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Regulatory Submission and Registration

Overview

Overview

Medical Devices and in-vitro diagnostics (IVD) registrations and submissions are very specific and different for every Health Authority. As per the regional Regulatory standards, expertise in compilation of all necessary information into Technical File, Device Master File, Design Dossier and Design History File helps in faster reviews and approvals of the devices.

Freyr has a strong Regulatory team to handle Medical Devices and IVD submissions and registrations effectively for all major Health Authorities like the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Health Canada, the Pharmaceuticals and Medical Devices Agency (PMDA), the Therapeutic Goods Administration (TGA) etc. Either premarket notification or premarket application or for classification of devices, Freyr has the global expertise to ensure compliant market-entry for devices. 
 

Freyr Expertise and Advantages
Expertise

Freyr Expertise

  • Medical Device submissions for
    • Premarket Notification [510(k)], Premarket Application [PMA], De Novo, Humanitarian Device Exemption (HDE) in USFDA
    • CE Submission - Technical File Submission and Conformity Assessment
    • Device classification, ARTG listing and Conformity assessment in Australia
    • CDSCO, India Medical Device Registration including Device Master File (DMF) submission
    • Different types of application in PMDA, Japan: Notification (Class I Devices), Certification (Class II Devices) and Approval (Class III Devices)
    • Foreign Manufacturer Registration (FMR) in PMDA, Japan
    • Health Canada Medical Device Establishment License (MDEL) and Health Canada Medical Device License (MDL)
    • Product Classification System (PCS), Medical Device Listing (MDNR), Medical Device Marketing Authorization (MDMA) in Saudi Food and Drug Authority (SFDA)
    • Clinical Investigation Submissions (EU, US, Canada, Australia)
    • Applications in different MENA and African countries
  • Regulatory consultation and pre-submission support for
    • Country-specific device class identification
    • Class-specific device submission pathways identification
    • Compilation and Gap Analysis of common technical documents required for submission
    • Support in finalization of QMS documents
    • Support in clinical trial documentation
    • Local Agent services
    • Support in searching of local distributor
    • Addressing Health Authority queries
    • Support in registration of establishment on behalf of client
    • Support in local language translation and notarization
    • Support in country-specific labeling and artwork drafting
Advantages

Freyr Advantages

  • Experienced Regulatory professionals to provide end-to-end registration support
  • Freyr’s global Regulatory affiliates in 120+ countries
  • Accurate and scientific justification to HA queries
  • ISO 27001 certified company (Information security management system)