Medical Devices – Registration and Market Access:

  • Developing the optimal regulatory strategy for market entry
  • Evaluating the legal framework and classification of Medical Devices (MD) and In Vitro Diagnostic Devices (IVD)
  • Representing clients with regulatory authorities
  • Registering MD/IVD with regulatory authorities
  • Notifying MD/IVD to INFARMED and managing maintenance
  • Compiling the technical dossier
  • Obtaining CE marking and applying for CNP Code (National Product Code)
  • Evaluating and assisting in the preparation and review of labeling and leaflets
  • Supporting the Responsible Person