Are medical gases subject to regulation?

Are medical gases subject to regulation?

In this content we will discuss about medicinal gases. Do you know if this product needs some kind of regularization with the National Health Surveillance Agency?

To clarify this issue, we will address the topics related below:

  • What are medical gases?
  • What is the difference between medical gases and other gases, such as industrial ones?
  • Are companies that manufacture medical gases regulated by ANVISA?
  • Are medicinal gases regulated by ANVISA?
  • Manufacturing companies must follow Good Manufacturing Practices
  • Must medicinal gases have a package insert?
  • Clear your doubts.

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What are medical gases?

A medical gas is a gas or mixture of gases intended for the treatment or prevention of disease in humans or administered to humans for medical diagnosis or to restore, correct or modify physiological functions.

They are used in hospitals, health clinics or other places of interest to health, as well as in home treatment of patients.

Some examples of medical gases: medical oxygen, medical synthetic air, medical nitrous oxide, and medical carbon dioxide.

What is the difference between medical gases and other gases, such as industrial ones?

Medicinal gases must follow purity and quality standards established in the Brazilian Pharmacopoeia or other international compendiums. In addition, they need to be produced by organizations that have a license and authorization from the competent health authorities and that adhere to Good Practices for the Manufacture of Medicinal Gases, in accordance with ANVISA standards.

INMETRO establishes specific cylinder color schemes for each gas and its destination in order to more effectively distinguish between industrial and medical gases. Oxygen, for example, has industrial and medical applications. When for medicinal use it must be injected in green balloons, while for industrial use it must be injected in black cylinders.

Do companies that manufacture medicinal gases need to be regulated by ANVISA?

Yes, all companies involved in the production stages of medicinal gases, such as chemical sintering, gas compression or separation and the use of any type of packaging, are governed by ANVISA.

That is, companies that manufacture and bottle medical gases must apply for a health license from the local health authority and operating permits (AFE), in addition to complying with other health standards.

In addition, even if the Notification or Registration of Medicinal Gases is suspended, all businesses that manufacture or package these gases must comply with the requirements of Good Manufacturing Practices as described in RDC No. 301/2019 and IN No. 38/2019.

Must Medicinal Gases present a package insert?

Currently, the addition of a package insert to medical gas cylinders is optional, but encouraged, however the indications, contraindications, precautions and adverse reactions of medical gases of mandatory notification are not listed in Annex II of RDC nº 70/2008.

In need of advice or consultancy to adapt to current medical gas regulations? Talk to Stone Okamont, we have expertise in regularizing your establishment and product.

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