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 makeing applicatoin for Indonesia medical device registration.
Medical device definition and classification in Indonesia closely follow GHTF guidelines and are being harmonized according to the ASEAN Medical Devices Directive (AMDD). That is to say, the country participates in ACCSQ-MDPWG (Asean Conformity Committee for Standard and Quality Medical Devices product Working Group) has adopted the ASEAN Medical Device Directive to be adjusted and implemented into the regulation of medical and household devices in Indonesia.
Official guidance on timelines and fees for the processing of a Class A medical or IVD device application is 15 days and approximately US$115 (Indonesian Rupiah 1,500,000). Class B and C medical and IVD devices require 30 days and US$230 (Indonesian Rupiah 3,00,000). Class D devices are processed in 45 days for a fee of US$340 (Indonesian Rupiah 5,000,000).
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 if valid for 2 to 5 years (depending on the validity period of the Letter of Authorization).
Contact Asia Actual for assistance with Medical Deivce Regulations in Indonesia.