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Regulatory Authority

Directorate of General Pharmaceutical Service and Medical Device

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Classification

I, IIa, IIb, III, IV

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Quality system

ISO 13485.

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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.

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Applicant

Local Representative

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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.

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Validity

5 years

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Labeling and documentation language

Documentation and labeling must be provided in English or Indonesian.

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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.

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