MiYuan Consulting Files Prospectus to Accelerate Global Market Access for IVD Companies
In the post-pandemic era, competition in the in vitro diagnostics (IVD) market remains intense. As the IVD industry continues to expand, IVD technologies advance, and companies strengthen their capital bases, they are equipped with greater financial resources, enhanced technological capabilities, and increased confidence to expand into overseas markets. Initially, the pandemic triggered a surge in demand for medical devices such as face masks, protective suits, and forehead thermometers. Subsequently, COVID-19 diagnostic reagents became the flagship products driving IVD exports, effectively creating an entry point for Chinese IVD companies into global markets and accelerating the development of the IVD industry.
Chinese IVD companies’ enthusiasm for global expansion is driven by the market’s immense potential and development opportunities, as well as their desire to tap into the continuously expanding international market. According to statistics from the China Chamber of Commerce for Import and Export of Medicines and Health Products, in the first half of 2022 alone, China’s exports of major in vitro diagnostic reagents amounted to approximately USD 7.909 billion, representing a year-on-year increase of 288%. Among these, exports of self-test reagents reached USD 6.888 billion, accounting for a significant 87.09% of the total.
During the COVID-19 pandemic, Chinese in vitro diagnostics (IVD) companies accelerated their global expansion strategies. The urgent need to bring a large volume of IVD products to international markets spurred the emergence of specialized regulatory consulting teams to meet these demands. Amid this trend, Miyuan Company was established.
Hua Wenzhi, Head of Business at Miyuan Consulting, stated, “During our communications with enterprises, we observed that they encounter numerous difficulties and challenges in international regulatory registration. Leveraging our extensive experience and in-depth understanding of the healthcare industry, coupled with our familiarity with regulations and registration processes, our team is well-equipped to assist companies in resolving these international registration hurdles quickly and effectively. This capability was a key factor in the decision to establish the company. In summary, Miyuan Consulting was founded based on our profound industry insights and driven by the commitment to provide rapid, high-value services that help enterprises overcome their challenges.”
Currently, Miyuan Consulting focuses on clinical trials and certification/registration guidance, providing customized services to help in vitro diagnostic (IVD) companies rapidly obtain market access qualifications.
In recent years, China’s in vitro diagnostics (IVD) industry has experienced rapid growth, with a progressively mature industrial chain. Offering high-quality products at competitive prices, Chinese IVD companies have gained the capability to expand into global markets. However, international expansion requires comprehensive capabilities across multiple domains, including product research and development, regulatory registration and market access, supply chain integration, as well as marketing and after-sales services.Very few in vitro diagnostic (IVD) companies possess the capability to independently navigate the entire overseas expansion value chain. The majority achieve global market entry through partnerships, acquisitions, or other collaborative strategies.
Regulations and standards in the field of in vitro diagnostics (IVD) vary across different countries and regions. Companies must comply with the standards and regulations of each target country to ensure the quality and safety of IVD products. However, most companies currently face obstacles such as inability to meet regulatory requirements, difficulties in conducting overseas clinical trials smoothly, and high registration costs coupled with prolonged timelines.
Hua Wenzhi, Head of Business at Miyuan Consulting, stated, “In the registration and certification process, the higher the product’s risk classification, the greater the regulatory hurdles. Clinical trials represent the most complex and challenging component. For products classified as high-risk, companies must invest substantial financial resources, time, and effort. Furthermore, as global regulations continue to evolve and update, regulatory affairs (RA) professionals require more time to accumulate expertise and engage in ongoing learning. Given the variations in laws and regulations across different countries and regions, they must pursue systematic and comprehensive training while maintaining the ability to keep pace with regulatory changes through continuous education.”
Miyuan Consulting helps enterprises address the most costly and challenging aspects of overseas clinical trials and product registration.With years of experience in the healthcare sector, the Miyuan team comprises professionals from top-tier global medical device consulting firms, as well as regulatory affairs (RA) experts and overseas marketing specialists from industry enterprises. Leveraging this expertise, the team has successfully navigated various challenges since formally entering the in vitro diagnostics (IVD) field, helping numerous companies expedite their product registrations.
