##  [Want to Break into the Lucrative Indian Medical Device Market?](/medical-devices/want-to-break-into-the-lucrative-indian-medical-device-market) 

## Want to Break into the Lucrative Indian Medical Device Market?

Accelerate your CDSCO registration process with Freyr Solutions — your trusted partner for navigating India's complex medical device Regulatory landscape.

- **Hassle-free compliance** with local Regulatory bodies
- **Fast-tracked approvals** for import, manufacturing, and market entry
- **Minimized documentation delays** for seamless submissions





#### Speak to an expert









### 200+

Expert Regulatory Professionals



### 1350+

Successful Medical Device Registrations Globally



### 70+

CDSCO Device Approvals in India















## Proven Success Story



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### Seamless CDSCO Compliance for IVD Products: A Proven Success Story

Discover how Freyr Solutions helped a leading US-based manufacturer achieve market entry with

- 28 IVD Products Approved by CDSCO
- Approval secured within just 6 months
- Minimal additional information requests from CDSCO

[Read the Full Success Story](javascript:void(0))









## Freyr India Medical Devices Compliance Services



- Due diligence Report and Regulatory Strategy
- Regulatory Intelligence Report for the Indian market
- Device Classification and grouping strategy
- Device Listing
- Device Registration (Manufacturing License and Import License) 
    - Gap Assessment of device technical documents
    - Compilation of Device Master File (DMF)
    - Manufacturing Site Registration
    - Submission of Application along with the Supporting documents
    - Query Addressal and support till approval
- SUGAM account creation and account management
- Indian Authorized Agent Services 
    - Annual Indian Registration Agent (IAA)
    - Transfer of Indian Authorized Agent (IAA)
- Post-approval device life cycle management
- Labeling Services 
    - Labeling review for CDSCO compliance.
    - Liaison with CDSCO, centra/ and State Licensing Authorities
    - In-country testing services



Explore Freyr’s all-inclusive India Medical Devices services and ensure smooth Regulatory compliance.

[Book a meeting with our Regulatory experts](javascript:void(0))











## Why Partner with Freyr?





- ![]()
    
    ### Comprehensive Support
    
    From pre-submission to post-approval
- ![]()
    
    ### 99% Right-First-Time Accuracy
    
    Save time and resources
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    ### India-Specific Expertise
    
    Deep understanding of Indian regulations
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    ### Seamless IAA Management
    
    Trusted local representation





## Frequently Asked Questions

#### [1. How can I obtain a CDSCO import license for medical devices in India? ](#collapseOne)



Manufacturers must submit technical dossiers, clinical data, and device details via an Indian Authorized Agent. Freyr handles the complete application process.







#### [2. What is the process for CDSCO medical device registration? ](#collapseTwo)



The process includes device classification, technical dossier preparation, and SUGAM portal submission to comply with India’s Medical Device Rules (MDR).







#### [3.How long does CDSCO approval take? ](#collapseThree)



Timelines depend on device classification and submission accuracy. Import license approvals typically take 9 months if documentation is complete.







#### [4. Can US FDA-approved devices gain fast-track CDSCO approval? ](#collapseFour)



Yes, if the device has been marketed in the US for at least 2 years and meets CDSCO safety criteria. Freyr evaluates eligibility and expedites approval.

















[Contact our CDSCO Experts Now! ](javascript:void(0))