Golden Eagle Gains Industry Recognition in Aesthetic Medical Device Compliance Transformation

“At least for the next five years, medical aesthetics will remain a hotspot in the industry,” said Che Haoshuang, General Manager of Jinfeiying Pharmaceutical and Medical Device Consulting Technology Service Group (hereinafter referred to as “Jinfeiying”).

This is a group company that provides integrated services encompassing one-stop regulatory registration and certification consulting for medical devices, as well as software development management. It is committed to delivering comprehensive, end-to-end professional solutions for the medical device industry to domestic and international enterprises, covering every stage from product initiation, design and development, and establishment of product technical requirements, to clinical trials, and the establishment and operation of quality management systems.

Since 2017, the number of medical aesthetics companies among Jinfeiying’s clients has steadily increased, with CRO services for medical aesthetics products—particularly active medical aesthetics devices—becoming a key pillar of Jinfeiying’s revenue.

Jin Feiying’s strategic focus on the medical aesthetics sector stems from its optimistic outlook on this market. According to Frost & Sullivan, the size of China’s medical aesthetics market grew from RMB 99.3 billion in 2017 to RMB 189.1 billion in 2021, representing a compound annual growth rate (CAGR) of 17.5%. It is projected to reach RMB 638.2 billion by 2030, at a CAGR of 14.5%. Among various segments, energy-based device procedures—such as those utilizing ultrasound, radiofrequency, and laser technologies—are regarded as high-potential niches due to their high consumer acceptance.

However, as the market rapidly expands, regulatory oversight of medical aesthetic devices has become increasingly stringent. For instance, in 2018, the National Medical Products Administration (NMPA) announced that intense pulsed light (IPL) hair removal products would be regulated as Class II medical devices. In 2022, the Announcement on Adjusting Certain Contents of the Medical Device Classification Catalog stipulated that radiofrequency treatment instruments and radiofrequency skin treatment instruments within the category of non-ablative radiofrequency treatment equipment would be regulated as Class III medical devices.

As policies begin to tighten, medical aesthetics device manufacturers face only two options: either painfully withdraw from this market, or press on with diligent research and development to secure regulatory approval.

However, for enterprises striving to build a future in this industry, critical questions have emerged: how to establish technical specifications, design appropriate product parameters and operational procedures, develop animal and clinical trial protocols in accordance with regulatory requirements and conduct them in a lawful and compliant manner, and secure registration certificates more efficiently. The existence of Jinfeiying is precisely aimed at helping enterprises better address these challenges.

As a comprehensive group company providing one-stop registration and certification consulting for medical devices as well as software development management services, King Flying Eagle’s service (product) portfolio primarily comprises two aspects: first, Contract Research Organization (CRO) services for medical devices; and second, related software development management services.

“Why does your business also involve software development and management services?” During the interview, VCBeat posed this question to Che Haoshuang, who offered a candid response: In the course of providing services, Kingfly Eagle identified that some clients had related software needs. To comprehensively meet these demands and enhance client stickiness, Kingfly Eagle developed pharmaceutical and medical device operation management software as well as UDI traceability management software, thereby addressing clients’ operational and product traceability requirements. “However, software development and management services account for only a small proportion of our revenue.”

Clinical Research Organization (CRO) services for medical devices, particularly CRO services for aesthetic medical devices, constitute the core business of Jinflying Eagle. In terms of market scope, Jinflying Eagle provides domestic CRO services in China as well as overseas market entry services for medical devices. Regarding product categories, the company offers registration and certification services for active devices, including lasers, intense pulsed light (IPL), red-blue-purple light therapies, radiofrequency (RF) devices, ultrasound devices, low- and medium-frequency electrical stimulation devices, and electronic delivery systems. It also provides registration and certification services for passive devices, such as medically recombinant collagen, sodium hyaluronate, needle-free injectors, and liquid film-forming dressings.

It should be noted that although medical aesthetic devices are currently the key product category served by Jinflying, the company is also providing domestic and international registration/certification services for other medical device products, including in vitro diagnostics (IVD).

Focusing on the registration/certification services for Golden Eagle Medical Aesthetic Devices, let us first examine its business operations in China.

As previously mentioned, within the medical device registration and certification services sector, Jinfeying is capable of providing enterprises with a “comprehensive, one-stop” professional solution for the medical device industry. This solution covers the entire lifecycle, from product initiation and team building, formulation of product technical requirements, and guided follow-up on inspection and testing, to clinical evaluation, clinical trials, and the establishment, operation, audit, and certification of quality management systems.

