Maris Regulatory Consulting: A Decade of Expertise in Medical Device Regulations, Building a Premier CRO in China
Medical device product registration is a mandatory pathway to market entry, with clinical trials during the registration process being particularly costly, time-consuming, and labor-intensive. As social division of labor becomes increasingly specialized, more companies are opting to outsource these tasks to professional, efficient, and experienced third-party Contract Research Organizations (CROs) to achieve safer and faster market access.
In terms of the market, according to data from the “Innovation Report on the Medical Device R&D Outsourcing Services Industry” recently released by VCBeat, the market size of China’s medical device R&D outsourcing services industry reached RMB 10 billion in 2019. The compound annual growth rate is expected to exceed 20% in the coming years, indicating that the medical device R&D outsourcing services industry remains a blue ocean.
In terms of policy, on August 1, 2019, the National Medical Products Administration (NMPA) issued the *Notice on Expanding the Pilot Program of the Medical Device Registrant System*, extending the pilot program to 21 provinces and decoupling medical device registration from production. The implementation of the Medical Device Registrant System pilot will expand the scope of contract research and development services for medical devices from clinical trials and registration to include R&D and manufacturing stages, thereby further broadening the business scope of companies providing such outsourcing services.
As a rapidly evolving field, what challenges and opportunities lie ahead for the medical device registration industry? How will companies strategize their market positioning? In response to these questions, VCBeat conducted an exclusive interview with a leading medical device registration consulting firm—Beijing Maris Pharmaceutical Technology Co., Ltd. (“Maris Registration Consulting”).
In the past, companies registering medical devices were generally referred to as CROs. As the name suggests, a CRO is a third-party contract research organization. However, Wang Yang, founder of Maris Registration Consulting, envisions building an advisory firm with professional consulting capabilities.
Why hold such beliefs and vision? “Having spent fifteen years in medical device registration, I have taken detours and hit roadblocks in this field, but these experiences have also shaped Maris into what it is today. Through these mistakes and continuous updates, I have gained a deeper understanding of device registration. What we need is not just an execution team, but rather a consultancy that can provide clients with strategies and guidance based on regulations and experience,” Wang Yang told VCBeat.
“Under the old regulations prior to 2014, the registration process for domestically produced medical devices was far more complex than that for imported ones, requiring clinical trials. At that time, many domestic companies had to wait three years or even longer to obtain their registration certificates. Against this backdrop, I wondered whether I could help domestic products avoid unnecessary detours and secure market approval for medical devices as quickly as possible.” Recalling the founding of his company, Wang Yang still remembers it vividly.
However, the medical device sector encompasses a vast and diverse array of products, with tens of thousands of subcategories and a continuous influx of innovative devices. Consequently, the industry imposes stringent requirements on professional expertise. To address this, Maris Regulatory Consulting has built a multidisciplinary team that includes not only medical professionals but also experts in materials science, electrical engineering, manufacturing, and other relevant fields.
How to manage such a large pool of talent? Maris adopts a team-based approach by dividing its staff into specialized groups. For instance, there are teams dedicated to electrical products, while others focus exclusively on in vitro diagnostic (IVD) reagents or passive medical devices. “Over the past nearly 12 years, we have accumulated extensive regulatory registration experience, complemented by almost six years of clinical trial expertise. This has allowed us to develop a wealth of industry knowledge and best practices,” said Wang Yang.
In terms of team composition, Maris Consulting is a company predominantly staffed by professionals born in the 1980s, with three generations—senior, middle-aged, and young—working side by side. This structure not only maintains the company’s vitality but also ensures the sharing of expertise among top talents. The company has recruited seasoned industry experts while simultaneously introducing fresh talent each year through both experienced hires and campus recruitment. Furthermore, it has established the Maris Training Academy, conducting up to 150 internal training sessions annually and providing high-quality training opportunities for external clients.
In addition to cultivating a highly specialized and deeply expert talent pool, Maris has positioned its regulatory consulting services to focus exclusively on the medical device sector. This strategic focus is driven by two key factors. First, the wide variety of medical devices entails relatively high learning costs; therefore, only through deep specialization can we deliver precise regulatory strategies to our clients. Second, greater industry immersion yields richer experience and deeper understanding, enhancing our ability to mitigate risks and better assisting clients in obtaining regulatory approvals at an earlier stage.
