🏥 ASEAN Medical Device Directive

Medical Devices Classification

Risk-based classification system (Class A-D) following ASEAN Medical Device Directive principles. This framework determines registration requirements, quality assurance levels, and post-market surveillance obligations for medical devices in Indonesia.

Medical Device Risk Classification Overview

Class	Risk Level	Description	Key Examples	Registration
Class A	Low	Low Risk Medical Devices Non-invasive devices with minimal risk to patient safety	Film viewerSurgical instruments (reusable)Surgical gloves+9 more	AKL (Alat Kesehatan Luar) - Notification
Class B	Low-Medium	Low-Medium Risk Medical Devices Devices with low to moderate risk potential	Blood pressure cuffSteam sterilizerDigital thermometers+8 more	AKL (Alat Kesehatan Luar) - Full Registration
Class C	Medium-High	Medium-High Risk Medical Devices Invasive devices or those with significant risk to patient safety	Patient monitorX-Ray machinesSurgical instruments+9 more	AKL (Alat Kesehatan Luar) - Enhanced Registration
Class D	High	High Risk Medical Devices Life-sustaining or life-supporting devices with highest risk potential	Heart stentPacemakerDefibrillators+7 more	AKL (Alat Kesehatan Luar) - Comprehensive Registration

Interactive Classification Tool

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Medical Device Classification

Answer the following questions to determine the correct medical device classification

💡 Tip: This interactive tool implements the ASEAN Medical Device Directive classification rules as specified in the Indonesian Ministry of Health guidance document. For complex devices or edge cases, consult with regulatory experts.

Search classes

Risk Classification

4 of 4 classes

Key Information

Framework

ASEAN Medical Device Directive

Authority

Kemenkes / MoH

Registration Type

AKL (Alat Kesehatan Luar)

Classification Basis

•Risk level assessment
•Invasiveness of device
•Duration of contact
•Body system affected

Risk Level Guide

Class ALow

Class BLow-Medium

Class CMedium-High

Class DHigh

Key Definitions

Active Medical Device

Device operated by electrical energy or energy source other than human body or gravity

Invasive Device

Device that penetrates into the body wholly or partially through body orifices or body surface

Duration Categories

•Temporary: Continuous use <60 minutes
•Short-term: 60 minutes to 30 days
•Long-term: >30 days continuous use

Classification Factors

•Duration of contact with the body

•Degree and location of body invasion

•Combination with other medical devices

•Intended use for diagnosis or maintenance

•Local vs systemic effects

•Mechanism of action in the body

•Biological effects on the body

Related Resources

→ regalkes.kemkes.go.id → Ministry of Health Indonesia

Official medical device registration and guidance resources