ABSTRACT
Indonesia, with a population of more than 220 million, is a medical device market that has a large potential. Indonesia has a centralized healthcare system, headed by the Ministry of Health. 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. Medical devices in Indonesia are regulated by the Ministry of Health of the Republic Indonesia; Directorate of General Pharmaceutical Service and Medical Device; and so on. All medical devices with each code should be registered with the Ministry of Health before they can be freely imported, distributed, and sold in the market. The product license issued by the Ministry of Health will be effective for five years or in accordance with the term of validity of the letter of appointment. Post-market surveillance mechanisms are required to monitor the medical devices already in the market.
