“To ensure that medical devices and household health supplies (PKRT) circulating in the community meet the standards and requirements, it is necessary to conduct pre and post-market medical devices and PKRT in circulation. This is important to protect public safety,” said Director of Medical Device Production and Distribution drg. Arianti Anaya, MKM in the opening speech of the Socialization of E-System Licensing and Supervision of Medical Devices and PKRT held on Wednesday, March 12, 2014 at The Bridge Hotel Aston Rasuna, Jakarta.

In order to achieve optimal health status for the community in relation to medical devices and PKRT is the availability of medical devices and PKRT in sufficient quantities, quality, safety and usefulness and affordable by the community.

In the era of free trade where the demands of the community are so high for the need for medical devices and PKRT, it opens up great opportunities for business people. As we all know, there are currently a lot of medical devices and PKRT, both local and imported, circulating in the territory of Indonesia.

In order to ensure the safety, quality and benefits of medical devices and PKRT circulating in Indonesia, the Directorate of Production and Distribution of Medical Devices strives to jointly realize the guidance, supervision and control of medical devices and PKRT in order to meet health service needs.

In this activity, the e-System of Licensing and Supervision of Medical Devices and PKRT was introduced, which includes e-infoalkes, e-watch of medical devices and PKRT, and e-report of medical devices and PKRT.

In the context of bureaucratic reform, the Directorate General of Pharmaceuticals and Medical Devices of the Ministry of Health carries out information system development activities that can improve performance and services to the community, namely by developing a web-based information system to find out licenses that have been issued through the Online Registration System called the E-Infoalkes System. E-Infoalkes.

The users of this E-Infoalkes portal are the Ministry of Health, Producers and Distributors of ALKES & PKRT and the general public who want to know information about ALKES and PKRT licenses that have been issued and know the profile of companies engaged in ALKES and PKRT.

Meanwhile, to protect the public against the circulation of medical devices that do not meet the requirements for safety, quality and benefits, it is necessary to increase the supervision of medical devices that must be carried out in health service facilities and those circulating in the community.

To make it easier for health workers, Health Care Facilities and the public to report on medical devices that do not meet the requirements, the e-Watch Medical Devices & PKRT (e-Watch Alkes) is a national monitoring system for medical devices that do not meet the requirements. This system is also an Alert System, which is open information on medical devices that can cause harm to patients, health workers and or the public and can be easily accessed by the public.

The e-Watch Alkes application is expected to detect early vigilance in the form of handling complaints from the public/users, reporting of Adverse Events (AEs) by Medical Device Manufacturers and Distributors, and Field Safety Corrective Action (FSCA).

Meanwhile, the e-Report Application for Medical Devices and PKRT was built to facilitate the reporting of the results of production and distribution of Medical Devices by Manufacturers or Distributors of Medical Devices, as well as reporting the results of production or import of Household Health Supplies (PKRT) by manufacturers or importers of PKRT.

This application is a recapitulation of the circulation of medical devices and PKRT at home / abroad and is expected to be able to trace if there are complaints about the use of medical devices and / or PKRT.