It is precisely under this philosophy of “precision, specialization, and depth” that Maris has been attracting an increasing number of clients for regulatory registration consulting. Currently, its client base primarily falls into two major categories. The first comprises foreign enterprises, including several Fortune Global 500 companies. “These companies introduce innovative medical device products that are not yet available in mainland China. Although these large multinational corporations have their own in-house regulatory affairs teams, they still seek professional consultancy and guidance when dealing with complex and innovative products.” The second category mainly consists of leading domestic medical device manufacturers, many of which are publicly listed companies in China’s medical device sector.
“We place great emphasis on service quality,” stated Wang Yang. In addition to maintaining a strong customer repurchase rate, Maris Regulatory Consulting has attracted numerous clients through word-of-mouth referrals. To date, the company has served over 600 clients and secured more than 1,000 Class II and Class III medical device registration certificates. Its business scope continues to expand: beyond its Beijing headquarters, Maris Regulatory Consulting has established offices in Seoul, Taipei, Shanghai, Shenyang, and Shijiazhuang, with onsite personnel stationed in more than 17 provinces and municipalities across China.
Certainly, as enterprises expand in scale, relying solely on word-of-mouth becomes insufficient to support rapid growth. In response, Maris Registration Consulting has made several efforts in promotional activities over the past two years. For instance, Maris participates annually in both the spring and autumn medical device expos, as well as specialized exhibitions in fields such as in vitro diagnostic reagents and orthopedics. Furthermore, Maris Registration Consulting conducts professional training sessions and seminars focused on interpreting new regulations issued by the National Medical Products Administration (NMPA), while maintaining collaborations with the Clinical Branch and the Innovation Branch under the China Association for Medical Devices Industry (CAMDI).
In addition to regulatory consulting and clinical CRO services, Maris Group also has an SMO team focused on medical device clinical trials.
“Looking at the development over the past few years, there are currently no unicorn companies specializing in SMO services for medical devices,” Wang Yang told VCBeat. Due to the complexity and wide variety of medical devices, hospitals tend to be cautious about high-risk devices and those requiring long-term follow-up, thus mandating the assignment of Clinical Research Coordinators (CRCs) to assist physicians in conducting clinical trials.
To address this market pain point, Maris Regulatory Consulting began establishing a dedicated SMO team for medical devices in 2017. “The most fundamental personnel in clinical trials are our Clinical Research Coordinators (CRCs); they constitute the core backbone of the entire clinical trial process,” stated Wang Yang. Regarding compliance in clinical trials, physicians generally have limited familiarity with regulatory requirements; therefore, professional CRCs are needed to assist physicians in organizing non-clinical data. Furthermore, throughout the clinical trial process, sponsors—i.e., pharmaceutical and device companies—are primarily concerned with timelines. The involvement of CRCs can accelerate the overall trial progress, particularly during the initial patient screening and follow-up phases.
Through two years of dedicated efforts, the SMO business of Maris Registration Consulting has expanded nationwide, covering 44 hospitals, and has become the preferred SMO supplier in the medical device sector for some of these institutions.
Regarding the future development of the medical device CRO industry, Wang Yang indicated that two trends are worth noting.
First, the medical device CRO sector will become increasingly consolidated. “As regulations grow stricter and market demands for clinical trial compliance rise, product registration is becoming more challenging. When companies incur higher R&D and clinical trial costs, they inevitably seek experienced medical device regulatory consulting firms to ensure quality and efficiency. Consequently, standalone CROs lacking dedicated regulatory affairs teams will struggle to survive, while firms with greater specialization will have better opportunities. Our aim is to carve out a distinct niche by establishing a medical device regulatory consulting firm that combines professional advisory expertise with strong execution capabilities.”
Second is the extension of the industrial chain. “As medical device CRO companies become increasingly specialized and deeply engaged, their business scope will not only cover service segments but also extend upstream into R&D and investment, and downstream into sales and marketing services. By integrating the entire industry chain, these companies can maximize the strategic role of clinical services and drive healthy, rapid corporate growth.”