,Seamless CDSCO Compliance for IVD Products: A Proven Success Story
Discover how Freyr helped a leading US-based manufacturer achieve Indian market approval through expert Regulatory strategy and device registration with remarkable outcomes –
- 28 IVD products approved by CDSCO
- Approval secured within 6 months
- Minimal additional requests for information from CDSCO
Freyr India Medical Devices Competencies
- 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 managementTransfer of Indian Authorized Agent (IAA)
- 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.
Celebrating Customers Success
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Registration and AR Services
Malaysia and Indonesia
Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.
Robert Menadue
Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company
Why Partner with Freyr?
Frequently Asked Questions
To obtain a CDSCO import license in India, manufacturers must submit the necessary documents, including technical dossiers, clinical data, and device details, through an Indian authorized agent. Freyr provides end-to-end support for import license applications.
The CDSCO medical device registration process involves determining the device classification, preparing a technical dossier, and submitting the application via the SUGAM portal. This ensures compliance with India's Medical Device Rules (MDR).
The timeline for CDSCO approval varies depending on the device classification and the completeness of the application. For instance, CDSCO import license approvals can take approximately 9 months if documentation is accurate and complete.
Yes, US FDA-approved devices may qualify for fast-track approval with CDSCO in India, provided they have been marketed in the US for at least 2 years and meet CDSCO's safety and performance criteria. Freyr specializes in evaluating your device’s eligibility and streamlining the approval process to ensure a smooth and expedited entry into the Indian market.
Your Compliance Journey Starts Here!
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