Overview

There are instances where a device is classified as a Class I in one country and the same is recognized as a Class II or Class III by the Health Authority (HA) of another country. In such scenarios, organizations cannot afford any misinterpretation while going for dossier submission. Whether it is knowing about dossier requirement or import regulations for their devices, medical devices/IVD company must be aware of all the necessary requirements.

Freyr with an exclusive focus on providing Regulatory Intelligence(RI) solution for device category, assists medical device and IVD companies starting from addressing any focused Regulatory query, overview of any country’s regulations or requirement to assess the Regulatory needs for product registration. Freyr offers customized and reader friendly Regulatory report addressing the major topics a device company must know before entering any market. Regulatory intelligence services span across:

  • Medical device
  • In-Vitro Diagnostics (IVD)
  • Combination product
 

Freyr Expertise

  • Regulatory overview of country
  • Product categorization and classification 
  • Quality Management System (QMS)
  • Registration requirements
  • Labeling and packaging requirements
  • Clinical trial study requirements
  • GxP requirements
  • Import regulations
  • Local agent requirements
  • Post-marketing authorizations
 

Freyr Advantages

  • Skilled and experienced Regulatory professionals
  • Proven expertise in:
    • Regulatory analysis and assessment
    • Regulatory report writing
    • Regulatory secondary research
    • Regulatory primary research