Home About Qualtech NEWS INDONESIA: New Regulation Enacted by the Ministry of Health - February 2018
INDONESIA: New Regulation Enacted by the Ministry of Health - February 2018

February 09, 2018

Indonesia's Ministry of Health (MoH) has enacted a new regulation, Permenkes No. 62 Year 2017, concerning Marketing Authorization of Medical Devices, In Vitro Diagnostic Medical Devices and Household Health Supplies on January 13, 2018.

The significant change noticed in this new regulation is the approval timeline. MoH has paved way for quicker registration processes in Indonesia by reducing the evaluation time. Besides, MoH will be no longer be issuing hard copy certificates. The registration certificate will, henceforth, be issued in electronic form and can be printed by applicants or other interested agencies through the Indonesian National Single Window portal, which can be accessed here.

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ID2-Feb18

Furthermore, MoH has also changed their medical device classification to follow the AMDD. Subsequently, medical devices, which are subjected to Indonesian regulations, will be classified into Class A,B,C or D based on their risk level.

   ID3-Feb18

Through the implentation of this regulation, MoH also regulates license transfers. If a manufacturer would like to transfer their license to another distributor, then they are required to issue termination letter to the old distributor or importer and a Letter of Authorization to the newly appointed distributor or importer. The newly appointed party shall notify MoH of this appointment within 30 days from the date of authorization. If the dispute couldn't be settled within 6 months from the date of notification, MoH will automatically deactivate the said license. 

 

Reference:

Enactment of New Regulation by the Ministry of Health, Indonesia

 

 
Home About Qualtech NEWS INDONESIA: New Regulation Enacted by the Ministry of Health - February 2018