse Support?
You may need CDSCO regulatory support if you are:
- A foreign medical device manufacturer selling in India
- An Indian importer bringing medical devices into India
- An authorised Indian agent representing a foreign manufacturer
- A distributor planning to sell imported medical devices
- A medical device wholesaler
- A medical device stockist
- A medical device warehouse operator
- A logistics partner handling regulated medical devices
- A healthcare product supplier
- A diagnostic equipment supplier
- A hospital equipment supplier
- A company supplying MRI or imaging equipment
- A startup launching a medical device
- A private label medical device brand
- A company selling or distributing IVD products
- A company already selling in USA, EU, UK, Canada, or Australia and now entering India
If your product is regulated as a medical device in India, proper classification, import licensing, sale/distribution registration, and storage compliance review should be done before import, sale, stocking, or distribution.
Medical Device Categories We Can Support
Easy Compliance can assist with regulatory pathway understanding for a wide range of medical devices, including:
- Diagnostic equipment
- In-vitro diagnostic devices
- Surgical instruments
- Hospital equipment
- MRI machines
- Diagnostic imaging equipment
- Patient monitoring devices
- Dental devices
- Orthopaedic devices
- Rehabilitation devices
- Sterile medical devices
- Measuring devices
- Home healthcare devices
- Personal health monitoring devices
- Laboratory equipment
- Software as a Medical Device
- Device accessories
- Clinical-use products
- Healthcare technology products
Device Classification Support
Correct classification is the foundation of every medical device compliance process.
For India, medical devices are generally classified into:
- Class A – Low risk
- Class B – Low moderate risk
- Class C – Moderate high risk
- Class D – High risk
We help assess your product based on:
- Intended use
- Risk level
- Duration of contact
- Invasiveness
- Active or non-active nature
- Software or hardware function
- Diagnostic or therapeutic purpose
- Sterile or measuring function
- Patient contact and clinical application
- Applicable device category
Our team helps identify the possible classification and applicable regulatory route before documentation begins.
Our CDSCO Compliance Process
Step 1: Product & Business Activity Review
We review your product details, intended use, manufacturer information, importer details, authorised agent details, business activity, target market, and existing approvals.
Step 2: Device Classification
We help identify the possible device class and applicable regulatory pathway.
Step 3: Licence / Registration Pathway Review
We help you understand whether your requirement is related to:
- Form MD-14 import licence application
- Form MD-15 import licence approval
- Form MD-41 application for sale, stock, exhibit, or distribution
- Form MD-42 registration certificate
- Warehouse / storage and distribution readiness
- Post-approval amendment or renewal support
Step 4: Document Checklist
We prepare a practical checklist based on your device category, business activity, premises, and regulatory route.
Step 5: Gap Assessment
We review available documents and identify missing, weak, inconsistent, or outdated information before submission.
Step 6: Application Preparation
We help prepare the application package and supporting documentation for the applicable CDSCO process.
Step 7: Online Submission Support
We support the submission workflow through the applicable online portal and help keep the application organised.
Step 8: Query Response
If a query, deficiency, or clarification request is raised, we help prepare a structured response with required supporting documents.
Step 9: Approval & Post-Approval Support
After approval, we guide you on licence or certificate conditions, amendments, renewals, product additions, record keeping, and ongoing compliance responsibilities.
Documents Commonly Required for CDSCO Import Licence
Exact requirements may vary based on device type, classification, manufacturer, and regulatory route. However, common documents may include:
- Covering letter
- Form MD-14 application details
- Authorisation letter
- Power of attorney
- Free Sale Certificate
- ISO 13485 certificate
- Device Master File
- Plant Master File
- Product labels
- Instructions for use
- Product catalogue
- Manufacturing site details
- Quality management system details
- Regulatory approvals, if available
- Test reports, if applicable
- Risk management information
- Clinical or performance evaluation documents, where required
- Undertakings or declarations, where applicable
Easy Compliance helps you review the exact documentation requirement before filing.
