Analysis of Preparedness for the Implementation of Simplified System and Permission Process in the Development of Medical Devices


Pritha Elisa1), Dumilah Ayuningtyas2)

 

1)Masters Program in Public Health, Universitas Indonesia

2)Health Policy and Administration Department, Faculty of Public Health,

Universitas Indonesia

 

ABSTRACT

Background: In the health national insurance (JKN) era, the need for medical devices was fulfilled by more than 90% of imported products. Therefore, the government issued the Mi­nis­ter of Health Regulation No. 17 of 2017 concerning the action plan for the de­ve­lopment of the pharmaceutical industry and medical devices. This study aimed to de­termine the pre­pared­ness for the implementation of simplified system and per­mission process in the deve­lop­ment of medical devices.

Subjects and Method: This was a qualitative study conducted in July 2019. The key informants were officials from the ministry of health directorate of medical devices and household health supplies evaluation and supervision. The informants were also people from the Indonesian Association of Medical Device Manufacturers. The study theme was pre­pa­red­ness for the implementation of simplified system and permission process in the develop­ment of medical devices. The study variables included the size and ob­jec­tive of the policy, re­source, characteristics of the implementing agency, com­munication between organization, disposition of implementer, as well as the social, economic, and po­litical environment. The data were collected through in-depth interview and ob­ser­vation and analyzed descriptively.

Results: Preparedness for the implementation of simplified system and permission pro­cess in the development of medical devices based on Minister of Health Regulation No. 17 of 2017 was quite good. The size and objectives of the implementation policy were clear enough. The available resources were sufficient and qualified. Standard ope­ra­tional procedure (SOP) had been prepared and applied to the system. Policy com­munication had gone well. Implementer dis­position in addressing policies was optimal. The economic, social and political environ­ment had a significant influence on policy implementation.

Conclusion: Preparedness for the implementation of simplified system and per­mis­sion pro­cess in the development of medical devices has been running well in terms of variable size and policy objective, resource, implementing agency characteristic, com­munication between organization, implementing disposition, and the social, eco­nomic, and political environment.

Keywords: medical device, licensing, implementation, policy, domestic

Correspondence: Pritha Elisa. Masters Program of Public Health, Faculty of Public Health, Universitas Indo­nesia, Depok, West Java, Indonesia. Email: pritha.elisa@gmail.com Mobile: 085­692877460.

DOI: https://doi.org/10.26911/the6thicph-FP.04.31

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