Medical Device Vigilance Market is Anticipated to Witness High Growth Owing to Stringent Regulatory Framework

Medical Device Vigilance Market


Medical devices play an essential role in treating diseases and improving patients' quality of life. However, there are chances that these devices will have adverse events affecting patients' health. As a result, medical device vigilance aims to collect and monitor information on incidents concerning medical devices and take preventive measures. The global medical device vigilance market is vital considering strict regulations that require timely reporting of adverse events linked to medical equipment.


The Global Medical Device Vigilance Market is estimated to be valued at US$ 103.36 Mn in 2024 and is expected to exhibit a CAGR of 9.0% over the forecast period 2024 to 2031.

Key Takeaways
Key players operating in the medical device vigilance market are BrainsWay, Magstim, Nexstim, Salience, and MagVenture A/S, eNeura Inc. These companies ensure risk-free use of medical equipment through continuous vigilance.
Key opportunities in the market include increasing demand for post-market surveillance and patient safety initiatives. Vigilance systems help identify device-related issues early, leading to corrective actions.
Global expansion is another important area for market players. As awareness regarding medical device safety rises across countries, companies are strengthening their presence internationally through partnerships and acquisitions.

Market Drivers
Stringent regulatory framework mandates timely surveillance and reporting of adverse incidents linked to medical devices. Regulations aim to boost patient safety and ensure devices meet acceptable safety and performance standards. Non-compliance can lead to penalties, affecting Medical Device Vigilance Market Growth.

Market Restrains
High costs associated with purchasing and implementing medical device vigilance software may restrict small and mid-sized organizations. Also, a lack of skilled professionals trained in using such software poses challenges. This hinders complete adherence to regulations, impacting the medical device vigilance market.

Segment Analysis
The Global Medical Device Vigilance Market can be segmented based on product type, application, end-user, and region. Based on product type, the transcranial magnetic stimulation (TMS) segment is dominating the market currently owing to its non-invasive nature and ability to treat various neurological and psychiatric conditions like depression, anxiety, migraine, Alzheimer's, Parkinson's etc. TMS devices use magnetic fields to cause a slight electric current in specific parts of the brain which helps in stimulating nerve cells and regulating neuronal connections without the need for surgery.

Regional Analysis
North America is currently the fastest growing as well as dominating regional market for medical device vigilance and is estimated to maintain its dominance during the forecast period. The high prevalence of target diseases, favorable reimbursement policies, advanced healthcare infrastructure, and presence of major key players in the region are some factors fueling the market growth. Asia-Pacific is anticipated to witness the highest CAGR owing to the rising healthcare expenditure, increasing awareness regarding mental health disorders, and growing medical tourism in countries like India, China and Singapore.

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