The Trial of Integration of the Medical Device Licensing System and HouseHold (Regalkes) has been carried out by the Directorate of Medical Device Assessment. And the results of the trial there are no obstacles in making a permit ID for new applications for imported Medical Devices and HouseHold, and making a permit ID for new applications for permits for domestic Medical Devices and HouseHold.
The procedure for applying for a distribution permit through the RBA OSS and PB UMKU LIST is below.

REGALKES INTEGRATION TRIAL

• PELAKU USAHA Login ke :OSS menggunakan username dan password OSS RBA lalu mengajukan permohonan PB UMKU ke KEMENTRIAN INVESTASI/BKPM
• Setelah Pemenuhan Persyaratan PB UMKU di Sistem K/L PELAKU USAHA membuat draft permohonan dan melakukan pembayaran PNBP di REGALKES
• Jika telah mendapatkan Persetujuan PB UMKU Pelaku Usaha Dapat Download Sertifikat PB UMKU di :OSS
• Jika telah mendapatkan Penolakan PB UMKU Pelaku Usaha Dapat Download Surat Penolakan PB UMKU di :REGALKES

EXTEND, CHANGE, ENHANCE AND CHANGE

• Login menggunakan username dan password REGALKES
• Making a draft of an application for an extension, amendment, extension with changes and payment of PNBP
• Evaluation process
• Issuance of Circulation Permit for Medical Devices and HouseHold

If you don't know how to apply for a distribution permit at OSS RBA, you can follow the steps below:

PROCEDURE FOR APPLYING CIRCULATION LICENSE THROUGH OSS RBA
(1). OSS Login Using OSS RBA username and password, if you don't have an account yet, you can REGISTER AT OSS REGISTERSelect PG-UMKU at the top and click on NEW APPLICATION. Choose the KBLI that is in accordance with the UMKU permit that you are going to apply for. (3) You can view data related to KBLI on the websitehttps://oss.go.id/informasi/umku(4) After finding the appropriate KBLI, click the UMKU Business Licensing Process button, Click Apply for UMKU Business Licensing, Select the type of licensing to be processed. (5). After the distribution permit for domestic medical devices has been successfully made, select the button Fulfillment of PB UMKU Requirements in the K/L System. (6). After that, it will be directly connected to the website REGALKES. Finished REGALKES. Finished