Indonesia Medical Device Regulations

Agency
All medical devices are regulated by the Ministry of Health (MOH).
Medical Device Definition
Medical devices are instruments, apparatuses, machines and/or implants that do not contain medicines used to prevent, diagnose, cure and relieve diseases, treat sick people, recover human health and/o r form structures and correct the body function. Based on the objective of use as meant by the producer, medical devices may be used individually or in combination for human beings with one or several purposes as follows:
  1. Diagnosis, prevention, monitoring, treatment or reduction of diseases;
    1. Diagnosis, prevention, monitoring, treatment or reduction of diseases;
    2. Diagnosis, monitoring, treatment, reduction or compensation of sick condition;
    3. Investigation, replacement, modification, anatomical support, or physiological process;
    4. Support or maintain life;
    5. Obstruct fertilization;
    6. Disinfectant of medical devices;
    7. Provide information for medical or diagnosis purposes through the in vitro test on the specimen and human body
Classification of Medical Device
International ClassificationExamplesRisk Level
ACholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scaleLow
BPregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical MaskLow - Moderate
CBlood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lensHigh - Moderate
DHIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, PacemakerHigh
Premarket Approval Process
Class AClass BClass CClass D
Apply for Distributor's license
Once Distributor's license is received, company must apply for Medical Device Registration
Complete Common Submission Dossier Template (CSDT)
Provide ISO 13485 for QMS
If approved, MOH will grant registration.
Additional Information
ValidityFive Years
Postmarket Surveillance Sampling, monitoring, and vigilance controls in place.
Timeline6-12 months
Local TestingGenerally not required
Clinical StudiesForeign clinical data mostly accepted
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