Think Your Clinical Data Is Sufficient? Why Indonesian Regulators Demand More

You’ve invested millions in clinical trials across Europe or the U.S.—surely that should be enough to prove your medical device works, right?

Not quite. In Indonesia, the Ministry of Health (Kemenkes) expects product performance to be validated locally, reflecting unique environmental and patient‐population factors.

Tropical Climate and Local Patient Profiles Matter

Indonesia’s hot and humid conditions can affect device performance, durability, and sterility in ways not captured by studies conducted in temperate regions. Under Kemenkes Regulation No. 62 of 2017 (on medical device evaluation), any device seeking registration must demonstrate that it remains safe and effective under local storage and usage conditions, including temperature and humidity extremes (repository.kemkes.go.id). Moreover, demographic differences—such as variations in average body mass index, prevalence of comorbidities, and genetic factors—can influence how a device behaves in routine clinical practice. As a result, Kemenkes requires either:

• Bridging Studies (Uji Klinik Lokal): These verify that overseas clinical data remain applicable to Indonesian patients (e.g., verifying imaging accuracy in local radiology centers).Stability and Performance Tests: Performed at ISO/IEC 17025–accredited laboratories in Indonesia to ensure devices maintain functionality under tropical conditions (repository.kemkes.go.id).

Even if your device excelled in U.S. or European trials, Indonesian regulators want concrete proof it performs just as well here.

Expert Panel Reviews (Tim Ahli) Go Deeper

For higher‐risk medical devices (Class C or D, as defined by Kemenkes Decree No. HK.01.07/Menkes/4745/2021), your registration dossier won’t just be screened by administrative staff. It goes before an expert panel of academics, clinicians, and government representatives, per the “Pedoman Teknis Evaluasi Alat Kesehatan” (repository.kemkes.go.id). These panels ask questions that your foreign Institutional Review Board (IRB) may never have considered, such as:

• How does your device perform among typical Indonesian patient subgroups (e.g., different ethnicities or comorbidity profiles)?Are there local safety concerns—such as device malfunctions under high humidity or limited access to specialized service centers?Has sufficient local-biocompatibility testing been done to account for dietary and environmental exposures common in Indonesia?

Preparing for this scrutiny means anticipating these local perspectives early in your clinical‐planning phase.

Ongoing Post-Market Surveillance (PMS) Is Non-Negotiable

Approval is only step one. Kemenkes mandates continuous post-market safety monitoring for all registered medical devices under “Panduan Pengawasan Alkes Non-Elektromedik” (2019) (repository.kemkes.go.id). You must:

• Maintain an Incident Registry: Document and report any adverse events (e.g., malfunction, injury, or infection) within the specified timelines.Provide Annual Safety Reports: Summarize real-world device performance, including any device recalls, corrective actions, or field safety notices.Engage in Periodic Field Inspections: Ensure your distribution channels and service centers remain compliant with Kemenkes standards for device maintenance and calibration.

Failure to provide timely, locally sourced post-market data can lead to delayed renewals, refusal of future product approvals, or even revocation of existing licenses.

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Treat your foreign clinical data as a foundation rather than the finish line. Indonesian regulators expect locally generated evidence to ensure medical devices are truly safe and effective for their market.

Planning ahead for bridging studies, tropical‐condition testing, and ongoing post-market compliance will save you time, money, and headaches—ultimately accelerating patient access to innovative medical devices in Indonesia’s fast-growing healthcare sector.

At INSIGHTOF, we specialize in navigating these local requirements with ease. From bridging study design to full post-market surveillance support, our regulatory experts ensure your device meets Kemenkes standards from Day 1.

Do you need assistance registering your product in Indonesia?
Contact us today to start your registration process.

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References:

1. Kementerian Kesehatan Republik Indonesia. Guidelines for Evaluation of Medical Devices and In Vitro Diagnostic Medical Devices (Reg. No. 62/2017). Direktorat Jenderal Kefarmasian dan Alat Kesehatan. 2020. (repository.kemkes.go.id)
2. Kementerian Kesehatan Republik Indonesia. Panduan Teknis Pengawasan Alat Kesehatan Non Elektromedik Steril dan Alat Kesehatan Diagnostik In Vitro di Sarana Distribusi Alat Kesehatan. 2019. (repository.kemkes.go.id)