Hyperbaric Chamber Rules in Taiwan: TFDA Class 2, Licences, Ad Approval and Clinic Law

[ Pressure gauge ] Reference imagery; final photography in production

Hyperbaric chambers are legal in Taiwan. A chamber sold for a medical purpose is a medical device under the Medical Devices Act, which the Ministry of Health and Welfare runs through the Taiwan Food and Drug Administration (TFDA). The classification rules list the hyperbaric chamber as item D.5470, a Class 2 (medium risk) device. It must be registered and licensed by the central authority before it is made or imported. Only registered medical device firms may make, sell, rent or advertise it, and each device ad needs advance approval. Clinics that advertise treatment fall under the Medical Care Act. This page covers each rule for hospital units and for home or wellness chambers. It uses English texts of three Acts and two sets of regulations on the Laws and Regulations Database of the Republic of China (Taiwan), TFDA pages, two Ministry of Health and Welfare releases, and a National Taiwan University Hospital page. Some sources are in Chinese, and we mark where a point is our translation. We do not say whether any treatment works.

Legal, and regulated as a medical device

We read the Medical Devices Act in English on the Laws and Regulations Database, announced on 15 January 2020. The Ministry of Justice runs the database. It says that if the English and Chinese versions differ, the Chinese version prevails, and it shows a data update of 22 October 2026. The Chinese page shows the same 2020 date and no later amendment. Article 83 says that once the Act took effect, its rules replaced the medical device provisions of the Pharmaceutical Affairs Act.

Article 3 defines a medical device as an instrument, machine, apparatus, material, software, in vitro reagent or related article whose design and use achieve one of three primary intended actions in or on the human body, by means other than pharmacological, immunological, metabolic or chemical ones:

• diagnosis, treatment, alleviation or direct prevention of human disease;
• modification or improvement of the structure and function of the human body;
• control of conception.

Article 2 names the Ministry of Health and Welfare as the central competent authority, with municipal and county or city governments below it. We found no rule in the Act that bans hyperbaric chambers or limits them to hospitals.

Where the hyperbaric chamber sits in the classes

The item list sits in the Regulations Governing the Classification of Medical Devices, last amended on 22 August 2023. Article 2 sorts devices into 16 categories by medical specialty. Anesthesiology devices are the fourth. Article 3 sets three classes: Class I low risk, Class II medium risk and Class III high risk. Article 7 says the Regulations took effect on 1 May 2021.

We read the English annex and the Chinese annex, both PDFs from the same database. The English annex lists:

• D.5470, Hyperbaric chamber (高壓氧艙), Class 2: "a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure." It does not include topical oxygen chambers for extremities.
• I.5650, Topical oxygen chamber for extremities, Class 3.

The number and wording match the US entry. The text of 21 CFR 868.5470 on the Cornell LII site files the hyperbaric chamber under anesthesiology devices, with the same definition, as Class II (performance standards). For how the US files and clears the same device, see FDA cleared vs FDA registered. Article 4 of the Regulations adds rules for edge cases. A device that fits two items takes the higher class. An accessory made for one device takes that device's class. Article 6 says a device that fits no item in the annex is Class III, unless a predicate device is already registered or listed in Taiwan.

A firm or a member of the public can ask the TFDA which class applies. The TFDA classification inquiry page, updated 16 May 2022, says the fee is NT$3,500 per application and asks for the maker's instructions for use and any US or EU classification data.

Registration and licences for makers and dealers

The Act splits the market into medical device firms. Article 10 defines a manufacturer as a business that makes, packages, labels, sterilizes or releases devices, or that designs them and sells them under its own name. Article 11 defines a dealer as a business that sells devices wholesale or retail, or imports, exports, rents or repairs them. The main duties:

• Article 13: only medical device firms may do this business. Each firm applies to its municipal or county or city authority and may start only after it gets a business permit.
• Article 15: makers, and dealers that import or repair, must employ qualified technicians for the device category.
• Article 22: a maker needs a quality management system and a manufacturing licence after a compliance inspection. The same applies to overseas makers whose devices are imported.
• Article 24: for devices the authority names, dealers that wholesale, import or export need a good distribution system and a distribution licence.
• Article 25: each device needs registration and market approval, and a medical device licence, before it is made or imported. Items the authority names may use listing instead.
• Article 27: a licence lasts up to five years and can be extended for up to five years at a time.
• Article 32: the smallest sale unit needs a Chinese label and Chinese instructions.

The Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration, amended on 27 November 2023, set out the paperwork. Article 6 points Class 2 and Class 3 applicants to two appendices of documents. Articles 7 and 8 set a formality review and then a substantial review. Listing, with an annual declaration each October, is described for Class 1 devices. The TFDA page on registration of Class 2 and 3 devices, updated 12 June 2024, says each application covers one product name, and that models that share a classification number, name, maker and intended use may go in one application. Our UAE rules page notes that Dubai lists TFDA approval as one of the foreign approvals it accepts.

Buying, renting and using a chamber

Article 17 says medical device firms shall not buy or rent devices that have not been registered and approved or listed, or that come from a business that is not a medical device firm. Article 14 lets a medical institution supply devices linked to its own services without a dealer permit. A clinic that sells or retails devices to patients as a business must still register as a medical device firm.

The Act reaches clinics in other ways. Article 19 can require medical institutions to keep records of where certain devices came from and where they went. Article 48 says medical device firms or medical institutions shall report serious adverse events caused by a device. Article 51 lets the authorities inspect medical device firms and medical institutions and test their devices. Under Article 55, a device suspected of not being registered can be sealed on site and sampled, and the authority may announce that its use must stop. In the English text we did not find an article that, like Korea's Article 26, bars any person from using an unregistered device. For the Korean rule, see chamber rules in South Korea.

When a wellness chamber counts as a medical device

In Taiwan, the primary intended action decides. A soft or mild chamber designed and sold to treat or prevent a disease, or to change a body function, fits the Article 3 definition. The classification annex does not set a minimum pressure or a gas for item D.5470. If a product is a medical device, Article 25 applies and it needs a licence before it is made or imported.

A product that is not a medical device has its own limit. Article 46 says labelling or promotion of therapeutic effect for non-medical devices is not allowed, unless another law provides otherwise. The TFDA keeps a list of products it has decided are not medical devices. The page was updated on 26 June 2024, and the PDF list is dated 7 November 2023. It warns readers not to judge by product name alone. We found no chamber, oxygen capsule or pressure room on it.

We found no TFDA ruling on mild chambers as a group. The closest official case we read is older and about a different product. A Ministry of Health and Welfare release of 19 November 2014 says a doctor ran health centres that used a hydrogen and oxygen machine of unproven medical efficacy on patients (our translation). It says the Hualien County health bureau fined the operator NT$50,000 under Article 84 of the Medical Care Act, and that unlicensed practice at such centres would be pursued under Article 28 of the Physicians Act. For the pressure and gas differences between the two kinds of chamber, see mild vs medical hyperbaric.

Advertising a chamber: Chapter V of the Act

Article 6 defines a medical device ad as publicizing a device's therapeutic effect to solicit and promote its sale. Interviews, news reports or promotions that imply a therapeutic effect for the same purpose count as ads. Chapter V then sets the rules:

• Article 40: only medical device firms may advertise medical devices.
• Article 41: before an ad runs, the licence holder or the firm that completed the listing must submit all its text, pictures or speech for approval. A firm in a municipality goes to the municipal authority; a firm in a county or city goes to the central authority. The approved content may not be changed while the approval runs.
• Article 42: mass media may not run a device ad that has not been approved or that differs from the approved version.
• Article 43: an approval lasts three years and can be extended for up to three years at a time.
• Article 44: if the instructions say the device is to be used by medical personnel, ads may run only in medical publications, media or events for medical personnel.
• Article 45: ads may not run in the name of others, use books or documents to warrant performance, take the form of interviews or news reports, or use other improper means.

Article 44 may matter for hospital units. Whether it applies to a given chamber depends on what its approved instructions say, and we did not read any.

Advertising a treatment: the Medical Care Act

A clinic that advertises hyperbaric sessions is advertising medical care. We read the Medical Care Act in English on the same database, amended on 28 June 2023. Article 9 defines an advertisement of medical treatment as advertising medical practices to solicit patients. Article 87 adds that ads that imply or suggest medical practices count. The main rules:

• Article 84: non-medical care institutions shall not advertise medical care.
• Article 85: ad content is limited to set items, such as the institution's name, licence number and address, the physician's name and qualifications, NHI contracts, and clinic hours. Internet information is not bound by this list, with exceptions.
• Article 86: ads may not use another person's name, the content of medical publications, interviews or news reports, or other improper means.

