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In 2021, the regulatory affairs market for global medical devices had been valued at $7bn, however this is expected to reach as much as $12.2bn by 2031, increasing at a CAGR of 5.8% over this period. This government regulatory affair specialises in regulated industries. These can include agrochemicals, pharmaceuticals, and medical devices. Regulatory affairs have a very specific use within the healthcare industry.

The regulatory function within the healthcare industry has proved critical in ensuring the ready availability of healthcare products around the world which are safe and effective. Professionals within regulatory affairs can include those who enforce regulatory compliance, as well as those working in the fields of quality assurance or clinical affairs.

Regulatory affairs experts on medical devices act as a bridge between that industry and various global regulatory bodies, such as the USFDA, MHRA, CDSCO, PFSB, or the TGA.

A new medical device can cost millions to produce, and any errors in development may have a significant influence on the company’s reputation. Because these medical devices play a deeply integral part in the lives of patients, and could aid in things like prevention or treatment of disease, or early diagnosis, it is crucial that the quality of the device is assured, which is the role of the regulatory device expert. They are also responsible for ensuring that all essential information about the device is accurately conveyed to the user, and any mistake, even if seemingly small, can lead to recalls, and potentially millions of wasted dollars.

The expectation is that the market will witness moderate growth during the next 9 years. This is likely down to the inventions and developments of advanced medical devices, which can be used to treat various kinds of disease, including cancer, cardiovascular, and infectious ailments, along with improvements in technology across a broad spectrum of the healthcare sector. Also, a surge in the geriatric population, alongside various advances in technology to meet the needs of all patients, may well factor in.

But there are also factors which it seems like will restrict market growth to some extent, such as the tall cost of being able to provide regulatory services, as well as an increase in cyber attacks on software-based medical devices. While these may have a slight impact, however, it will ultimately not stop the forecast for the increase of market value.