Regulatory Authority
Directorate of General Pharmaceutical Service and Medical Device
Classification
I, IIa, IIb, III, IV
Quality system
ISO 13485:2016
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 Directorare 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
Licence: 5 years
Labelling and documentation language
Documentation and labelling 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.
