Hyperbaric Chamber Rules in Indonesia: Izin Edar Permits, Class C Listings, Device Ads and Clinic Ads

[ Pressure gauge ] Reference imagery; final photography in production

Hyperbaric chambers are legal in Indonesia. A chamber sold for a medical purpose is an alat kesehatan, a medical device, and it needs a distribution permit, the izin edar, from the Ministry of Health before it can be sold. The rules sit in Minister of Health Regulation (Permenkes) No. 62 of 2017, which sorts devices into four risk classes, A to D. No regulation we read names the chamber's class. The ministry's public register does: every record with the product type hyperbaric chamber is Class C, filed under therapeutic anaesthesia equipment. Device ads must follow Permenkes 76 of 2013, and ads for clinics and hospitals follow Permenkes 1787 of 2010. This page covers each rule for hospital units and for home or wellness chambers. It uses the regulations as published by the ministry's legal database, the 2023 Health Law, ministry guidance and the ministry's device register. All sources are in Indonesian unless noted, and the translations are ours. We do not say whether any treatment works, and we do not name or rate any clinic or brand.

Legal, with an izin edar

The ministry's legal database hosts Permenkes 62 of 2017, on distribution permits for medical devices, in vitro diagnostic devices and household health products. It was signed on 29 December 2017 and took effect when published on 12 January 2018. Its preamble says the older 2010 rule had to be brought into line with ASEAN and global harmonisation.

Article 1 defines a medical device as an instrument, apparatus, machine or implant, without a drug, used to prevent, diagnose, cure or ease disease, care for the sick, restore health, or shape structure and improve body function (our translation). A clinical hyperbaric chamber fits that wording. Article 4 says every device made, imported, assembled or repacked for sale in Indonesia must have an izin edar. Article 5 exempts devices brought in through the Special Access Scheme, some devices made by household businesses, and devices the Minister exempts for particular reasons.

The Health Law, No. 17 of 2023, enacted on 8 August 2023, sits above the regulation. Article 138(3) bars anyone from making, storing, promoting or selling a device that does not meet safety, benefit and quality standards. Article 143 says anyone who makes or sells devices needs a business licence from the central or regional government. We found no rule that bans hyperbaric chambers or limits them to hospitals.

Who regulates: the Ministry of Health

Article 4 of Permenkes 62 says the Minister of Health grants the izin edar and delegates it to the Director General, in practice the Directorate General of Pharmaceuticals and Medical Devices. Under Article 18, new applications go online through the Indonesia National Single Window or the regalkes.kemkes.go.id site. The permit is issued in electronic form, without a wet signature or stamp. The ministry's infoalkes register lets anyone search permits by number, product name, applicant, type, maker or product type. The register files permits under two headings, domestic (AKD) and imported (AKL).

Classes A to D

Article 7(1) sorts devices by the risk their use poses to the patient (our translation):

• Class A: low risk.
• Class B: low to moderate risk.
• Class C: moderate to high risk.
• Class D: high risk.

Article 7(4) leaves the detailed rules to a Director General regulation, which we did not find. Annex I lists categories and subcategories, from clinical chemistry to general and plastic surgery. Category D is anaesthesia equipment, and its subcategories include therapeutic anaesthesia equipment. A ministry slide deck, Klasifikasi Alat Kesehatan, says the four classes follow the ASEAN Medical Device Directive. It also says the applicant must decide the class on its own, and suggests matching the product type to the US Code of Federal Regulations. The 2020 evaluation guideline, covered below, says that if the chosen class is lower than it should be, the file goes back to the applicant to pay the higher fee. For other ASEAN members, see chamber rules in Malaysia, chamber rules in Singapore, chamber rules in Thailand and chamber rules in the Philippines.

Where a hyperbaric chamber sits

We searched the text of Permenkes 62 for hiperbarik and hyperbaric and found neither. So the regulation does not name the chamber's class. The register is the best evidence. Every record with the product type hyperbaric chamber shows Class C and the subcategory therapeutic anaesthesia equipment (Peralatan Anestesi Terapetik).

The US code the slide deck points to puts the device in the same family. 21 CFR 868.5470 sits in Part 868, Anesthesiology Devices. It defines a hyperbaric chamber as a device intended to increase the environmental oxygen pressure by pressurization greater than atmospheric pressure, and places it in Class II. US and Indonesian classes do not map one to one. For how the US files the device, see FDA cleared vs FDA registered.

A soft or mild chamber sold for wellness raises a separate question. If the seller claims no medical purpose, the definition in Article 1 may not reach it. We found no ministry ruling on soft chambers. Three register records for the hyperbaric chamber product type are marked non-electromedical, but they still show Class C. For the pressure and gas differences, see mild vs medical hyperbaric.

What the public register shows

We searched the infoalkes register by product type for hyperbaric on 6 November 2026. It returned 113 records, all with the product type hyperbaric chamber. Of these, 82 are domestic (AKD) and 31 are imported (AKL). Forty were marked valid: 35 domestic and 5 imported. The rest were marked not valid. The valid permits were issued between 2022 and 2026. The imported records list makers in ten countries, led by Turkey. A permit in the register is not a finding that a chamber works, and we do not list brands here.

Getting an izin edar

Under Article 10, the permit for an imported device is applied for by a sole agent or exclusive distributor, or by a distributor (PAK) that holds a letter of appointment from the maker. Article 13 allows one agent per brand of each device type. Article 14 requires a certificate of free sale from the health authority in the country of manufacture. Article 19 says devices with new technology or unusual claims go to an expert team.

