Class A — Low Risk Devices
Class A is the lowest risk category in Indonesia's medical device classification system. These devices have a low potential to cause harm and are subject to the most streamlined regulatory pathway.
Examples of Class A Devices
- Adhesive bandages and wound dressings (non-medicated)
- Tongue depressors
- Non-sterile examination gloves
- Stethoscopes
- Hospital furniture (examination tables, patient beds)
- Non-powered wheelchairs
- Reading glasses frames
- Thermometers (non-electronic, non-invasive)
- Gauze and cotton wool
Registration Pathway
Class A devices may follow a simplified notification or registration process. Key features:
- Lighter documentation requirements compared to Class B–D
- Shorter review timeline (approximately 15–30 days for administrative and technical review, though timelines may vary depending on completeness of submission)
- ISO 13485 certification strongly recommended but requirements are less stringent
- Clinical evidence is generally not required unless specified by Kemenkes for particular device types
All Class A devices require a valid NIE (Notifikasi Izin Edar) before they can be distributed in Indonesia. While the "low risk" classification significantly reduces documentation burden and review timelines compared to higher classes, it does not eliminate the registration requirement or the mandatory appointment of a local authorised representative (LAR).
Documentation Requirements
| Document | Required for Class A? |
|---|---|
| Letter of Authorization (LoA) | Yes — apostilled, 5-year validity |
| Free Sale Certificate (CFS/FSC) | Yes |
| ISO 13485 certificate | Recommended |
| Device description & intended use | Yes |
| Labeling (BI + English) | Yes |
| Risk analysis summary | Basic |
| Clinical evidence | Generally not required |
Halal Labeling Deadline
Under Government Regulation 42/2024, Class A devices must comply with Halal labeling requirements by 17 October 2026. Manufacturers should begin assessing their supply chain and material provenance well in advance.
See Halal Labeling for full details.