Question 1

What is Indonesia's MOH and why is it important for medical device manufacturers?

Accepted Answer

Indonesia's Ministry of Health (MOH), specifically the Directorate General of Pharmaceutical and Medical Devices, is the regulatory authority responsible for medical device safety, quality, and market authorization. The MOH enforces regulations through Health Minister Regulations (Permenkes) and oversees the product registration (Izin Edar) system. All medical devices marketed in Indonesia require Izin Edar approval, and foreign manufacturers must work with licensed Indonesian distributors holding API-U licenses. Indonesia is actively implementing ASEAN Medical Device Directive (ASEAN MDD) harmonized requirements.

Question 2

What is Izin Edar and what are the requirements?

Accepted Answer

Izin Edar is the product registration certificate required for all medical devices marketed in Indonesia. Requirements: Device classification (Class A, B, C, or D per ASEAN MDD), Indonesian distributor with valid API-U license, manufacturer quality certificate (ISO 13485 or equivalent), free sale certificate from country of origin, conformity certificate (CE marking, FDA approval, etc.), technical documentation (device description, intended use, labeling, instructions for use in Bahasa Indonesia), product samples for evaluation (may be required for certain devices). Process: Application submitted by Indonesian distributor via MOH online system (SISPRODUK), technical review by MOH (timeline varies by class: 20-90 working days for complete applications), upon approval, Izin Edar issued with 5-year validity (renewable). Higher class devices face more extensive review and may require additional clinical or performance data.

Question 3

What is API-U and why is it required?

Accepted Answer

API-U (Alat Kesehatan dan Perbekalan Kesehatan Rumah Tangga - Import License for Medical Devices and Household Health Supplies) is the distributor license required for companies to import and distribute medical devices in Indonesia. Key Points: Only entities with valid API-U licenses can apply for Izin Edar, foreign manufacturers cannot directly register devices - must partner with Indonesian API-U holder, API-U license issued by MOH to qualified Indonesian distributors/importers, license requires qualified personnel, appropriate facilities, and quality system. Implications for Foreign Manufacturers: Must identify and appoint qualified Indonesian distributor with API-U, distributor becomes the regulatory owner of Izin Edar, careful distributor selection critical for market access and long-term partnership. Changes in distributor require Izin Edar transfer or re-registration.

Question 4

How does Indonesia classify medical devices?

Accepted Answer

Indonesia follows the ASEAN Medical Device Directive (ASEAN MDD) risk-based classification system: Class A: Low risk (e.g., non-invasive devices with minimal body contact), Class B: Low-medium risk (e.g., channeling or short-term invasive devices), Class C: Medium-high risk (e.g., long-term invasive, active therapeutic), Class D: High risk (e.g., implantable, life-sustaining, drug-device combinations). Classification is based on: invasiveness, duration of body contact, whether device is active, intended purpose and critical therapeutic nature, interaction with circulatory system or drugs. ASEAN MDD alignment facilitates regional harmonization and acceptance of international certifications. Higher class devices face longer review timelines and more stringent evidence requirements.

Question 5

What is ASEAN MDD and how does it affect Indonesia?

Accepted Answer

The ASEAN Medical Device Directive (ASEAN MDD) is a regional harmonization initiative to align medical device regulations across ASEAN member countries. Key Features for Indonesia: Harmonized classification system (Class A-D), common essential principles for safety and performance, recognition of international standards (ISO, IEC), conformity assessment procedures aligned with global practices, facilitation of mutual recognition among ASEAN countries. Benefits for Manufacturers: Consistent regulatory framework across Southeast Asia, easier regional market access with aligned documentation, increased acceptance of CE marking and international certifications, reduced regulatory burden compared to country-specific systems. Implementation Status: Indonesia actively implementing ASEAN MDD through Permenkes regulations, ongoing refinements and guidance issuance, manufacturers should align documentation with ASEAN MDD essential principles.

Question 6

What quality certificates does Indonesia MOH accept?

Accepted Answer

The MOH requires manufacturers to demonstrate quality management system compliance for Izin Edar registration. Acceptable Quality Certificates: ISO 13485 certification (most common and preferred), CE marking certificate (indicates ISO 13485 compliance), FDA establishment registration and device listing, WHO-GMP certificate, free sale certificate from country of origin (mandatory in addition to quality certificate). Certificate Requirements: Must be current and valid, issued by accredited certification body, cover the specific manufacturing site(s), include the device models being registered. Conformity Certificates: CE marking, FDA 510(k)/PMA, TGA, Health Canada approval, other internationally recognized approvals strengthen applications. ISO 13485 is strongly recommended as the foundational quality certificate for Indonesian market access.

Question 7

How often is Indonesia MOH regulatory news updated and how can I stay informed?

Accepted Answer

Indonesia's MOH regularly publishes Permenkes (Health Minister Regulations), guidance documents, and policy updates related to medical device registration, ASEAN MDD implementation, and post-market requirements. Recent focus includes digitalization of the registration system (SISPRODUK), enhanced post-market surveillance, and regional harmonization. Our platform aggregates daily updates from 7 premium commercial sources including RAPS, Emergo by UL, Asia Actual, and Citeline. We recommend checking this page regularly and working closely with your Indonesian distributor (API-U holder) to monitor MOH announcements.

Question 8

What commercial sources does this platform use for Indonesia news?

Accepted Answer

We aggregate Indonesian regulatory intelligence from 7 premium sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Pacific Bridge Medical, Asia Actual, Pure Global's proprietary research, and Qualtechs. These sources provide expert analysis, real-time updates, and strategic insights beyond basic MOH announcements, helping you navigate Izin Edar registration, API-U distributor selection, ASEAN MDD compliance, and quality certification requirements.

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