The Strategic Objective of the Pharmaceutical and Medical Devices Program in the 2015-2019 Strategic Plan is to increase access, independence and quality of pharmaceutical preparations and medical devices.
Medical devices and Household Health Supplies (PKRT) as part of the target program are considered to have an important role in supporting the achievement of the Health Development Program or Healthy Indonesia Program, especially the pillars of strengthening health services and National Health Insurance. In addition to human resources and drugs, medical devices are one of the important components in health care facilities that affect access and quality of health services provided, including patient satisfaction and safety. Therefore, medical devices in health care facilities must be complete and their condition and function must be in good condition so that they can support health services.

The independence of medical devices and the guarantee of medical devices and PKRT products that meet the requirements in circulation must be realized with comprehensive and sustainable efforts through controlling the life cycle of medical devices, which means that from the time the medical device is designed, produced, distributed, until it is received and used and not reused (disposal), the medical device must remain under control of its safety, quality and benefit requirements.

The Ministry of Health through the Directorate General of Pharmaceuticals and Medical Devices has had roles/tasks related to efforts to control medical devices from pre market to post market through assessment and supervision activities, including assessment of medical devices before circulation (distribution permits), fostering the development of domestic medical device products, certification of medical device and PKRT production facilities, certification of medical device distribution facilities, CPAKB/CPPKRT/CDAKB audits, supervision (inspection) at production and distribution facilities and product supervision (sampling, supervision of advertising and marking).

This control effort is not only the responsibility of the Directorate General of Pharmaceuticals and Medical Devices, but also the joint responsibility of all relevant parties according to their authority, including at the user level (fasyankes) by strengthening the Health Technology Assessment (HTA) and its implementation in the selection of medical devices and good management starting from planning, budgeting, procurement, storage and distribution, as well as maintenance and elimination. For this reason, users must have good standard operating procedures and understand regulations including the provisions for selecting medical devices that have met the requirements or distribution permits. Thus, control of medical devices in accordance with the medical device cycle can be achieved.

Supervision of medical devices and PKRT as part of health resources and part of the factors that support health efforts, is very important to protect the public from medical devices and PKRT that do not meet the requirements, which are very risky to health or safety.

To optimize the implementation of medical device supervision activities, competent supervisory personnel are needed. The Directorate General of Pharmaceuticals through the Directorate of Medical Device and PKRT Supervision has facilitated efforts to improve the ability of supervisory personnel through the “Training on Supervision of Sterile Non Electromedical Medical Devices and In Vitro Diagnostic Medical Devices in Medical Device Production and Distribution Facilities” which was held on September 17 to 21, 2019 at Java Paragon Hotel & Residences, Surabaya.

The activity which was attended by 36 regional participants consisting of the person in charge of the medical device and PKRT program from 22 Provincial Health Offices and 14 Regency / City Health Offices in Indonesia, and 21 central participants was officially opened by the Director of Medical Device and PKRT Supervision, Ir. Sodikin Sadek, M.Kes.

The training aims to improve the knowledge and skills of supervisory personnel, especially those who have been trained in supervision of medical device production and distribution facilities before, especially on the quality management system of sterile non-electromedical medical devices and in vitro diagnostics. Thus, it is expected that supervisory personnel will be able to identify deficiencies or obstacles in the quality management system of sterile non-electromedical medical devices and in vitro diagnostic medical devices in medical device production and distribution facilities and be able to provide guidance to them to comply with safety, quality and benefit requirements.