In order to ensure the safety, quality and benefits of the use of Medical Devices and Household Health Supplies (PKRT), the production and distribution processes carried out must meet predetermined standards, as mandated by Health Law Number 36 of 2009 and the standards set by WHO regarding the standards for implementing the Good Manufacturing Practice system (GMP) and the Good Distribution Practice system (GDP).

To meet these standards, the production and distribution process must be supervised and guarded by the Central Government, Local Government and the community which can be carried out in stages according to their authority. As a form of this effort, the Directorate of Medical Device and PKRT Supervision held a meeting on "Strengthening the Supervision of Medical Devices and PKRT in the Regions" which was held online on Wednesday, December 1, 2021 and was attended by representatives from the Directorate General of Regional Development of the Ministry of Home Affairs, representatives of Regional Heads throughout Indonesia, Regional Inspectors throughout Indonesia, Chairpersons of Health Service Associations, Heads of Provincial and Regency / City Health Offices throughout Indonesia.

The purpose of this meeting is to form an understanding and mutual agreement between the Central Government and Local Governments in supervising medical devices and PKRT in accordance with their authority. In addition, it is also necessary to empower and optimize regional officers who have been trained, to be able to play an active role in the supervision of medical devices and PKRT. Supervision of medical devices and PKRT is one of the activities that support the transformation of the health system, especially the transformation of the pharmaceutical and medical device security system to realize quality health services for the community.

With the enactment of the Job Creation Law, Government Regulation Number 5 of 2021 concerning Risk-Based Business Licensing, Minister of Health Regulation Number 14 of 2021 concerning the Implementation of Risk-Based Business Licensing in the Health Sector which provides convenience in business licensing, strengthening the supervision of medical devices and PKRT must be carried out in stages between the central and regional levels in accordance with the Minister of Home Affairs Regulation Number 27 of 2021 which states that Regional Governments must be able to fund and have the authority to supervise medical devices. 

At this meeting, the Director of SUPD III Directorate General of Regional Development, Ministry of Home Affairs, Mr. R. Budiono Subambang said that the Ministry of Home Affairs supports better supervision of the implementation of the authority of the Regional Government regarding Alkes and PKRT, for this reason it is necessary to have a good and up-to-date NSPK to answer the challenges of supervision of Alkes and PKRT so that the community is protected and at the same time their rights to quality Alkes and PKRT are fulfilled. It was also conveyed that the Ministry of Home Affairs' support is open for better collaboration in using its authority or carrying out tasks for general guidance and supervision to the Regional Government in the implementation of regional authority related to Alkes and PKRT.

In line with that, the Chairman of the Healthination Association, Mr. M. Subuh, in his presentation said that health services are the basic needs of the community which have been outlined in SPM and are mandatory regional affairs. The Regional Government (through the Health Office) must be able to ensure the safety and affordability of PKRT by all levels of society. The Health Office plays a role in guidance, supervision, assistance and monitoring and evaluation of all aspects of activities both program and administrative.