Directorate of Medical Devices and Household Health Products Evaluation

Tasks

Implementing the policy formulation and implementation, drafting norms, standard, procedure, and criteria, and the granting of technical guidance and supervision, and monitoring, evaluation, and reporting in the field of assessment of medical devices and household health products in accordance with the the legislation.

Functions

  1. preparation of policy formulation in the field of evaluation for medical devices Class A, Class B, Class C, Class D, radiology products, diagnostic products, special medical devices, household health products, and domestic products;
  2. preparation of policy implementation in the field of evaluation for medical devices Class A, Class B, Class C, Class D, radiology products, diagnostic products, special medical devices, household health products, and domestic products;
  3. preparation of drafting norms, standard, procedure, and criteria in the field of evaluation for medical devices Class A, Class B, Class C, Class D, radiology products, diagnostic products, special medical devices, household health products, and domestic products;
  4. preparation of the grant of technical guidance and supervision in the field of evaluation for medical devices Class A, Class B, Class C, Class D, radiology products, diagnostic products, special medical devices, household health products, and domestic products;
  5. monitoring, evaluation, and reporting in the field of medical devices evaluation Class A , Class B, Class C, Class D, radiology products, diagnostic products, special medical devices, household health products, and domestic products; and
  6. implementation of administration and internal affairs of the Directorate.

Officials

Director for Medical Devices and Household Health Products Evaluation
Dr. I Gede Made Wirabrata, S.Si, Apt, M.Kes, MM

Head of Section of Administration
Dual Pump Yettyningsih, S.Farm, Apt., M.Sc

Deputy Director for Class A and B Medical Devices
Nurhidayat, S.Si, Apt

Head of Section of Class A Medical Devices
Eva Zahrah, S.Farm, Apt

Head of Section of Class B Medical Devices
Deni Herdiana, S.Farm, Apt., M.K.M

Deputy Director for Class C and D Medical Devices
Wolves Trilaksono , SF, MM, Apt

Head of Section of Class C Medical Devices
Eva Silvia, SKM

Head Of Section of Class D Medical Devices and Radiology Products
Wahyu Indarto Setyadi, Apt

Deputy Director for Diagnostic and Special Medical Devices
Drag. Tully for you, Apt

Head of Section of Household Health Products
Yellow Lestin Bintari, S.Farm, Apt

Head Of Section of Special Medical Devices
Onne Widowaty, S.Farm, Apt

Head of Section of Domestic and Household Health Products .
Drag. Lili Sadiah Jusuf, Apt

Head of Section of Household Health Products
drg. R. Edi Setiawan, MKM

Head of Section of Domestic Products
Nazmi, Apt