Indonesia medical device registration is a relatively fast and inexpensive process particularly considering the size of the country. The primary government agency responsible for regulation of medical devices is the Ministry of Health (MoH). The Authority is also charge of pre-market and post market evaluation, standardization, legislation and GMP certification.
Prior to importation, medical and IVD devices must receive a registration number and product license (AKA marketing license) issued by the Ministry of Health to a local, licensed distributor. Reference country approval is required prior to making application for Indonesia medical device registration.
Indonesian regulation (Decree of Ministry of Health No. 62 /2017; article no. 30) provides for amending an existing product license to account for changes in to packaging dimension, packaging size, labeling, and tax ID number. All other product changes would require a new registration submission.
Once issued the product license is valid for 2 to 5 years (depending on the validity period of the Letter of Authorization).
Contact Asia Actual for assistance with Medical Device Regulations in Indonesia.