Beware nasal sprays registered as medical devices

As you may know, there are nasal sprays that are registered as 'medical devices' in Europe. This recent journal article is an indictment of the regulatory system that allows such products on the market:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8150360/

Here's a couple of useful quotes:
"The prerequisites [for medical devices] clearly differ from the regulatory requirements needed for registration as a medicine. Regulations for MDs [medical devices] are much less stringent, as there is no need to prove efficacy and safety of MDs in clinical trials prior to launch...There is no evaluation or approval required by the European Medicinal Agency. Only notification with a competent authority is needed in one market from the European Union, selected by the manufacturer...MDs are directly available over the counter (OTC) in the European Economic Area (EEA) market and promoted directly to the consumer, while claims or leaflet contents are not controlled by medicinal authorities."

The study evaluated one such nasal spray that claimed to "protect against respiratory viruses, and to reduce and shorten symptoms of common cold," although their social media also promoted that it kills 98.3% of SARS-CoV-2 (COVID-19 virus), as well as rhinovirus, adenovirus, influenza and respiratory syncytial virus (RSV). However, the study found no real clinical evidence to support their claims, and raised serious concerns about safety and unintended consequences (e.g., facilitating mutations of SARS-CoV-2).

In conclusion, they ask the question: "why are medical devices intended for repeated oral or nasal administration not regulated like medicines?"
It's a great question. In Europe at least, manufacturers are using the medical device loophole to fast-track nasal sprays onto the market, and then promote them as treatments for COVID-19 and other respiratory infections, with virtually no human clinical efficacy data.

As I have stated previously, Nasodine Nasal Spray is a medicine and has been evaluated by the TGA as such. While this process can be long and not without some frustration, it ensures the quality, safety and efficacy of therapeutic products that reach the Australian market.