Business Imperatives

  • A South Korean medical AI software company had two CAD software they intended to use for the evaluation of chest radiography and mammography images.
  • The SaMDs were moderate-risk; approved by the MFDS, Korea; and CE-marked, in compliance with the EU MDD.
  • The customer was moving toward aggressive expansion in multiple countries spread across various ASEAN, MENA, and LATAM regions.


  • Fourteen (14) country-specific RI reports had to be prepared.
  • Regulatory information on the sole license holder policy for 22 countries had to be done.
  • End-to-end device registration had to be supported in the target countries.
  • AR services were to be provided in the target countries.

Problem Statement

  • There was a lack of SaMD regulations in most of the target countries.
  • Each software had diverse priorities and required specific expansion plans.
  • Translation of documents was required for specific countries.
  • Deliverables were complex due to multiple products, services, and countries involved.
  • Compilation of technical dossiers, as per respective HA requirements, was to be initiated.

Freyr Solutions and Services

Freyr Solutions and Services
  • Tailored RI reports for 14 countries, providing insights into local Regulatory requirements and compliance standards.
  • Gathered detailed Regulatory information for 22 countries on the sole license holder policy to ensure compliance.
  • Registered CAD software for chest radiography, facilitating market entry and Regulatory compliance in target regions.
  • Acted as AR, ensuring legal compliance and serving as a point of contact with the respective Regulatory authorities in each market.
  • Phase I: Meticulously crafted country-specific Regulatory Intelligence (RI) reports for 14 nations and gathered query-specific details on chest radiography software for 22 countries.
  • Phase II: Provided AR support for chest radiography software in Malaysia and South Africa, ensuring compliance and facilitating smooth market entry.
  • Phase III: Expanded our AR services and facilitated registration for chest radiography software in multiple countries, including Chile, Philippines, Argentina, Hong Kong, Saudi Arabia, Colombia, Thailand, Turkey, Russia, and El Salvador. Initiated the RI report for mammography software, ensuring parallel progress and efficient utilization of resources.
  • Phase IV: Provided AR services and facilitated the registration of mammography software in Egypt, Malaysia, Hong Kong, Colombia, Argentina, Saudi Arabia, South Africa, and Kenya, further solidifying our commitment to comprehensive Regulatory support across diverse markets.
  • A detailed understanding of medical device regulations was provided to the various target countries.
  • Timely and accurate classification and registration of software was done for each of the target markets.
  • A one-stop solution was provided for all Regulatory needs.
  • There was hassle-free communication along with continuous project tracking.
  • The end-to-end device registration process was successfully completed.
  • In-depth guidance on device registration processes in the target countries was provided.
  • Registration of products in multiple countries was simplified with LR support.
  • Served as a single service provider for various services across multiple countries situated in different regions.