This page talks about the overall process of registration in Indonesia by MOH RI

Medical devices have been regulated in Indonesia since 1991. Only a company which has the distribution license (IPAK) issued by the MOH RI (Ministry of Health Republic of Indonesia) can import medical devices. It is important to note that there can be only one legal importer and distributor in Indonesia. Additionally the filing to MOH RI can be done via a e-registration online system which makes the process simple and efficient. The Registration import medical device license has a validity of minimum 2 years and maximum 5 years. Spare parts and accessories do not require registration.

The Regulation Of Medical Devices In Indonesia by MOH RI Is Divided Into Two Main Parts

Part 1: Pre-Market Control

  • Manufacturer License (ISO 13485 for QMS)
  • Distribution License (Good Distribution Practise)
  • Registration License (ASEAN CDST)

Part 2: Post Market Control

The ASEAN AMDD guideline is used for post-market control and includes

  • Sampling
  • Monitoring
  • Vigilance
  • Advertisement

Classification System for Medical Devices in Indonesia

ClassCategoryRisk LevelExamplesLevel of ControlAdministration Fee
IALow riskCholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scaleGeneral Control1500
IIBLow-Moderate riskPregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical MaskSpecial Control3000
CModerate-High riskBlood glucose self testing, ECG, Xray Unit, Syringe, Condom, Contact lens
IIIDHigh riskHIV Blood donor screening, Stent, Intra ocular lens (IOL), Defibrillator, PacemakerPre Market Approval5000

Key Document Requirements for Medical Device Registration in Indonesia (MOH RI)

  • Executive Summary with a brief on marketing history, Intended uses and indications, regulatory clearances and pending approvals in other countries and important safety or performance information
  • Essential Principles Checklist
  • Declaration of Conformity
  • Device Description
  • Design Verification and Validation
  • Device Labeling
  • Risk Analysis
  • Manufacturer Information

Label, IFU, Brochure/Leaflet and Manual Book of Medical Device

  • Labeling of the product packaging
    • Enclosed the figure,
    • Product name,
    • Manufacture name & address
    • Registration no,
    • Batch No /Lot No,
    • Warning with Symbol/logo, Indonesian or English language
  • Manual book and IFU should be provide in original language and Indonesian language
  • Brochure/leaflet with Indonesian and/or English language

Special Requirements

HIV ProductsShould be tested at the Indonesia Reference National Laboratory Hospital (RSCM)
Menstrual Pads and Adult Diapers, Condom, syringeShould have fluorosence tested at the Indonesia National Laboratory (Sucofindo, The Food and Drug Monitoring Agency/BPOM)
For the product contain animal origin as its raw material (ex: catgut)Should have certificate of free Disease form the product country of origin
For the product radiation (ex: X-ray unit)Should have safety radiation certificate from National Nuclear Agency
Open SoftwareSoftware Validation report From Manufacture or independent laboratories

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