One of the most critical missteps foreign manufacturers make when entering Indonesia is treating medical device risk classification as a mere administrative box to tick. It is surprisingly common for companies to copy a classification directly from a foreign reference market, assume Kemenkes will simply align, and only realize their mistake after budgets and launch dates are already locked in.
Classifying a device is not just about paperwork, it dictates the weight of your local testing requirements, and the gap between risk tiers can be staggering. We saw this firsthand with a client registering a tuberculosis (TB) diagnostic kit: because of its class, the product faced an exponentially stricter testing scope than lower-risk devices. Knowing how to navigate these boundaries upfront determines whether your approval timeline stretches indefinitely and whether your team gets hit with massive, unbudgeted laboratory costs in Indonesia.
This guide breaks down how Indonesia’s Class A through D system actually operates downstream, how local testing scales across classes, and how getting your classification right early protects your market entry timeline.
What Is Medical Device Risk Classification in Indonesia?
Medical device risk classification in Indonesia places each device into Class A, B, C or D based on the risk it poses to patients and users. Class A is low risk, Class B low to moderate, Class C moderate to high, and Class D high risk.
This four-tier medical device risk classification was set out in Minister of Health Regulation (Permenkes) No. 62/2017, issued by the Ministry of Health (Kemenkes). The ministry’s classification guidance applies it to devices and in vitro diagnostic (IVD) products.
For IVD products, the classes weigh individual risk and public health risk together. That is why a test for an infectious disease is not assessed like a simple low-risk accessory.
Table 1. Medical device risk classification at a glance
| Class | Risk level (Permenkes No. 62/2017) | Typical downstream effect, in our experience |
|---|---|---|
| A | Low | Lightest review path, though the class still needs checking against intended use |
| B | Low to moderate | Documentary review dominates; testing needs depend on the device type |
| C | Moderate to high | Deeper evidence and a real chance of local testing that needs early scoping |
| D | High (for example cardiac stents and pacemakers) | Heaviest evidence expectations; test and clinical scope must be planned before budgeting |
Which Regulations Govern Medical Device Risk Classification Today?
The legal base is Law No. 17 of 2023 on Health, enacted by the Republic of Indonesia, and Government Regulation (PP) No. 28 of 2024, issued by the President, which implements it.
Permenkes No. 5/2026 on Health Supplies, set by the Ministry of Health on 17 April 2026 and promulgated on 4 May 2026, now regulates the circulation of medical devices and replaces Permenkes No. 62/2017.
It also provides a route to submit classification changes. Because the regulation is recent, the exact medical device risk classification provisions and transitional rules should be confirmed by a qualified regulatory specialist before any filing decision.
Permenkes No. 63/2017 on Good Clinical Trial Practice for Medical Devices (CUKAKB, Cara Uji Klinik Alat Kesehatan yang Baik) linked clinical investigation to Class C, Class D and novel devices. Permenkes No. 5/2026 revoked most of its articles. Which provisions remain needs expert confirmation.
How Medical Device Risk Classification Drives Every Downstream Step
In practice, medical device risk classification behaves like the first domino. Once medical device risk classification is set, the review pathway, evidence file, fees and testing scope all follow, so an error at this stage multiplies later.
Medical Device Risk Classification, Evidence and Fees
The ministry’s guidance states that the non-tax state revenue (PNBP) charged follows the risk and class selected by the applicant. A wrong medical device risk classification therefore affects cost before any test begins.
In our experience, higher classes also demand a deeper technical file, including stronger performance and safety evidence. Teams that plan around the wrong medical device risk classification, such as Class B evidence for a Class C device, usually restart parts of the dossier.
Medical Device Risk Classification and Local Testing Cost
This is where medical device risk classification hurts most when mishandled. In our experience, the difference in local testing between classes is substantial, and the TB product mentioned earlier is the clearest case we have handled.
That client’s product needed far stricter local testing than lower-class products would. Because laboratory work in Indonesia is expensive, discovering that scope late can add very large unplanned cost.
Navigation skill separates smooth projects from slow ones: determining the class precisely, then defining the test scope precisely. Both calls rest on regulatory judgement, not on the label printed on a foreign certificate.
Medical Device Risk Classification and Timeline Risk
We do not quote fixed durations, because they vary by product and review queue. In our experience, though, projects slow down most when medical device risk classification is challenged mid-review, since the evidence file and test plan may need rebuilding.
Medical Device Registration in Indonesia: Where Classification Fits
Medical device registration in Indonesia starts with the intended use, then the class, then an evidence file and test plan that match that class. Rushing the medical device risk classification step is what most often causes rework.
- Define the device, its intended use and any IVD function.
- Assign the class through medical device risk classification under the applicable Kemenkes rules.
- Match the technical file and test plan to that class.
- Submit through the Kemenkes registration system.
- Prepare distribution and post-market obligations.
Each step involves judgement calls that a checklist cannot settle. Our guide to the Process of registering medical devices in Indonesia covers the full journey, and Product Registration Indonesia’s medical device registration service supports each stage.
Indonesia Medical Device Market Access Strategy: Classify Before You Budget
An Indonesia medical device market access strategy should begin with medical device risk classification, not price lists or distributor talks. Medical device risk classification sets the evidence, testing and fee profile that every commercial assumption depends on.
Table 2. Decision guide for medical device risk classification
| Situation | Risk if mishandled | Sensible next step |
|---|---|---|
| Foreign class is Class C or D | Local testing and evidence may be heavier than planned | Request a medical device risk classification review before budgeting |
| Product is an IVD for an infectious disease such as TB | Test scope can be far heavier than expected | Scope local testing early with a specialist |
| Product sits between two classes | Class challenged mid-review | Seek an expert classification opinion before filing |
| Class A assumed because the device seems simple | Intended use wording may raise the class | Review claims and intended use first |
High-risk devices are a special case. See our analysis of Indonesia’s Class 3/D requirements compared with global standards for more detail.
Regulatory Compliance for Medical Devices in Indonesia After Approval
Regulatory compliance for medical devices in Indonesia continues after approval. Permenkes No. 5/2026 also covers the control and supervision of health supplies, so registration holders remain accountable once products reach the market.
Business licensing for the health subsector follows the risk-based standards in Permenkes No. 11/2025 of the Ministry of Health, processed through the Online Single Submission (OSS) system. Distributors typically also need a medical device distribution licence (IDAK, Izin Distribusi Alat Kesehatan).
In our experience, compliance failures after approval often trace back to the original medical device risk classification, because labelling, distribution and vigilance duties were planned for the wrong risk level.
Five Common Mistakes in Medical Device Risk Classification
- Copying medical device risk classification from another country’s certificate without a local check.
- Choosing a lower class to reduce fees or testing, then facing re-evaluation.
- Scoping local testing only after the dossier is submitted.
- Writing intended use claims more broadly than the evidence supports.
- Ignoring regulatory change, including the replacement of Permenkes No. 62/2017.
Each mistake is avoidable when medical device risk classification is treated as a strategic decision, taken early and reviewed by a specialist.
Conclusion: Get Medical Device Risk Classification Right From the Start
Medical device risk classification shapes your Indonesian market entry, from testing scope to cost and timeline. The good news is that it is controllable: with early expert review, most surprises surface before they become expensive.
Product Registration Indonesia (PRI) helps manufacturers and importers confirm medical device risk classification, scope local testing, and build a registration file that matches the risk level. We would be glad to review your device with you.
Ready to confirm your class before it costs you? Fill out the contact form below, and our regulatory team will reach out to map your classification and testing scope.
