Home Work Unit Directorate of Medical Devices Control

Directorate of Medical Devices Control

Task

The Directorate of Medical Devices Control has the task of carrying out the formulation and implementation of policies, formulating norms, standards, procedures, and criteria, providing technical guidance and supervision, evaluation, and reporting in the field of control of medical devices and household health supplies.

Functions

In carrying out the task, the Directorate of Medical Devices Control performs the following functions:

1. preparation of policy formulation in the field of supervision of production and distribution facilities, products, advertising, post border, standardization, certification of good manufacturing practice, good distribution practice for medical devices, invitro diagnostic medical devices, and household health supplies;
2. implementation of policy in the field of supervision of production and distribution facilities, products, advertising, post border, standardization, certification of good manufacturing practice, good distribution practice for medical devices, invitro diagnostic medical devices, and household health supplies;
3. penyiapan penyusunan norma, standar, prosedur, dan kriteria di bidang pengawasan sarana produksi dan distribusi, produk, iklan, post border, pembakuan, sertifikasi cara pembuatan yang baik, cara distribusi yang baik alat kesehatan, alat kesehatan diagnostik invitro, dan perbekalan kesehatan rumah tangga;
4. providing technical guidance and supervision in the field of supervision of production and distribution facilities, products, advertising, post border, standardization, certification of good manufacturing practice, good distribution practice of medical devices, invitro diagnostic medical devices, and household health supplies;
5. investigations in the field of medical device management;
6. monitoring, 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.

Head of Section of Administration
Dra. Nurlaili Isnaini, Apt., M.Kes.