Medicinal Gases

Directive & Guideline for Registration of Medicinal Gases Good Manufacturing Practice (GMP) Inspection on Medicinal Gases Manufacturers Medicinal Gas: Frequently Asked Question (FAQs)

REGULATORY CONTROL OF MEDICINAL GASES

1. Introduction:

1.1 Medicinal gases are gases or gas mixtures intended for the administration to patients for medicinal purpose such as anaesthetic, therapeutic, prophylactic and diagnostic use.

1.2 Based on Drug Registration Guidance Document (DRGD); Appendix 2 Table I: Medical Device-Drug-Cosmetic Interphase (MDDCI) and Combination Products Classification Decision, medicinal gases are classified into two (2) categories as below:

a) Medicinal gases classified as a medicinal product / drug (regulated by Drug Control Authority (DCA)):

Gases or gas mixtures which mode of action is achieved primarily based on pharmacological, immunological or metabolic action in/on the body.

b) Medicinal gases classified as medical device (regulated by Medical Device Authority (MDA)):

Gases or gas mixtures which mode of action is achieved primarily by physical in nature and not achieved primarily based on pharmacological, immunological or metabolic action in/on the body.

1.3 Medicinal gases classified as a medicinal product / drug (regulated by Drug Control Authority (DCA)) covers medicinal gas in cylinders intended for inhalation, which manufactured in a filling plant from bulk liquid gas for the following six (6) types of medicinal gases:

Oxygen, O₂ (not less than 99%v/v oxygen)
Carbon dioxide, CO₂ (not less than 99%v/v carbon dioxide)
Nitrous oxide, N₂O (not less than 98%v/v nitrous oxide)
*Nitric oxide, NO (not less than 99%v/v nitric oxide)
Nitrous oxide/oxygen mixture (50:50%)
Medical air (oxygen/nitrogen mixture; 19.5 - 23.5%v/v of oxygen (O₂))

*Nitric oxide, NO (Group B Scheduled Poison)

2. Implementation:

The medicinal gas industries should abide with the following implementation dates for medicinal gas products classified as medicinal product / drug:

Good Manufacturing Practice (GMP) Inspection: starting 1st June 2021

Licensing and product registration (voluntary): starting 1st January 2022

Licensing and product registration (mandatory): starting 1st January 2023

For details on registration requirements, please refer to the links below:

1) Directive & Guideline for Registration of Medicinal Gases
2) Guidance Note: Good Manufacturing Practice (GMP) Inspection on Medicinal Gases Manufacturers
3) Medicinal Gas: Frequently Asked Question (FAQs)

Last updated on 25 June 2024