Regulation of Medical Gases: An Overview

In June 2024, the Pharmacy and Poisons Board of Hong Kong (the Board) has endorsed to regulate medical gases as pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138) (the Ordinance). In addition, pharmaceutical products containing nitrous oxide and nitric oxide will be regulated as prescription drugs. The new regulatory control will come into effect on 14 June 2026.

The scope of the regulatory control of medical gases covers any gases or mixtures of gases in cylinder that fulfil the definition of pharmaceutical products as stipulated under section 2 of the Ordinance, which may cover medical gases including oxygen, nitrogen, nitrous oxide, nitric oxide, carbon dioxide, helium, medical air and mixture of some of the above gases, except:

1. Gases that do not achieve their mode of action by pharmacological, immunological or metabolic action in human beings or animals;
2. Gases that are produced in situ in healthcare facilities, i.e. manufactured, mixed and handled in hospitals or day procedure centres for their patients’ own use;
3. Bulk liquefied gases in tankers or vessels (e.g. Vacuum Insulated Evaporator) (Note: Manufacture and supply of such gases are subject to the requirements of Good Manufacturing Practice (“GMP”) Guides issued by the Board. Please refer to the website of the Board (www.ppbhk.org.hk) for the current version of the GMP Guides);
4. The equipment attached later to the gas container at the time of use (e.g. pressure regulator and pipe network);
5. Gases specified for non-medicinal use such as in laboratories (e.g. for calibration), oxygen mixtures for smoke-helmeted firemen, oxygen mixtures for divers during normal diving and ascent, etc.;
6. Oxygen that is produced via generator or concentrator to be used at patient’s bedside; and
7. Gases that are used in pulmonary function tests to measure gas transfer in the lung.

When the new regulatory control takes effect, the pharmaceutical products of medical gases have to be registered with the Board before they can be legally sold or supplied in Hong Kong. In addition, traders of the pharmaceutical products must obtain relevant licence(s) from the Board before conducting manufacture and wholesale (including import and export) of pharmaceutical products, and retail sale of pharmaceutical products containing poisons.

For more information on the registration of pharmaceutical products and licensing of traders, please visit the website of the DH’s Drug Office (https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html).

Medical gases or mixture of gases are also regulated under other legislations in Hong Kong. The regulation of medical gases under the Ordinance does not exempt the traders from complying with other legislations. Traders should observe and follow all the relevant statutory requirements stipulated under the related ordinances, which include but are not limited to:

1. Boilers and Pressure Vessels Ordinance (Cap. 56)
2. Factories and Industrial Undertakings Ordinance (Cap 59)
3. Fire Services Ordinance (Cap. 95)
4. Dangerous Goods Ordinance (Cap. 295)
5. Electricity Ordinance (Cap. 406)
6. Occupational Safety and Health Ordinance (Cap.509)