MedStar Creation Files IPO Prospectus: A Leading CRO Powering Global MedTech Innovation with Policy-Driven Strategy

In recent years, a series of policies—including the approval process for innovative medical devices, the selection catalog for domestically produced medical equipment, and the Guiding Opinions on Promoting the Healthy Development of the Pharmaceutical Industry—have explicitly called for strong support for domestic brands and locally manufactured devices, placing China’s domestic medical device industry at the forefront of policy-driven opportunities.

However, given the vast diversity of medical device categories and the continuous evolution of pre-market approval regulations, coupled with the deepening reform toward standardized clinical trials for medical devices, a large number of devices from small and medium-sized enterprises (SMEs) are encountering significant review challenges and policy risks during the registration application process.

Consequently, the demand for medical device CROs is rising rapidly.

MedCRO is a CRO company specializing in medical device registration and filing services. Established in 2011, the company is committed to providing enterprises with comprehensive one-stop solutions, including medical device registration and clinical trials.

Our services primarily include: new product design, development, and validation; regulatory submissions for innovative medical devices; product registration filings; testing agency services; clinical trial research; animal study protocol design and execution; production system consulting; GMP facility design and construction; and preparation of clinical equivalence evaluation reports. Our specialty lies in regulatory submissions and clinical trial research services for Class III implantable products. In other words, Mediscreation provides comprehensive services covering all aspects related to medical device R&D, production system establishment, and regulatory approval applications.

Since its establishment in 2011, Medthink has secured a solid leading position within the industry, ranking among the companies with the most comprehensive service offerings in the medical device CRO sector. The company consistently ranks at the forefront of the industry across key metrics, including service diversity, employee headcount, project volume, and the number of high-risk, high-complexity projects.

MediThink’s core team comprises elite professionals with frontline experience in regulatory affairs, testing, and clinical trial research from multinational corporations, leading domestic manufacturers, and regulatory consulting agencies. The team is well-versed in the CFDA regulatory framework and submission processes, boasting extensive and mature expertise in medical device registration services, along with professional and efficient operational management SOPs.

Through years of dedicated efforts and in-depth cultivation in the field of medical device registration, the company has accumulated substantial industry resources. According to VCBeat, Maidisichuang has currentlyFor Siemens, Olympus, Omron, Osstem, United Imaging, WEGO, Yuwell, and Kehua Bio-Engineeringhas provided high-quality services to well-known enterprises both in China and abroad,CumulativeSecured over 1,500 registration certificates for both domestically produced and imported medical devices. 

Looking at the entire medical device CRO industry to which Mediscreation belongs, it remains a vast blue ocean.

MedCRO CEO He Ping told reporters that the implementation of the new Measures for the Administration of Medical Device Registration in October 2014 systematically and comprehensively revised and upgraded the previous regulations, bringing the medical device CRO industry its greatest opportunity and challenge since 2000 and triggering significant changes in the industry ecosystem.

The substantial regulatory adjustments have had a profound impact on all companies providing medical device CRO services in the market. The mainstream service providers in the original CRO market—namely, those capable of offering only single registration and filing services—were hit the hardest and were the first to fade from the competitive landscape amid industry turbulence. In contrast, CRO companies that adapted to market developments and met customer needs, particularly those related to clinical trials, seized the opportunity and achieved robust growth.

However, given that the allocation of industry resources and the buildup of human capital require a certain period, there are only a handful of CRO firms nationwide capable of providing comprehensive, one-stop services for pre-market registration and filing of medical devices while covering a broad spectrum of product categories, including active medical devices, passive medical devices, and in vitro diagnostic reagents.

However, with the rapid development of China’s medical device industry and driven by favorable factors such as policy support, consumption upgrades, and technological innovation, both the actual and potential demand for CRO services among medical device manufacturers has shown a trend of rapid growth.

Medisinnov has conducted in-depth research on industry development, and through sampling questionnaire analysis of numerous manufacturers within the industry, it was found thatPre-market expenditures by domestic medical device manufacturers and importers on Contract Research Organization (CRO) services in China account for approximately 5% of their market sales revenue.Moreover, with the in-depth implementation of China’s regulatory requirements for medical device registration and filing, the proportion of these costs is likely to increase further.

