Home Work Unit Directorate of Medical Devices Control

Directorate of Medical Devices Control

Task

The Directorate of Medical Device Control 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 control.

Functions

In carrying out its duties, the Directorate of Medical Device Control carries out functions:

1. preparation of policy formulation in the field of supervision of production and distribution facilities, products, advertisements, outside the customs area (post border), certification of good manufacturing methods, good distribution methods of medical devices, invitro diagnostic medical devices, and household health supplies, as well as security of medical devices and facilities;
2. Implementation of policies in the field of supervision of production and distribution facilities, products, advertising, outside the customs area (post border), certification of good manufacturing methods, good distribution methods for medical devices, invitro diagnostic medical devices, and household health supplies, as well as security of medical devices and facilities;
3. preparation of norms, standards, procedures, and criteria in the field of supervision of production and distribution facilities, products, advertisements, outside the customs area (post border), certification of good manufacturing methods, good distribution methods of medical devices, invitro diagnostic medical devices, and household health supplies, as well as security of medical devices and facilities;
4. providing technical guidance and supervision in the field of supervision of production and distribution facilities, products, advertising, outside the customs area (post border), certification of good manufacturing methods, good distribution methods for medical devices, invitro diagnostic medical devices, and household health supplies, as well as security of medical devices and facilities;
5. investigations in the field of medical device management;
6. monitoring, analysis, evaluation, and reporting; and
7. implementation of administrative affairs of the directorate.

Board

Director for Medical Devices Control
Dra. Eka Purnamasari, Apt., M.K.M.