ABSTRACT
Penetrating this huge market of medical devices is difficult due to the wide and extensive geographical boundaries in the country. Also, highly bureaucratic medical device import and trading regulations have made it more difficult for foreign manufacturers to enter the market. Indonesia also imposes tariffs of up to 30% on imported medical devices depending on the type, use, and value of these devices.4Indonesia has a centralized healthcare system, headed by the Ministry of Health (Kementerian Kesehatan R.I.). The Ministry of Health purchases most of the medical disposables and hospital equipment for the 900 public hospitals around the country. Due to the highly rigid nature, there is limited budget for most of the hospitals in the country. Recent changes, however, have been encouraging in de-centralizing healthcare services in the country. This will spur the growth of the medical devices market in the country as individual regions collect and plan the healthcare budget individually themselves.4There is a market disparity in the standard of healthcare between rural and urban areas. The capital city, Jakarta, enjoys relatively good levels of primary care as well as a range of modern private specialist facilities, while healthcare coverage in remote regions tends to be insufficient. The majority of the Indonesian medical device market is supplied by imports, which dipped by 1.5% over the previous year to US$ 348.4 million in 2009. Imports have grown at a CAGR of 35.2% in 2005-2009.5 During the 24th ASEAN Consultative Committee on Standards and Quality Meeting on August 3-4, 2004, the formation of a Product Working Group on Medical Device (ACCSQ-MDPWG) was proposed to implement specific measures on medical device under the road map for healthcare integration. This is to be in line with the ASEAN leaders’ decision on the establishment of the ASEAN Economic Community (AEC) by 2020 and fast-track integration of the 11 priority sectors, including the healthcare sector. Therefore, as one of ASEAN member country, Indonesia is committed to the implementation of ASEAN Harmonization in 2014.To welcome it, at this time, Indonesia has some regulations relating to medical devices:
• Ministerial Regulation of Health Republic Indonesia No. 1189/ MENKES/Per/VIII/2010. Production of Medical Devices and Household Device. Issued on August 23rd, 2010.