In the face of significant changes in medical device registration and submission regulations, mature large-scale medical device enterprises with stable operations need to outsource certain business processes, or even entire workflows, to Contract Research Organizations (CROs) to overcome bottlenecks constraining the registration and submission process. For start-up medical device manufacturers and smaller-scale medical device distributors, outsourcing new products intended for market launch to CROs is even more critical from a cost-efficiency perspective, enabling them to obtain efficient external support and precise consulting services.

He Ping advises that companies, especially innovative medical enterprises, should involve CROs during the R&D phase. “Currently, some startup manufacturers work in isolation, first developing product prototypes before seeking assistance from CROs. However, during the regulatory submission process, we still identify numerous issues. Had we been involved from the outset, these problems could have been resolved at an earlier stage, thereby saving companies significant human, material, and financial resources, as well as time.”

As CROs have long been professionally engaged in the study and interpretation of industry laws and regulations, and possess a thorough understanding and profound insight into national standards, industry standards, technical review guidelines for medical devices, clinical medicine, mathematical statistics, animal testing, and production system requirements, they can help enterprises accurately and efficiently develop solutions that meet technical review requirements. This enables rapid acquisition of registration certificates, thereby ensuring swift market entry and subsequent sales of the products.

He Ping further noted that approximately half of the manufacturers (or projects) currently on the market engage third-party Contract Research Organizations (CROs) to handle their CFDA certification applications. As regulations governing medical device registration, clinical trials, and production system inspections become increasingly standardized, stringent, and detailed, the cost for medical device manufacturers and trading companies to independently build in-house teams capable of managing all aspects of these operations is rising significantly. More importantly, cultivating professionals in this sector requires practical project experience, and their development entails a considerable lead time. Consequently, among the existing client base, a growing number of enterprises are progressively outsourcing portions of their work to CROs.

MoreoverWith industry development and regulatory changes, the stickiness between CRO companies and their clients has been increasing. Clients’ demands for CROs, as well as the services CROs need to provide to enterprises, are showing a trend toward greater diversification and refinement.

According to relevant data, the global medical device market is growing at an annual rate of approximately 6%–7%, while China’s medical device market has seen an annual growth rate exceeding 20%.

“The market potential for medical devices in China is enormous. However, through exchanges with regulatory affairs professionals in the medical device industry both domestically and internationally, we have learned that the overall difficulty of regulatory submissions for medical devices in China has even surpassed that of Japan’s Ministry of Health, Labour and Welfare (MHLW), ranking second globally, only after the U.S. FDA,” said Heping.

Therefore, in recent years, Medisun has focused its development on expanding industry resources and building human resource reserves in China’s medical device CRO market, helping numerous partner companies rapidly obtain CFDA certification.

Regarding certifications for overseas markets such as the FDA and CE, Heping told reporters that Medisinnov would also expand steadily, centering on its China CFDA certification services while extending to other international certifications. Currently, most of Medisinnov’s clients are already leaders in their respective medical device segments. In the near future, guided and encouraged by the Belt and Road Initiative, these enterprises will serve as pioneers among Chinese medical device manufacturers, going global to sell in overseas markets and compete internationally.

In addition, Jiang Nan, Head of Operations at Medisun, stated, “We are committed to helping Chinese medical device companies efficiently pass CFDA reviews while also assisting them in understanding regulatory requirements across various countries and regions, thereby enabling them to quickly obtain the necessary registration certificates. For medical device manufacturers, laws and regulations are complex and ever-changing, necessitating the establishment of a comprehensive and systematic approach.”

“On the basis of giving sufficient attention, scientifically managing various tasks before medical devices are marketed, and at the same time finding CRO companies with high service quality and outstanding business capabilities to establish continuous and comprehensive cooperative relationships, is crucial for medical device companies to quickly obtain registration certificates, achieve sales revenue, gain investment returns, and even lay a leading position in the industry.”

2018 marked the eighth year since the establishment of Medisino. At the beginning of the new year, on January 16, the company secured tens of millions of RMB in Series A financing from Honghui Capital and Chongshan Capital (For details, please refer to VCBeat's previous reports.), marking the entry of Medisun into a new phase of development. Alongside the substantial growth of China’s medical device industry, and amidst the opportunities and challenges presented by profound reforms in medical device registration regulations, Medisun will undergo further rigorous testing. We look forward to the emergence of a benchmark enterprise in China’s medical device CRO industry.