Useful Links
Indonesian Government Portals
| Resource | URL | Description |
|---|---|---|
| Regalkes Portal | regalkes.kemkes.go.id | Online medical device registration portal — NIE applications, renewals, change notifications |
| Kemenkes Official Website | www.kemkes.go.id | Ministry of Health; regulations, news, announcements |
| BPOM Official Website | www.pom.go.id | National Agency of Drug and Food Control; regulations, safety alerts, public notices |
| BPOM e-Registration | e-reg.pom.go.id | BPOM's online portal (for pharmaceutical products) |
| OSS — Online Single Submission | oss.go.id | Business licensing portal; IDAK applications, NIB registration |
| BPJPH — Halal | bpjph.halal.go.id | Halal Product Assurance Agency; Halal certification information |
ASEAN Resources
| Resource | URL | Description |
|---|---|---|
| ASEAN Secretariat — Medical Devices | asean.org | ASEAN Medical Device Directive and CSDT documents |
| ASEAN CSDT Template | Via ASEAN Secretariat | Current CSDT version for device submissions |
International Standards
| Standard | Body | Relevance |
|---|---|---|
| ISO 13485 | ISO | Quality management systems for medical devices |
| ISO 14971 | ISO | Risk management for medical devices |
| IEC 62304 | IEC | Software lifecycle for medical device software |
| IEC 60601 series | IEC | Electrical safety for active medical devices |
| ISO 10993 series | ISO | Biological evaluation of medical devices |
| IMDRF SaMD guidance | IMDRF | Software as a Medical Device definitions and frameworks |
RAPath Hub
For regulatory information on other jurisdictions in the RAPath network:
| Jurisdiction | Site |
|---|---|
| Australia (TGA) | rapath.github.io/au |
| EU (MDR/IVDR) | rapath.github.io/eu |
| Canada (Health Canada) | rapath.github.io/hc |
| Singapore (HSA) | rapath.github.io/sg |
| UK (MHRA) | rapath.github.io/uk |
| Malaysia (MDA) | rapath.github.io/my |
| Indonesia (Kemenkes/BPOM) | rapath.github.io/id |
GitHub Repository
This site is maintained as part of the RAPath open-source medical device regulatory reference project. Contribute, report issues, or suggest improvements:
caution
Links to government portals may change as Indonesian agencies update their digital infrastructure. If a link is broken, search for the portal name directly via a search engine.