The company can undertake clinical trial projects that meet the registration requirements for medical devices and in vitro diagnostic (IVD) devices in multiple countries, providing enterprises with end-to-end solution services to accelerate overseas registration efficiency and reduce costs.
It is worth noting that, leveraging its in-depth familiarity with regulations across various countries and regions, MIYUAN Consulting enables companies to ensure their clinical trial reports comply as closely as possible with the regulatory requirements of multiple jurisdictions. This approach helps clients save costs during subsequent registration filings in additional countries, streamlining the clinical trial and product registration processes while minimizing detours.
Currently, Europe and the United States remain the primary destinations for Chinese companies expanding overseas. Europe boasts abundant medical resources and advanced medical technologies. With 27 member states in the European Union, CE certification can be converted to cover multiple countries, offering broad market applications, making it a key destination for Chinese IVD (In Vitro Diagnostics) enterprises going global. Although competition in the United States is intense, its market potential is substantial, with the U.S. medical device market accounting for over 30% of the global share. Miyuan Consulting has accumulated extensive project experience in both Europe and the United States.
Furthermore,Southeast Asian countries such as Thailand are emerging as new destinations for overseas expansion.The healthcare market in Southeast Asian countries is developing rapidly, and Chinese IVD companies have also recognized the tremendous potential of this region. The demand for conducting clinical trials and product registrations in Thailand is rising quickly.
On one hand, emerging markets in Southeast Asia, such as Thailand, currently face less competitive pressure and exhibit higher brand recognition for Chinese companies. On the other hand, while certification and registration processes in Europe and the United States are highly competitive, expanding into the Southeast Asian market may offer enterprises a valuable opportunity to overtake competitors. In 2021, Thailand ranked fifth out of 195 countries in the Global Health Security Index. As a major tourist destination with a diverse population, Thailand is well-positioned to meet the requirements for ethnic diversity in clinical trials. Conducting clinical trials in Thailand can significantly accelerate regulatory approval across Southeast Asia, enabling rapid market entry.
Hua Wenzhi explained, “According to the European Union’s Common Specifications (CS), products covered by the CS must undergo clinical performance studies in European populations. For products without ethnic differences, clinical trials can be conducted in Thailand to improve efficiency and reduce costs. For instance, while clinical trials for routine in vitro diagnostic products typically take around 6–8 months in Europe, they can usually be completed in Thailand within 3–4 months, cutting the timeline by at least half and lowering costs.”
Miyuan Consulting maintains deep collaborative partnerships with clinical hospitals in Thailand, enabling it to efficiently assist enterprises in conducting clinical trials, clinical evaluations, and related activities.Previously, Miyuan Consulting successfully assisted an IVD company in accelerating the completion of a clinical trial project in Thailand within one month.
Now that the peak of the pandemic has passed, demand for COVID-19 test kits in overseas markets is declining. However, trust and acceptance of Chinese products in these markets are rising significantly. Global expansion has become an inevitable trend, encompassing areas including but not limited to point-of-care diagnostics, women’s health, cancer screening, and infectious disease diagnosis. In the post-pandemic era, companies must leverage their strengths and unique characteristics to develop a more diversified portfolio of flagship products that align with market demands, accelerate market access, and facilitate the international rollout of more high-quality products.
Hua Wenzhi assessed: “Government support for the medical device industry will continue to intensify, the policy environment is constantly improving, and global demand is rising, providing companies with more opportunities to expand overseas. The trend of going global has always existed; what matters is how to gain insights into market needs and select the right strategic direction. Companies need to make concerted efforts in product portfolio planning, brand building, and performance quality. We believe that an industry watershed moment will soon emerge, particularlyOver time, regulatory oversight in various countries will progressively intensify and become increasingly stringent—an irreversible trend. In this context, companies that are the first to secure market access approvals will gain a competitive advantage.”
To date, Miyuan Consulting has served nearly 100 enterprises, successfully helping clients obtain market access qualifications in multiple countries. With substantial demand for Chinese in vitro diagnostics (IVD) and medical device companies to expand overseas, Miyuan Consulting will continue to assist outstanding domestic and international IVD and medical device enterprises in achieving strategic development and cultivating compliance talent, jointly realizing the vision of Chinese companies going global. “We may not necessarily help companies move faster, but we hope to go further together with them!”