Device Classification System
Overview
Indonesia classifies medical devices into four risk classes — A through D — using a risk-based system aligned with the Global Harmonization Task Force (GHTF) and the ASEAN Medical Device Directive (AMDD). The class a device falls into determines the documentation requirements, regulatory pathway, and review timeline for obtaining the NIE (Nomor Izin Edar).
The Four Classes
| Class | Risk Level | Examples | Pathway |
|---|---|---|---|
| A | Low | Adhesive bandages, tongue depressors, non-sterile examination gloves | Notification / simplified registration |
| B | Low to moderate | Hypodermic needles, infusion sets, sterile surgical gloves | Standard registration |
| C | Moderate to high | Ventilators, surgical lasers, powered wheelchairs, haemodialysis equipment | Full registration with clinical evidence |
| D | High | Active implantables, cardiac stents, implantable defibrillators | Full registration, clinical data, maximum scrutiny |
Classification Criteria
Classification is based on a combination of factors drawn from GHTF/ASEAN principles:
1. Invasiveness
- Non-invasive — devices that do not contact the patient's body internally
- Invasive — body orifice — devices that enter via a natural body orifice (e.g. mouth, ear, nostril)
- Surgically invasive — devices that penetrate through a surgical incision
- Implantable — devices intended to remain in the body long-term
2. Duration of Contact
- Transient — less than 60 minutes
- Short-term — 60 minutes to 30 days
- Long-term — more than 30 days
3. Active vs Passive
- Active devices — rely on an energy source (electrical, thermal, radiation) to achieve their function
- Passive devices — do not rely on a power source
4. Specific Rules
Certain device types have dedicated classification rules regardless of the general criteria, including:
- Devices containing medicinal substances
- Devices used with or in contact with the central nervous system or cardiovascular system
- Devices for contraception or prevention of sexually transmitted infections
- IVD devices (governed by a separate set of IVD classification rules)
Classification Process
There is no formal pre-classification application process in Indonesia similar to, for example, an FDA 513(g) request. Classification is:
- Determined by the manufacturer based on the GHTF/ASEAN classification rules
- Declared in the registration dossier submitted through Regalkes
- Reviewed and confirmed by Kemenkes evaluators during the technical review phase
If you are unsure of your device's classification, the ASEAN AMDD classification rules document (available via the ASEAN Secretariat) provides detailed worked examples. You can also reference equivalent device classifications from your existing approvals in Singapore (HSA), Malaysia (MDA), or the ASEAN AMDD annex.
Key Classification Implications
| Class | ISO 13485 Required? | Clinical Evidence | Review Timeline | Halal Deadline |
|---|---|---|---|---|
| A | Recommended | Generally not required | ~15–30 days | Oct 2026 |
| B | Yes (for imports) | Literature review | 3–6 months | Oct 2029 |
| C | Yes | Clinical evaluation report | 6–12 months | Oct 2034 |
| D | Yes | Full clinical data, possibly local trial | 6–12+ months | ~2039 |
IVD Classification
In-vitro diagnostic devices (IVDs) follow a separate classification framework based on the nature of the specimen, the intended use, and the public health risk. See IVD Classification for full details.
GHTF Classification Reference
The GHTF SG1 Study Group documents, particularly GHTF/SG1/N77:2012 — Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers and GHTF/SG1/N71:2012 — Summary Technical Documentation (STED), are key references for understanding how Indonesia's framework maps to international norms.