Article 103 sets fines of NT$50,000 to NT$250,000 for breach of Articles 85 and 86. False, exaggerated or distorted content can also bring a practice suspension of one month to one year, or loss of the practice licence. Article 104 sets the same fine range for a non-medical institution that advertises medical care.

Who may run a chamber session

Article 2 of the Medical Care Act says a medical care institution is one where physicians practise medicine. Article 12 splits them into hospitals, which have wards, clinics, which have only outpatient facilities, and other medical care institutions. Article 15 says an institution must be approved and registered by its local authority before it opens. Article 10 lists the medical personnel, including physicians, nurses, physical therapists and respiratory therapists.

We read the Physicians Act in English, amended on 22 June 2022. Article 8 says physicians may practise only after registering and getting a practice licence. Article 28 sets prison of six months to five years, and a possible fine of NT$300,000 to NT$1,500,000, for practising as a physician without a licence. It exempts nurses and other medical personnel who work under a physician in a medical organization. The Acts do not name hyperbaric therapy. We found no Ministry notice on whether a session in a wellness centre counts as medical practice. For how staffing works elsewhere, see hyperbaric clinic staffing and certification.

National Health Insurance and hospital units

The hyperbaric oxygen centre page of National Taiwan University Hospital, updated 1 October 2026, lists what it calls the hyperbaric indications approved by the National Health Insurance Administration (our translation). The list has eight groups:

• decompression sickness and air or gas embolism;
• carbon monoxide or cyanide poisoning and smoke inhalation;
• clostridial gas gangrene and anaerobic infections;
• necrotizing soft tissue infection and mixed infection;
• radiation tissue injury, including osteoradionecrosis and radiation cystitis or enteritis;
• refractory osteomyelitis;
• crush injury, compartment syndrome and other acute traumatic ischemia;
• acute second and third degree burns covering 15 to 90 percent of body surface.

The page notes that refractory osteomyelitis, limb crush injury with traumatic bleeding, and the burns item need prior review by the NHIA. A Ministry of Health and Welfare release of 25 December 2008 says the insurer revised and added hyperbaric oxygen payment items for 2009, based on treatment guidelines from a US undersea medicine society, to improve appropriate use (our translation). We did not read the current NHIA payment schedule, so we cannot give codes, points or session limits. For how US payers code the treatment, see hyperbaric insurance and CPT codes.

Penalties in the Act

Chapter VIII of the Medical Devices Act sets the penalties. Article 74 says local governments impose most of them. The ones most likely to matter for a chamber business:

Source: Medical Devices Act, English text on the Laws and Regulations Database of the Republic of China (Taiwan), Articles 62 to 74. Read 4 November 2026.

A TFDA news release of 2 February 2025 applies the same rule to everyday products such as masks and tampons. It says anyone without a dealer permit may not sell medical devices through any channel, with a fine of NT$30,000 to NT$1,000,000 (our translation).

Hospital unit and wellness chamber side by side

Sources: Medical Devices Act, Regulations Governing the Classification of Medical Devices and its annex, Medical Care Act and Physicians Act, English texts on the Laws and Regulations Database of the Republic of China (Taiwan); TFDA pages on classification and products not listed as medical devices; Ministry of Health and Welfare release of 19 November 2014; National Taiwan University Hospital hyperbaric centre page. All linked above, read 4 November 2026.

For the same question nearby, see chamber rules in Japan and chamber rules in Hong Kong. For the hazards behind the engineering rules, see hyperbaric chamber safety. For the Americas, see chamber rules in Mexico. For the chambers we track and what we can verify about each, see the scorecard.

What we have not verified

We read the laws in English. The database says the Chinese text prevails, and we compared only the hyperbaric chamber entry in the Chinese annex. We did not read the Enforcement Rules of the Act, the appendices to the licence regulations, or the TFDA announcements that name which items may use listing, so we cannot confirm every document a Class 2 chamber needs. We did not search the TFDA licence database, so we do not know how many chambers hold a licence or what intended uses were approved. We found no TFDA ruling on mild chambers or oxygen capsules, and no Ministry notice on sessions in wellness centres. We did not read the current NHIA payment schedule; the covered uses come from a hospital page and may not match it. We found no national count of chambers and no official standard on oxygen levels inside a chamber. We could not confirm how pressure vessel inspection under labour safety law, or rules on medical gases, apply to a chamber.