Update: Latest updates on the e-Catalogue enrollment policy can be found here in the updated blog from April 2022.

ENROLLMENT DATES SUBJECT TO DEMAND OF PROCESSING RESOURCES

This month, the Indonesia Ministry of Health began preparations to accept e-Catalogue enrollment applications for medical devices. At a meeting with Gakeslab (the Association of Medical Device and Laboratory Company Organisations), the Ministry of Health and the LKPP (Indonesian Government Goods and Services Procurement Organization) requested members to submit a list of medical devices that license holders intended to submit for e-Catalogue enrollment in 2020. As the ministry did not provide for any new device applications in 2019, the demand for 2020 enrollment is expected to be high. The ministries will now review the level of interest relative to processing resources and decide on the enrollment criteria. Looking back to 2018, there was open enrollment (for all product categories), but the application window was only open for 5 days with no advance notice.

THE E-CATALOGUE APPLICATION PROCESS FOR MEDICAL DEVICES

Interested parties are advised to prepare e-Catalogue applications early and be vigilant for the enrollment announcement. The supporting documents required for the e-Catalogue application can all be drawn from the medical device registration process with two exceptions. First, the application will also require a commercial invoice from one importation into Indonesia. This is to document the landed cost of the device which will anchor the e-Catalogue listing price during MOH price negotiations later in the process. The other new document required is a Certificate of Registration (AKA, Surat Tanda Pendaftaran, or STP Letter) issued by the Indondensia Ministry of Trade in Jakarta. The STP letter application process is involved enough so as to be the gating issue for e-Catalogue application preparation. The required elements include: