Import for Research (Clinical Investigations)
Overview
Unregistered medical devices may be imported into Indonesia for the purpose of clinical investigation — clinical trials and studies conducted to generate safety and performance data, typically in support of a future NIE application. This pathway is strictly regulated.
Dual Authorisation Requirement
Clinical investigation imports require two separate approvals:
- BPOM authorisation — the National Agency of Drug and Food Control must approve the clinical trial protocol before the investigation commences
- Ethics committee clearance — approval from an accredited Indonesian ethics committee (Komite Etik Penelitian Kesehatan)
Both approvals must be in place before any device is imported for research purposes.
BPOM Clinical Trial Authorisation
Applications to BPOM for clinical trial authorisation must include:
| Document | Notes |
|---|---|
| Clinical trial protocol | Full protocol describing design, objectives, endpoints, statistical plan |
| Investigator's Brochure | Complete device and preclinical data package |
| Case Report Forms | Draft CRFs for data collection |
| Patient informed consent form | Draft consent document in Bahasa Indonesia |
| Summary of available safety data | Device description, preclinical data, any prior clinical use data |
| Product quality documentation | Certificate of Analysis, GMP certificate |
| Ethics committee application (simultaneous) | BPOM and ethics committee review typically run in parallel |
Ethics Committee Approval
Ethics committees (Komite Etik Penelitian Kesehatan) are independent bodies accredited by the National Health Research Ethics Commission (KNEPK) that review research protocols for:
- Ethical integrity (informed consent, participant protection, risk–benefit balance)
- Scientific validity
- Researcher qualifications and facility capability
- Compliance with applicable GCP guidelines
Ethics committee review typically runs in parallel with BPOM review. Both approvals are required before import.
Good Clinical Practice (GCP)
Clinical investigations must comply with GCP guidelines as recognised by BPOM. Indonesia aligns with ICH E6 GCP principles. Key requirements:
- Qualified principal investigator at an approved clinical research site
- Independent monitoring
- Adverse device effect reporting during the trial
- Data integrity and audit trail
- Regulatory authority inspection readiness
SKI — Per-Shipment Import Permit
Even with BPOM and ethics committee approval, each shipment of investigational devices into Indonesia requires a separate SKI (Surat Keterangan Impor — Import Certificate) from Kemenkes. The SKI is tied to the specific shipment, lot numbers, and quantities. Plan for this administrative step in your clinical supply chain timeline.