Home Work Unit Directorate of Medical Devices Production and Distribution

Directorate of Medical Devices Production and Distribution

Task

The Directorate of Medical Device Production and Distribution has the task of formulating and implementing policies, preparing norms, standards, procedures, and criteria, providing technical guidance and supervision, evaluating, and reporting in the field of production and distribution of medical devices and household health supplies.

Functions

In carrying out the task, the Directorate of Medical Device Production and Distribution organizes functions:

1. preparation of policy formulation in the field of certification of production facilities and products, facilitation of exports and imports, approval of advertisements for medical devices, invitro diagnostic medical devices, and household health supplies, and certification of distribution facilities and special access scheme for medical devices and invitro diagnostic medical devices;
2. implementation of policies in the field of certification of production facilities and products, facilitation of exports and imports, approval of advertisements for medical devices, invitro diagnostic medical devices, and household health supplies, and certification of distribution facilities and entry of special access schemes for medical devices and invitro diagnostic medical devices;
3. preparation of norms, standards, procedures, and criteria in the field of certification of production facilities and products, facilitation of exports and imports, approval of advertisements for medical devices, invitro diagnostic medical devices, and household health supplies, and certification of distribution facilities and entry of special access schemes for medical devices and invitro diagnostic medical devices;
4. providing technical guidance and supervision in the field of certification of production facilities and products, facilitation of exports and imports, approval of advertisements for medical devices, invitro diagnostic medical devices, and household health supplies, and certification of distribution facilities and special access scheme for medical devices and invitro diagnostic medical devices;
5. monitoring, evaluation, and reporting; and
6. implementation of administrative affairs of the Directorate.

Board

Director for Medical Devices Production and Distribution
Dede Mulyadi, SKM, M.Kes, CRMP

Head of Section of Administration
Nurul Hidayati, Apt.