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:

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 Classification	Examples	Risk Level
A	Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale	Low
B	Pregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask	Low - Moderate
C	Blood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lens	High - Moderate
D	HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker	High

Premarket Approval Process

Class A	Class B	Class C	Class 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

Validity	Five Years
Postmarket Surveillance	Sampling, monitoring, and vigilance controls in place.
Timeline	6-12 months
Local Testing	Generally not required
Clinical Studies	Foreign clinical data mostly accepted

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