INDONESIA ENFORCES MEDICAL DEVICE LABELING REQUIREMENTS

The new medical device regulations (Permenkes No. 62, 2017, Marketing Authorization of Medical Devices, IVD Devices and Household Goods.) that went into effect on January 12, 2018 include the requirement that the Instruction for Use (IFU) including intended use, contraindications, attentions, and warnings be translated into the local language (Bahasa Indonesia) (ref. Paragraph 41, Clause 6). Implementation of this requirement was to be given a two year grace period (e.g., through January 12, 2020).

However, the Ministry of Health has been requesting the IFU in Bahasa Indonesia starting in March of this year as a supplemental document request for registration applications.  As such, it is recommended that all new device registration applications include the IFU in local language.

At this point, devices with valid registration certificates (AKL) previously issued without IFU in local language, may continue to be imported and sold into the Indonesian market.  Any future amendment to the AKL should include addition of the IFU in Indonesian language. Device manufacturers should still check with their Indonesia license holder for any active AKL certificates to confirm the IFU requirements individually.

Classification of Medical Device

International ClassificationExamplesRisk Level
ACholesterol, uric acid test system
Surgical Instrument; Bandage
Surgical camera; Electric operating table
Patient scale
Low
BPregnancy self testing
Electric Hospital Bed
Surgical Lamp, Surgical Mask
Low – Moderate
CBlood glucose self testing
ECG, X-ray Unit, Syringe
Condom, Contact lens
High – Moderate
DHIV Blood donor screening, Stent
Intraocular lens (IOL), Defibrillator, Pacemaker
High

Asia Actual has a local, licensed office in Jakarta to provide medical device registration, license holding, importing and commercial support services in Indonesia. Please contact us with any questions or support requests.