Overview of Medical Gases Regulation in Hong Kong

Introduction to Medical Gases Regulation

Hong Kong has established a robust regulatory framework for medical gases to ensure patient safety and product quality in healthcare settings. The new regulatory control of medical gases, which will come into effect on 14 June 2026, represents a significant advancement in pharmaceutical oversight, bringing Hong Kong's standards in line with international best practices.

Scope and Definition of Regulating Medical Gases as Pharmaceutical Products

The regulatory framework specifically covers any gases or mixtures of gases contained in cylinders that fulfil the definition of pharmaceutical products as stipulated under Section 2 of the Pharmacy and Poisons Ordinance (Cap. 138). This may cover medical gases including oxygen, nitrogen, nitrous oxide, nitric oxide, carbon dioxide, helium, medical air and mixture of some of the above gases. The medical gas product covers the gas/gas mixtures and its primary packing including the container and the valve.

However, there are gases which would not be controlled as pharmaceutical products in Hong Kong, which include:

• Gases that do not achieve their mode of action by pharmacological, immunological or metabolic action in human beings or animals;
• Gases produced in situ at healthcare facilities, i.e. manufactured, mixed and handled in hospitals or day procedures centres for their patient’s own use;
• Bulk liquefied gases in tankers or vessels (e.g. Vacuum Insulated Evaporator)¹;
• Gases specified for non-medicinal purposes such as in laboratories (e.g. for calibration), oxygen mixtures for smoke-helmeted firemen, oxygen mixtures for divers during normal diving and ascent, etc.;
• Oxygen that is produced via generator or concentrator to be used at patient’s bedside;
• Gases that are used in pulmonary function tests to measure gas transfer in the lung; and
• The equipment attached later to the gas container at the time of use (e.g. pressure regulator and pipe network).

¹ Manufacture and supply of such gases are subject to the requirements of Good Manufacturing Practice (“GMP”) Guides issued by the Board.

Pharmaceutical Product Registration Requirements

If you are selling gases or gas mixtures in cylinders that fulfil the definition of pharmaceutical products, they must be registered with the Pharmacy and Poisons Board of Hong Kong (the "Board") before they can be legally sold or supplied in Hong Kong.

To get the registration approval from the Board, you need to prove that the medical gases satisfy the criteria of safety, efficacy and quality for registration as pharmaceutical products with the Board.

Compliance with Supplementary Legislation

The Pharmacy and Poisons Ordinance (Cap. 138) operates alongside several other relevant laws governing medical gases, which include but not limited to:

1. Dangerous Goods Ordinance (Cap. 295)
2. Boilers and Pressure Vessels Ordinance (Cap. 56)
3. Fire Services Ordinance (Cap. 95)
4. Occupational Safety and Health Ordinance (Cap. 509)

Conclusion and Future Outlook

Hong Kong is putting new regulatory framework in place to keep up with the rising need for medical gases, while also make sure they are safe and high quality. Starting from 14 June 2026, any medical gases that are considered as pharmaceutical products must be registered with the Board before they can be legally sold or supplied in Hong Kong.

In addition, anyone who manufactures, wholesale, import and export of pharmaceutical products must first get the relevant trader licences from the Board. This includes companies selling pharmaceutical products that contain poisons. This new regulatory framework also set clear standards for how these medical gases must be stored and transported to keep them safe and effective.

For detailed guidance and updates, stakeholders may refer to the established website of the Drug Office of the Department of Health
(https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/medical_gases_regulation.html) and the Pharmacy and Poisons Board of Hong Kong (https://www.ppbhk.org.hk/eng/regulation_of_medical_gases.html). Ongoing collaboration between regulators and the industry will be vital to ensure the smooth implementation of these regulatory measures, which are designed to safeguard patient health and safety.