The involvement of technologies such as AI, IoT, machine learning, cloud systems, cybersecurity, robotics, and robust communication networks has been apparent in the 4.0 industry. In response to this current development of telecommunication technology, the Indonesian Ministry of Communication and Information Technology (KOMINFO) and the Ministry of Industry socialize the need to apply for SDPPI (Sumber Daya dan Perangkat Pos dan Informatika, en: Directorate General of Resources and Equipment Standardization for Post and Informatics) certification for all telecommunication technology in Indonesia, including medical devices with telecommunication technologies.

In correlation to this requirement, the Indonesian Ministry of Health (ID MoH) strongly recommends manufacturers submit the SDPPI Certification or Certificate of Telecommunication Device for medical devices using telecommunication technologies such as Bluetooth, RFID, etc. under the supporting data during pre-market application to ID MoH. However, if the medical device hasn’t been certified yet, manufacturers can also provide a stamped statement letter stating that Bluetooth or RFID features will be registered with KOMINFO.

The Certificate of Telecommunication Device is issued by the Director of Standardization under the Directorate General of Resources and Equipment Standardization for Post and Informatics (SDPPI) which is one of the work units of KOMINFO. In order to obtain the certification, applicants must submit their application through the OSS website linked to the e-Sertifikasi NextGen. More information on the certification procedure can be found here.

One of the requirements for telecommunication technology or devices is to meet the technical standards according to the regulations and standards. This can be proven by test reports from SDPPI-recognized domestic or overseas labs, which will be submitted during the application for Certification of Telecommunication Device. For the lists of recognized labs for domestic and overseas labs can be accessed through their website (e-Sertifikasi NextGen).

While the current requirement for submitting the Certificate of Telecommunication Device during pre-market application is still in its voluntary phase, there is a possibility that in the near future, ID MoH might determine the above requirements to be mandatory.

 

 

References:

SDPPI Certification Portal Website (e-Sertifikasi NextGen)

Socialization Materials ID MoH – The Need for Certification on Telecommunication Medical Devices