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, formulating norms, standards, procedures, and criteria, providing technical guidance and supervision, monitoring, analyzing, evaluating, and reporting in the field of medical device production and distribution.

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 of medical devices, invitro diagnostic medical devices, and household health supplies, medical device distribution facilities, facilitation of exports and imports of medical devices and invitro diagnostic medical devices, and approval of advertising of medical devices, invitro diagnostic medical devices, and household health supplies;
2. implementation of policies in the field of certification of production facilities and products of medical devices, invitro diagnostic medical devices, and household health supplies, medical device distribution facilities, facilitation of exports and imports of medical devices and invitro diagnostic medical devices, and approval of advertising of medical devices, invitro diagnostic medical devices, and household health supplies;
3. preparation of norms, standards, procedures, and criteria in the field of certification of production facilities and products of medical devices, invitro diagnostic medical devices, and household health supplies, medical device distribution facilities, facilitation of exports and imports of medical devices and invitro diagnostic medical devices, and approval of advertising of medical devices, invitro diagnostic medical devices, and household health supplies;
4. providing technical guidance and supervision in the field of certification of production facilities and products of medical devices, invitro diagnostic medical devices, and household health supplies, medical device distribution facilities, facilitation of exports and imports of medical devices and invitro diagnostic medical devices, and approval of advertising of medical devices, invitro diagnostic medical devices, and household health supplies;
5. monitoring, analysis, 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