The form of the process of acceleration of licensing includes Medical Devices Distribution License, In-Vitro Diagnostic Medical Devices (DIV), PKRT, Recommendation on Importing Medical Devices and PKRT without Distribution License, as well as Approval for the Implementation of Medical Devices Testing in accordance with their authority.
“The flow of relaxation through the ODS mechanism is calculated after the applicant / applicant company has completed the file,” continued Wirabrata.
“Another case, during normal situations, which evaluates the licensing of product distribution permits requires more time. This is because it adjusts to product safety standards, quality and utilization of medical devices and PKRT in accordance with national regulations and / or international regulations.”
Furthermore, Wirabrata stressed, when the COVID-19 pandemic situation was still evaluated in accordance with standards that adequately met the product safety, quality, and utilization benefits of medical devices and PKRT and were given marketing authorization under special circumstances (Emergency Use Autorization).
“The ODS licensing process is also enforced 7 (seven) working days a week and is processed endlessly through a system based online and the approval of the distribution permit that has been digital signature“he stressed.