What Is a Medical Device?
Under Indonesian law, a medical device (alat kesehatan) is any instrument, apparatus, machine, implant, in-vitro reagent, calibrator, software, material, or other article — whether used alone or in combination — that meets all of the following criteria:
-
Intended by the manufacturer to be used for human beings for one or more of the following purposes:
- Diagnosis, prevention, monitoring, treatment, or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or disability
- Investigation, replacement, modification, or support of anatomy or a physiological process
- Supporting or sustaining life
- Control of conception
- Disinfection of medical devices
- Providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body
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Does not achieve its principal intended action by pharmacological, immunological, or metabolic means — though it may be assisted by such means.
Scope of the Definition
The Indonesian definition aligns closely with the ASEAN Medical Device Directive (AMDD) and the Global Harmonization Task Force (GHTF) framework. It covers:
- Diagnostic and therapeutic equipment (imaging systems, surgical instruments, ventilators)
- Implantable devices (stents, orthopaedic implants, pacemakers)
- In-vitro diagnostic (IVD) devices and reagents
- Software that qualifies as a medical device
- Consumables and single-use items (gloves, syringes, bandages)
- Personal protective equipment used in medical settings
- Household health products (Perbekalan Kesehatan Rumah Tangga, PKRT) — regulated separately under specific provisions
What Is NOT a Medical Device?
The following are explicitly not classified as medical devices under Indonesian regulation:
| Product Type | Regulatory Pathway |
|---|---|
| Pharmaceutical drugs | BPOM registration |
| Traditional herbal medicines (jamu) | BPOM registration |
| Cosmetics | BPOM notification |
| Food and health supplements | BPOM registration |
| Pesticides and disinfectants for non-medical use | Ministry of Agriculture / Ministry of Environment |
| Industrial machinery | Ministry of Industry |
A device that incorporates a pharmaceutical substance as an integral part (e.g. a drug-eluting stent) is generally still classified as a medical device in Indonesia, but may require consultation with both Kemenkes and BPOM during registration.
Household Health Products (PKRT)
Indonesia has a specific category for Household Health Products (Perbekalan Kesehatan Rumah Tangga — PKRT), which covers items such as:
- Household disinfectants
- Insect repellents used for health protection
- Contraceptives (non-device)
- Some personal hygiene products
PKRT products are regulated under a separate notification/registration process within Kemenkes but may follow a lighter-touch pathway compared to medical devices.
Key Reference
The primary legal definition is found in:
- Minister of Health Regulation (Permenkes) No. 62 of 2017 — Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro, dan Perbekalan Kesehatan Rumah Tangga
See also the Key Legislation page for a full list of applicable regulations.