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Regulatory Offerings

For nearly a decade we have been setting the industry standards in assisting Medical Device and IVD companies worldwide for end-to-end Regulatory needs and product registration.

COUNTRY-SPECIFIC SERVICES

USA

  • 510(k) Premarket Notification
  • 513(g) Submission
  • US Agent

Canada

  • Medical Device Establishment Listing (MDEL)
  • MDSAP Compliance
  • Medical Device Listing (MDL)

Mexico

  • Device Registration
  • Sanitary Responsible Person (SRP)
  • Post Market Surveillance(PMS)

Brazil

  • Device Notifiication
  • Cadastro and Registro
  • BGMP Compliance

France

  • European Medical Device Classification
  • EU Authorized Representative (EC REP)

European Union

  • EU - ISO 13485:2016 compliance
  • CE Marking
  • EU MDR
  • IVDR Transition

Italy

  • ISO 14971 Risk Management Consultation
  • EU Medical Device Registration

Netherlands

  • In Vitro Diagnostic Regulation (IVDR)
  • Medical Devices Regulation (MDR)

China

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

India

  • Indian Authorized Agent
  • Import License
  • Device Listing
  • Manufacturing License

Indonesia

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

Japan

  • D-MAH / MAH Services
  • FMR Registration
  • Device Registration

Malaysia

  • CAB Assessment
  • MDA approval
  • Local Representation

South Korea

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

Srilanka

  • Device Registration
  • Sample and commercial Import License
  • Local Representation

Taiwan

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

Thailand

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

UAE

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

Vietnam

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

Australia

  • Australian Sponsor Services
  • Conformity Assessment services
  • ARTG Listing

Saudi Arabia

  • Medical Device National Registry (MDNR) Listing
  • Medical Device Marketing Authorization (MDMA)
  • Saudi Arabia Authorized Representation

Proven Expertise

Freyr is uniquely positioned to deploy best vertical/divisional in-house experts to provide  the best Regulatory approach, specifically for combination product portfolio companies.  The customized nature of Freyr services is synchronized keeping in mind our customers’ growth strategy and product portfolio.

Freyr offers you a robust combination of technology and Regulatory expertise  to ensure product continuity, label compliance, and data quality. We are committed  to partnering with companies by providing strategic guidance as they develop,  advance and innovate devices.

  • 600+
    Global Clients
    and Growing
  • 800+
    Global
    Regulatory Experts
  • 120+
    Countries Constitute
    our Regional Medical
    Device Regulatory Services Portfolio
  • 90+
    Medical Device
    Companies Have
    Chosen Us as Their
    Strategic Partner
  • 3
    Forbes Global Top 5
    Medical Device
    Companies Have
    Chosen Us as Their
    Strategic Partner
 

Resource Center

Stay ahead of the curve with the latest updates on Medical Device Regulation, Health Authority Mandates, market trends and developments.

 

  • BlogS

    EU MDR Implementation Deadline Postponed for One Year

    Read More
  • Case studies

    Expedited Product Classification and NIOSH Certification for N95 Respirator

    Read More
  • mandates

    CDSCO, India Has Included 8 New Device Types to The List of Regulated  Medical Devices.

    Read More