Regulatory Intelligence Consulting Support for an EU Medical Device Manufacturer

Regulatory agency websites, Regulatory Laws, Legislations or Policies, Guidance documents

Concept Papers

Drug Authorities Presentations

For countries or regions where the data was not accessible from initial research, the following approach was taken: – Opinion and advice from Celegence’s internal operations team including publishing, submission, and clinical professionals – Input from local Subject Matter Experts with experience registering devices in the concerned countries – Email correspondence, and telephone enquiries with the concerned Health authorities and local agent The output of the research and analysis was a comprehensive Regulatory Intelligence report with the required information for registration, including local classification, clinical triaL

requirements, import/export requirements, and local representative requirements. The report also included detailed steps for registering the device leveraging the CE mark and hence finding accelerated registration pathways.