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 (~15–30 days for administrative and technical review)
- ISO 13485 certification strongly recommended but requirements are less stringent
- Clinical evidence is generally not required unless specified by Kemenkes for particular device types
Even Class A devices require a valid NIE before they can be distributed in Indonesia. The "low risk" classification reduces documentation burden but does not eliminate the registration requirement or the need for 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.