Medical devices that use wired or wireless technology operating at certain frequencies (such as built-in Bluetooth, wifi, 3G CAM features) require a telecommunication certificate and must be registered with the Ministry of Telecommunication & Information of Indonesia prior to importation.
It is important to register your medical device with the Ministry of Health before the device can enter the Indonesian market. It is also important to check for other necessary registration requirements from other government bodies. For example, any medical device that uses wired or wireless technology operating at certain frequencies (such as built-in Bluetooth, wifi, 3G CAM feature) requires a telecommunication certificate and must be registered for certification at the Ministry of Telecommunication & Information of Indonesia. It is important for the government to regulate all electronic devices and to monitor frequency usage to ensure that new devices do not cause interference with existing medical equipment.
The Ministry will enlist this device for a scheduled field test at an appointed laboratory. A government fee has to be paid for this and it varies according to the type of features being tested. Although your device may have been tested in other countries, it is still required to have it tested locally in Indonesia to receive a telecommunication certificate. It is important that you dispatch a sample of the device with a built-in test mode to your local partner’s address prior to the test. The appointed laboratory must perform the test procedure; however, you may arrange for one of your technicians, or a technician from your local partner, to attend the field test. It is important to ensure that your local partner provides you with complete information to ensure that your medical device complies with all necessary regulations prior to importing the product into Indonesia.