Indonesia’s Ministry of Health announced that as of September 2023 certain medical devices will require post-market in-country product testing. While the Ministry of Health explained that initially there is no compulsion to carry out the testing currently, there are rewards for doing so.
Tag Archive for: Indonesia
On April 7th, 2022, the Indonesian Ministry of Health announced a new open enrollment policy allowing manufacturers to list sales prices much easier. Under the new process, listings are accepted upon submission and published online as soon as the next day.
In 2014, the Indonesian Ministry of Health introduced the Good Method of Distribution of Medical Devices (or CDAKB) in order to enforce good distribution practice requirements in the country.
Medical device manufacturers are advised to prepare e-Catalogue applications early and be vigilant for the enrollment announcement. Implementing an optimal pricing strategy will be critical to successful public hospital sales. The e-Catalogue system also increases the importance of independent license holding in Indonesia because there is little room for regional dealer margin under the price scheme.
In response to the overwhelming interest to a June invitation for registered medical device license holder to request inclusion of their device/s in the 2019 e-Catalogue enrollment, the Indonesia Ministry of Health (MOH) has extended the application deadline.
The Indonesian government procurement agency, known as LKPP, has invited medical device companies to apply for any existing e-Catalogue contract extensions by July of 2019