🇮🇩Indonesia Medical Device Regulations

Halal Product Assurance for Medical Devices (BPJPH)

BPJPH halal certification for medical devices. Class A devices by Oct 2026, Class B by Oct 2029, Class C by Oct 2034, Class D by Oct 2039. Non-halal products require clear labeling.

Good Distribution Practice for Medical Devices (CDAKB) Portal

Official CDAKB certification portal. Effective July 1, 2024, CDAKB certificate is mandatory for distributors to register new medical products. MOH audits distributor facilities.

Pharmaceutical and Medical Device Information System

Comprehensive information system for pharmaceutical and medical device regulations, including registration requirements and regulatory updates.

Guidelines for Evaluation of Medical Devices and In Vitro Diagnostics

Official bilingual guidelines (Indonesian/English) for evaluation of medical devices and IVD products during registration process.

Medical Device Registration Portal (Regalkes)

Official online portal for medical device registration, distribution permits, and regulatory submissions to Indonesia Ministry of Health.

Regulation of Minister of Health No. 62/2017 on Medical Device Distribution Permits

Primary regulation governing medical device distribution in Indonesia. Requires all medical devices to obtain Nomor Izin Edar (NIE) distribution permit before sale. Effective January 2018.

Medical Device Classification - ASEAN Harmonized (AHWP Guidelines)

Indonesia follows ASEAN Medical Device Directive (AMDD) classification: Class A (low risk), Class B (low-moderate), Class C (moderate-high), Class D (high risk). Official AHWP document.