Indonesia Medical Device Classification: Why Your Korean Class Doesn’t Carry Over

1. Introduction

Hello — this is the INSIGHTOF Consulting team. Since 2016, our Jakarta-based team has completed 1,000+ BPOM certifications, halal certifications, and medical device approvals. If your device fits Indonesian regulations, we get it registered.

We repeatedly meet international teams who assume their home-market class carries over unchanged. The friction is rarely the product itself, it’s misclassification, the wrong registrant, or documents prepared for the wrong dossier.

This page summarizes how Indonesia classifies medical devices, translates that into concrete entry requirements, and gives you a checklist you can use directly in your internal brief.

2. Indonesia’s Class A–D System

Indonesia requires registration of medicines and medical devices under the 2009 Health Law (Article 36). The Ministry of Health (Kemenkes) implements medical device certification through the Directorate responsible for medical devices and PKRT, and Regulation No. 62/2017 sets out categories and basic criteria.

For market-entry planning you must first determine three things: whether the product is a medical device, an in vitro diagnostic (IVD), or PKRT (household health product); the Class (A, B, C, D); and whether the local registrant or partner holds the required authorizations, such as IDAK for distribution of medical devices (ALKES). Classification affects required documentation, who can apply as registrant, and the scope of technical or clinical evidence requested during review.

3. Four Decisions to Get Right Before You File

1) Classification Criteria Differ From Korea

Both systems are risk-based, but detailed criteria are applied differently. Treat classification as a fresh determination for Indonesia, not a translation of your Korean grade.

2) Product Category Can Change the Pathway

Indonesia separates medical devices, IVDs, and PKRT. A product classified as a medical device in Korea may be PKRT or an IVD in Indonesia, and each category follows different technical requirements.

3) Registrant Eligibility Is Class-Dependent

Only a company holding IDAK (medical device distribution license) can register medical devices (ALKES); PKRT may not require IDAK. If you pick the wrong class or category before confirming your local partner’s qualifications, registration will be blocked.

4) A Higher Class Implies Stricter Review

Class A often follows a simpler, notification-like process. Class C and D may trigger requests for clinical evidence, quality management system proof, or on-site responses. Applying for a lower class to shorten review time risks reclassification mid-review and major delays.

4. Where “It’s the Same Class as Korea” Usually Fails

• Submitting the Korean class unchanged on the Indonesian application
• Self-determining class based only on perceived risk, without evidence
• Contracting a partner before verifying IDAK or registrant eligibility
• Treating an IVD as a general medical device and filing the wrong dossier

5. What to Prepare Before Classification & Registration

• Product intended use and indications (clear, evidence-backed)
• Contact with the body: mode, duration, invasiveness
• Power requirements and operational method
• Catalogue and user manual (English acceptable; local language helpful)
• Existing regulatory status and certificates (Korean grade, CE / 510(k) if available)

6. Rule vs. Recommendation

7. FAQs from International Teams

8. Conclusion: Three Things to Do Today

• 1Confirm Indonesia-specific classification (Class A–D) before starting registration.
• 2Determine product category precisely: medical device, IVD, or PKRT.
• 3Verify the local registrant’s qualifications (IDAK for ALKES) before contracting.

Your device’s Korean grade is a useful reference point, not an Indonesian classification. The question is whether your class, category, and registrant are confirmed before you commit to a timeline.