Documents Commonly Required for MD-41 / MD-42 Registration
Exact requirements may vary based on the state, licensing authority, applicant type, premises, and device category. Common documents may include:
- Form MD-41 application details
- Cover letter
- Applicant business registration documents
- Premises ownership proof or rent agreement
- Site layout / floor plan
- Storage facility details
- Details of medical devices to be sold, stocked, or distributed
- Details of competent technical staff
- Qualification and experience documents of responsible person / technical staff
- Undertaking or declaration for compliance
- Record-keeping and distribution process details
- Applicable government fee proof
- Other documents requested by the licensing authority
How Easy Compliance Helps
1. Eligibility Review
We check whether your product and business activity may require CDSCO import licence, MD-41 / MD-42 registration, warehouse compliance, or distribution-related support.
2. Classification & Pathway Mapping
We help identify the possible device class and the right regulatory route before the application process begins.
3. Document Checklist Preparation
We prepare a clear checklist based on your product type, applicant type, premises, product category, and regulatory need.
4. Technical Documentation Review
A weak technical file is one of the most common reasons for delay. We help review and organise key documentation before submission.
5. Device Master File & Plant Master File Support
For import licence applications, technical and manufacturing documentation must be organised properly. We help review and structure Device Master File and Plant Master File documents so that the application is easier to evaluate and less likely to face avoidable gaps.
6. Premises & Warehouse Readiness Review
We help review whether your warehouse, storage area, or business premises are ready from a compliance perspective.
7. Application Preparation
We support preparation of the applicable application package with required supporting documents.
8. SUGAM / Online Portal Filing Support
CDSCO applications are generally managed through online systems. Easy Compliance supports the filing workflow by helping you organise documents, application details, product information, manufacturer information, authorised agent details, premises information, and submission requirements.
9. Inspection / Verification Preparation
Where premises verification or inspection is applicable, we help you prepare documents, records, storage details, and compliance information in advance.
10. Query Handling
If the licensing authority raises any query or requires clarification, we help prepare a structured response.
11. Licence / Certificate Guidance
After approval, we guide you on Form MD-15 import licence conditions, MD-42 certificate conditions, validity, records, amendments, renewals, and ongoing compliance responsibilities.
Why MD-14 / MD-15 and MD-41 / MD-42 Matter for Your Business
Having the right licence, registration, or certificate helps your business:
- Legally import applicable medical devices
- Legally sell or distribute applicable medical devices
- Build trust with hospitals, buyers, distributors, and procurement teams
- Avoid regulatory issues during inspection
- Maintain proper storage and distribution compliance
- Support safe handling of medical devices
- Strengthen supply chain credibility
- Reduce business risk before scaling operations
- Improve market access confidence
- Avoid unnecessary delays and documentation gaps
Common Challenges Medical Device Companies Face
Many businesses face delays because of:
- Incorrect device classification
- Missing Free Sale Certificate
- Incomplete Device Master File
- Incomplete Plant Master File
- Mismatch between label, IFU, and application details
- Wrong intended use description
- Missing authorisation documents
- Poorly organised technical file
- Lack of Indian authorised agent clarity
- Delayed response to portal queries
- Missing premises or warehouse documents
- Weak storage and distribution records
- Incomplete technical staff documentation
- Confusion between import licence, registration certificate, distribution licence, and manufacturing licence
Easy Compliance helps you identify these issues before submission.
Why Choose Easy Compliance?
24 Years of Experience
Our experience helps you avoid common documentation mistakes and regulatory confusion. We understand that medical device compliance requires practical knowledge, technical clarity, and strong documentation control.
End-to-End Support
We support you from product review and classification to documentation, filing support, query handling, approval guidance, and post-approval compliance.
Strong Documentation Focus
We help prepare a clean, organised, and submission-ready documentation package to reduce avoidable delays.
Practical Regulatory Guidance
We explain the process in simple language so manufacturers, importers, stockists, warehouse operators, and distributors can make confident business decisions.
Support for Indian & International Companies
Whether you are a foreign manufacturer, Indian importer, authorised agent, distributor, stockist, or warehouse operator, we help you understand your role, responsibilities, and documentation requirements.
Faster Market Readiness
Our pre-submission gap review helps identify issues early, so your team can fix them before they become approval delays.
Easy Compliance Advantage
Complete CDSCO Import Licence Support
From classification to Form MD-14 submission support and Form MD-15 approval guidance, we help you manage the full import licence workflow.
