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Medical Devices-Asia and ROW Regulatory News-Jan 2023

  1. Manufacturing of medical devices using 3D printer inside a healthcare facility.
  2. Manufacturing according to the Medical Device Production System (MDPS).
  3. In-House IVD.
  4. All Medical Devices modified or developed within Healthcare facility.

Importers can contact Medical Device Regulations department via [email protected] email for any inquiries. Authorized representatives who intend to add or modify the scope registered in their license can apply online through AJHEZA system.