Article 20 sets review times by class. For an imported Class C device, review takes up to 30 days, against 20 days for a domestic one. If the file is complete, the permit follows within 10 days. Article 24 says a permit lasts up to five years, and for an agent it follows the term of the appointment letter, which must run two to five years. The ministry's 2020 evaluation guideline, in Indonesian and English, lists a fee of Rp 3,000,000 for a new Class B or C application. It also asks products that run on mains power or batteries for an IEC 60601 electrical safety certificate and test results from an accredited laboratory or notified body.

Importers, labels and used chambers

Article 44 says only a company with a PAK licence and an izin edar for the device may import it. Article 46 lets the Director General issue a special import letter for patient care, service improvement or research. Article 48 bars importing, using or selling any device that is not new, including reconditioned or remanufactured devices. On our reading, that covers a used chamber. For checks on a used unit elsewhere, see the used chamber inspection checklist.

Article 41 sets the label. It must show the brand, the izin edar number, the type, the maker and the permit holder, the serial number, specifications, intended use and instructions. Devices that must be run by trained staff carry the warning "Hanya Boleh Digunakan oleh Tenaga Profesional" (only to be used by professionals) or a white P on a black background. Intended use, instructions, contraindications and warnings must be in Indonesian. Labels must not use words such as paling (most), ampuh (potent), mengobati (treats), anti-aging or relaksasi.

Advertising a chamber

Permenkes 76 of 2013 covers device ads. It was signed on 6 December 2013 and published on 10 February 2014. Article 4 says only a device with an izin edar may be advertised. Article 2(2) says a device that needs a trained professional to use it may be advertised only in medical and pharmacy journals and at professional forums. Article 5 requires prior approval for household health product ads; we found no such step for device ads. Article 8 bars device ads that:

• claim or suggest the device can cure a disorder or disease;
• suggest it can prevent, slow or reverse changes linked to ageing;
• claim it is perfect or guarantees a cure;
• set aside main treatment, or give advice or diagnosis for serious and chronic disease.

Article 7 also bars testimonials, claims that the device prevents disease, and research data that cannot be checked. Article 9 bars showing health workers, or actors dressed as them, except in health magazines, public service ads and professional forums. Under Article 16, the ministry can order an ad changed or pulled within seven working days. If the maker does not comply, it can issue a written warning or revoke the izin edar.

Advertising a clinic or hospital

A facility that offers sessions falls under Permenkes 1787 of 2010, on ads and publicity for health services. The copy we read is a scan. Article 4 says facility ads must be accurate, evidence based, informative, educational and responsible, and must give the facility's name and address and the date in print, broadcast and outdoor media. Article 5 bars ads that, among other things:

• give false or misleading information;
• praise the facility with superlatives or claims to be the only one;
• promote new or unconventional methods, drugs or devices whose benefit and safety are still in doubt or unproven;
• advertise devices without an izin edar;
• offer discounts or other sales promotions;
• use testimonials in mass media.

Article 8 bars health workers from advertising, or modelling for ads for, devices and health facilities, except in public service ads.

Facility licences and the service standard

Article 165(5) of the Health Law says every health facility must hold a business licence from the central or regional government. Article 108 makes sea health (kesehatan matra laut) a special form of health effort. The elucidation defines it as health linked to work at sea in high pressure (hiperbarik) settings, such as diving, and the services must follow standards and requirements set by later rules.

We found no current national rule on who may run a chamber session or how a wellness centre with a chamber is licensed. A 2021 article in the Jurnal Hukum dan Etika Kesehatan cites Minister of Health Decree No. 120/MENKES/SK/II/2008 as the hyperbaric medical service standard, and says hospital directors use it as their reference. We could not obtain the decree. The ministry library lists a 2012 ministry book on occupational disease from hyperbaric exposure and diving. For the fire and oxygen hazards that drive chamber design, see hyperbaric chamber safety.

Navy and hospital units

A Ministry of Defence page from May 2016 reports a training course on technical standards and fitness for use of high pressure air rooms (ruang udara bertekanan tinggi, or RUBT), held at the Mintohardjo naval hospital in Jakarta from 25 to 27 May 2016. It says the aim was to meet chamber standards under PVHO (Pressure Vessels for Human Occupancy) and/or ASME, and to agree on a hyperbaric standard for operators and users across Indonesia. The hospital has a RUBT subdepartment. We found no public national list of hospital units, and no rules on public insurance coverage.

Penalties

Article 435 of the Health Law sets up to 12 years in prison or a fine of up to Rp 5 billion for making or selling a device that does not meet the safety, benefit and quality standards in Article 138(3). Article 63 of Permenkes 62 sets administrative sanctions: a written warning, a temporary halt, or revocation of the izin edar. Article 64 says selling a device without an izin edar, or breaches that cause serious harm, disability or death, can lead to criminal sanctions under other laws.

Hospital unit and wellness chamber side by side

Sources: Permenkes 62 of 2017, Permenkes 76 of 2013, Permenkes 1787 of 2010 and Health Law No. 17 of 2023, all from the Ministry of Health legal database; ministry classification slides and 2020 evaluation guideline; infoalkes register search; 21 CFR 868.5470; Ministry of Defence news page, 2016; Jurnal Hukum dan Etika Kesehatan, 2021. All linked above, read 6 November 2026.

For the chambers we track and what we can verify about each, see the scorecard.

What we have not verified

No regulation we read names the chamber's class, so Class C rests on the register, not on a rule. We did not find the Director General regulation on classification. We did not check whether later rules changed the review times in Article 20 or the fee in the 2020 guideline. The register search returns records as the ministry stores them, and we did not open each permit. We could not read Decree 120 of 2008, so we cannot say whether it is still in force or what it requires. We found no ruling on soft chambers, on wellness sessions, or on whether a wellness centre that runs a chamber counts as a health facility. We did not check rules on pressure vessels or medical oxygen, and we did not read the ASEAN directive. We found no national count of hospital units and no public insurance coverage rules.