MD-41 / MD-42 Registration Support
We help businesses involved in sale, stock, exhibit, offer for sale, and distribution of medical devices prepare for MD-41 / MD-42 registration requirements.
Medical Device Warehouse Licence Guidance
We support warehouse operators, stockists, distributors, and importers with premises documents, storage compliance, record keeping, and distribution readiness.
Class A, B, C & D Device Understanding
We support medical device companies across different risk classes and product categories.
Technical File & Dossier Review
We help organise technical documentation, product information, manufacturing details, premises details, and regulatory documents.
Query & Deficiency Response Support
We help prepare clear responses when authorities ask for clarifications or additional documents.
MRI & Hospital Equipment Compliance
We support importers and distributors of MRI machines, diagnostic imaging equipment, monitoring systems, and other high-value hospital equipment.
Global Market Understanding
We also support companies planning entry into USA, EU, UK, Canada, Australia, and India.
Related Services
You may also be interested in:
Medical Device Classification
Understand your device class and applicable regulatory route.
CDSCO Import Licence Support
Form MD-14 application preparation and Form MD-15 approval guidance.
MD-41 / MD-42 Registration Support
Support for sale, stock, exhibit, offer for sale, and distribution registration.
Medical Device Warehouse Licence Support
Premises document review, warehouse readiness, storage compliance, and distribution documentation support.
Technical Documentation Review
Prepare your technical file, labels, IFU, Device Master File, Plant Master File, and supporting documents before submission.
MRI & Hospital Equipment Compliance
Support for import, storage, sale, and distribution compliance for high-value hospital equipment.
Medical Device Market Access
Plan entry into India, USA, EU, UK, Canada, and Australia.
SaMD Regulatory Support
Support for software-based medical devices and digital health products.
Import Licence Amendments & Renewals
Support for post-approval changes, product additions, and renewal readiness.
Quality Management System Support
Guidance for ISO 13485 and medical device documentation readiness.
Frequently Asked Questions
What is CDSCO import licence for medical devices?
A CDSCO import licence allows eligible importers or authorised agents to import regulated medical devices into India after meeting applicable regulatory requirements.
What is Form MD-14?
Form MD-14 is the application form used for applying for an import licence for medical devices in India.
What is Form MD-15?
Form MD-15 is the import licence granted after successful review and approval of the application.
What is CDSCO MD-41?
MD-41 is the application form used for registration related to sale, stock, exhibit, offer for sale, or distribution of medical devices and IVD devices.
What is CDSCO MD-42?
MD-42 is the registration certificate granted after approval of the MD-41 application.
Who needs MD-41 / MD-42 registration?
Medical device wholesalers, distributors, stockists, warehouse operators, importers, and companies involved in sale or distribution of medical devices may require MD-41 / MD-42 support.
Do MRI machine distributors need CDSCO support?
MRI and other high-value hospital equipment may require proper classification, import, storage, sale, and distribution compliance review before supply in India.
Can Easy Compliance help with medical device warehouse licence?
Yes. Easy Compliance helps with premises document review, warehouse readiness, storage compliance, MD-41 application support, MD-42 certificate guidance, and query handling.
Do all medical devices need CDSCO approval in India?
The requirement depends on product type, classification, intended use, and applicable Indian medical device rules. A classification and pathway review is recommended before import, sale, stock, or distribution.
How can Easy Compliance help?
Easy Compliance helps with classification, documentation review, Form MD-14 application support, Form MD-15 guidance, MD-41 / MD-42 registration support, warehouse licence guidance, technical file preparation, online submission support, query handling, and post-approval compliance guidance.
Planning to Import, Store, Sell or Distribute Medical Devices in India?
Get expert support for CDSCO import licence, Form MD-14 application preparation, Form MD-15 approval guidance, MD-41 / MD-42 registration, warehouse licence support, documentation review, and regulatory query handling.
Please share your product details and our team will guide you on the next step.
Contact Easy Compliance
Call: 9877194003
Email: ecomplaince@gmail.com
Email: info@easycomplaince.com
Website: https://easycomplaince.com/
Easy Compliance
Simplify Compliance. Secure Growth.