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.