The global medical device regulatory affairs market size is expected to be worth around US$ 11.6 billion by 2030 from valued at US$ 5.5 billion in 2020, growing at a CAGR of 10.6% during forecast period 2021 to 2030.
The global medical device regulatory affairs market size is expected to be worth around US$ 11.6 billion by 2030 from valued at US$ 5.5 billion in 2020, growing at a CAGR of 10.6% during forecast period 2021 to 2030.
Technological advancements in medical devices such as AI/Machine learning, increasing trends of portable and smaller devices, and government regulations are driving the market.
Medical equipment regulation is a vast and rapidly changing field that is often complicated by legal challenges. Even within one regulatory framework, legal terms and their definitions are not always consistent. As technology expands, software, machine learning, and algorithms become an essential component of an increasing number of digital health resources. This presents new challenges as an increasing number of instruments fall under the regulatory framework.
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Also, due to COVID-19, the global regulatory landscape is changing for all medical device companies. Exemptions have been granted by countries ranging from China to Australia and beyond. China has intensified the registration of medical protective clothing. Respirators, protective gear, thermometers, and surgical masks are exempt from registration requirements in Singapore.
| Report Scope | Details |
| Market Size by 2030 | US$ 11.6 Billion |
| Growth Rate from 2022 to 2030 | CAGR of 10.6% |
| Largest Market | North America |
| Fastest Growing Market | Asia Pacific |
| Base Year | 2021 |
| Forecast Data | 2022 to 2030 |
Report Highlights
The regulatory writing and publishing segment dominated the market for medical device regulatory affairs with 36.10% of revenue share in 2020. This is largely attributed to the fact that these services are provided from the early stages of product development to premarket approval, as high-quality documentation is essential for regulatory affairs in order to escape delays in the approval process.
The segment of product registration and clinical trial services is anticipated to witness the fastest growth rate of 30.1% over the forecast period. The clinical trial for a medical device and regulations to manage the studies are very different.
The outsourcing segment dominated the market for medical device regulatory affairs with the largest revenue share of 61.0% in 2020. This is largely attributed to the lack of an in-house regulatory team. Besides, the advantages such as cost and time saving associated with the outsourcing of these services are contributing to the market growth.
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Besides, new regulatory challenges, such as medical device regulation and in vitro diagnostic device regulation in Europe, as well as regulatory cybersecurity scrutiny, make market launch and recertification timelines difficult. It is incredibly challenging for businesses to manage regulatory hurdles with unskilled personnel which drives the demand of outsourcing these services.
The therapeutics segment led the market for medical device regulatory affairs and accounted for the largest revenue share of more than 56.0% in 2020. The segment is also projected to witness the fastest CAGR of 9.10% during the forecast period. This may be attributed to the increasing prevalence of various chronic diseases such as cancer, diabetes, cardiovascular diseases, and respiratory disorders that create demand for advanced therapeutic products.
Asia Pacific dominated the medical device regulatory affairs market and accounted for the largest revenue share of 47.1% in 2020. The region is also expected to grow at a significant rate during the forecast period. This is due to the highly evolved regulatory systems in countries like Australia and Japan.Regional regulatory initiatives in Africa, Asia, and the Americas are evolving to promote the harmonization of regulatory requirements across countries, lowering market entry barriers for manufacturers that can lead to lower product prices, encourage manufacturers to register their products in more countries, and contribute to a more sustainable total market for health products.
Key Players
- ICON Plc
- Emergo
- Covance
- Freyr
- Promedica International
- Medpace
- IQVIA Holdings
- Intertek Plc
- SGS SA
- Integer Holdings
Market Segmentation
- Services Outlook
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Other Services
- Type Outlook
- Diagnostic
- Therapeutic
- Service Provider Outlook
- Outsource
- In-house
- Regional Outlook
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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