Regulatory Authority
Directorate of General Pharmaceutical Service and Medical Device
Classification
I, IIa, IIb, III, IV
Quality system
ISO 13485.
Procedure
All medical devices are subject to registration.
Foreign manufacturers intending to market medical devices in Indonesia must appoint a Local Representative responsible for submitting the documents required in the registration procedure to the Directorate of General Pharmaceutical Service and Medical Device.
Applicant
Local Representative
Timeframe and fees
Class I medical devices: 30 days.
Class IIa and IIb medical devices: 60 days.
Class III medical devices: 90 days.
Fees to be paid for device registration vary depending on the device’s risk class.
Validity
5 years
Labeling and documentation language
Documentation and labeling must be provided in English or Indonesian.
Useful information
Indonesia is part of the Association of Southeast Asian Nations (ASEAN). In addition to Indonesia, the following countries are ASEAN members: Philippines, Malaysia, Singapore, Thailand, Brunei, Vietnam, Myanmar, Laos, Cambodia, East Timor.
Foreign manufacturers who intend to market their devices in Indonesia must appoint an Authorized Representative and distributor.