Regulatory Insights for Device Manufacturers
During the COVID-19 Pandemic
Clinical and Regulatory Manager, Hydrix
The global COVID-19 pandemic has seen exponential growth in the demand for personal protective equipment (PPE) such as face masks, gloves, protective coveralls and protective eyewear, as well as for medical devices such as ventilators and other primary clinical treatment devices. In parallel with this increased demand, the global supply chain of such products has sustained significant disruptions due to factors such as forced quarantine resulting in a lack of labor and raw materials or even market forces disrupting established supply chains.
The repercussions of these disruptions are impacting the medical community as it struggles to contain the virus and avoid its further spread.
Device regulation and assessment is a critical step in the supply chain and major medical device regulators around the world have been fast to introduce expedited pathways for PPE and medical devices. The aim is to ensure this equipment will be available for the medical community to combat COVID-19 . It is important for manufacturers to understand these revisions to the regulations and import/export requirements for the major markets for PPE.
Our review of the current status of regulations confirms that:
Australian manufacturers can export locally produced PPE and medical devices to the United States and European markets
Regulators in the United States, European, and Australian markets have introduced expedited regulatory pathways for the manufacture and registration of PPE and medical devices to combat the COVID-19 pandemic.
Regulators have provided clear definitions and criteria for products to be considered under an emergency use authorization.
Each region’s regulators have introduced their own specific expedited regulatory pathways and we have captured these for clarity.
Regulation within Australia
In response to COVID-19, the Australian Therapeutic Goods Administration has issued guidance on the regulation of PPE and other medical devices. Under the Therapeutic Goods (Declared Goods) Order 2019 non-sterile protective and safety apparel or equipment are not considered to be therapeutic goods when used:
a. In the home; or
b. For occupational or recreational use.
This means that non-sterile PPE including masks, gowns and gloves that do not make any therapeutic claims are regulated as general consumer items and do not need to be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied.
All other PPE, including masks, gowns and gloves that are presented or claim to be for therapeutic use, such as surgical or examination masks intended to reduce or prevent the transmission of COVID-19, meet the definition of a medical device, and are regulated. The pathway for supply of PPE and other medical devices in Australia is described here:
Regulations for supply of PPE to Europe
In response to COVID-19, the Commission of European Communities has provided recommendation (EU) 2020/403 of 13th March 2020 on conformity assessment and market surveillance procedures.
This recommendation enables faster approval of PPE and medical devices to help combat and prevent the further spread of the disease.
United States Food and Drug Administration (FDA)
Many Australian manufacturers are asking “How can I get my products to into the US market and do they require FDA review?” The following describes the pathway under the U.S. FDA - Emergency Use Authorisations (EUAs).
In response to the Department of Health and Human Services (HHS) declaration of the COVID-19 pandemic, the U.S. FDA has utilised EUAs to help make medical products available as quickly as possible, by allowing unapproved medical products to reach patients in need when there are no adequate FDA-approved, and available alternatives.
Examples of these products include:
Advanced Sterilisation Products (ASP)
Blood Filter Device or Purification Systems
Diaphragm Pacing Therapy System (DPTS)
N95 or N95-equivalent respirators
By following these revisions to the regulations and import/export requirements for the major world markets for PPE, manufacturers will be able to ensure their products reach those most in need in the fastest time possible and will be able to be part of the overall medical community’s effort to contain the virus and avoid its further spread.
For further information on this topic, I recently participated in a webinar focusing on “Regulatory and IP strategies in the time of COVID-19”. In the time available, I discussed the situation facing manufacturers navigating regulations relating to the Australian marketplace.
Notified Bodies (NBs): An organisation that has been designated by a member state to assess the conformity of certain products with the applicable essential technical requirements before they are placed on the EU market.
Member States: State which is a member of the European Union
Market Surveillance Authorities: Market Surveillance Authorities monitor, and where appropriate, enforce the requirements of European product safety law.
If you would like to view the full webinar hosted with FB Rice please follow the link below:
Regulatory and IP strategies in the time of COVID-19
May 12, 2020