Introduction to Medical Device Registration in Indonesia
Introduction to Medical Device Registration in Indonesia This article deals with the Medical Device Registration in Indonesia. The Ministry of Health Republic of Indonesia (MOH RI) is the authority to issue the Certificate for the Medical Devices. Regulation of Medical Devices started in Indonesia in 1991 to ensure the safety quality, performance efficiency, affordability and […]
Regulation of CT Equipment, All Implantable Devices, MRI etc – New Rule
The CDSCO brought about a new amendment on 18th April, 2021 wherein all the following devices will be effective from 1st April, 2021. All Implantable Devices CT Scan Equipment MRI Equipment Defibrillators PET Equipment Dialysis Machine X-Ray Machine Bone Marrow Cell Separator All the manufacturers importing the above mentioned, need to get the import license […]