Two aspects of this comprehensive professional solution are noteworthy: first, Jinfeiying’s services are engaged from the early stages; second, its clinical trial protocol places significant emphasis on cost control while ensuring regulatory compliance.

By engaging at the early stage of product initiation, Kingflying’s primary objective is to assist enterprises in clarifying the landscape of major market products, identifying differentiated advantages, and helping them establish corresponding performance indicators and technical parameters. In other words, leveraging comprehensive market research and years of experience in medical device registration, Kingflying can help enterprises develop products with strong market competitiveness.

In terms of clinical trials, Kingfeiying first develops small-sample clinical trial protocols and formal clinical trial protocols tailored to the client’s needs and relevant regulatory requirements, assisting clients in managing compliance and controlling costs. Secondly, when selecting trial sites, Kingfeiying strives to control costs while ensuring full communication with the client and strict adherence to compliance standards. Finally, in addition to maintaining thorough communication with hospitals during the clinical trial implementation phase, Kingfeiying performs final reviews of materials such as clinical trial reports and animal study reports to ensure their compliance, thereby facilitating a smoother acquisition of registration certificates for its clients.

From these two points, we can see Jin Feiying’s precise grasp of customer needs and the professionalism with which it conducts its business. Looking at Jin Feiying’s overseas operations, one cannot help but be impressed by the breadth of its business footprint—from the United States to the United Kingdom, from Canada to Australia, and from Saudi Arabia to Japan, South Korea, and Southeast Asia. In these countries and regions, Jin Feiying is equally capable of helping enterprises obtain registration certificates or achieve certifications.

This is the complete business system of Jin Feiying.

How to Measure the Competitiveness of a Medical Device CRO Company?

In the interview, Che Haoshuang also shared his perspective. In his view, a medical device CRO company’s core competitiveness lies in its team, experience, resources, and professional, refined guidance.

Based on this, we will systematically deconstruct Jin Feiying’s core competencies in accordance with this standard.

Regarding team capabilities, Che Haoshuang defines them as comprising two components: first, team size (since, to a certain extent, a larger team enables a broader service scope, better meets diverse customer needs, and increases the likelihood of undertaking large-scale projects); and second, the professional competence of team members. So, what kind of team has Jin Feiying built?

According to Che Haoshuang, the Jinfeiying team currently comprises over 80 professional project and technical experts, nearly 30 of whom have more than 10 years of work experience. They possess extensive expertise in medical device registration and quality management system consulting, and have developed a precise understanding and mastery of regulations and standards in the pharmaceutical and medical device industry.

For example, Mr. Che Haoshuang, the General Manager, has nearly 30 years of experience in R&D, production, quality control, and comprehensive management within the pharmaceutical and medical device industries. He has provided technical consulting and training services to over 200 pharmaceutical and medical device companies, possesses extensive expertise in domestic and international technical standards and regulatory requirements for pharmaceuticals and medical devices, and has offered consulting and coaching services to numerous well-known medical device companies in the industry.

Wang Qin, Deputy General Manager of Jinfeiying, brings over 20 years of consulting experience in the medical device industry. He is well-versed in market access pathways for medical device products across various countries and possesses extensive knowledge of both macroeconomic and microeconomic aspects of the sector. To date, he has provided consulting and advisory services to support the market launch of more than 500 medical device products.

As for experience, it is a term that Che Haoshuang repeatedly emphasized during the interview. He considers it one of the most essential capabilities for medical device CRO companies. A proven track record serves as a compelling testament to credibility. With over 4,000 successful cases, Jinfeiying has established itself as a gold-standard brand, directly demonstrating its service capabilities and earning the trust of more than 3,000 clients.

In terms of resources, Jinfeiying has also established an industrial resource network that includes design firms, testing and certification agencies, hospitals for clinical trials, sterilization service providers, equipment suppliers, cleanroom construction contractors, and third-party logistics companies, providing strong support for the delivery of diversified CRO services.

Next, let us examine Jin Feiying’s capacity for refined guidance. This is primarily reflected in two aspects: First, during the specific service process, Jin Feiying “customizes” team staffing for each project, incorporating project consultants from various fields to assist enterprises in resolving all issues encountered throughout the registration process, thereby ensuring efficient completion of the registration workflow.

Second, to facilitate efficient project management, Jinfeying has independently developed a project management system that comprehensively addresses needs across marketing, sales, project services, and customer complaint handling. Currently, this system has obtained a Computer Software Copyright Certificate from the China National Intellectual Property Administration.

At this point, the four core competencies of Jin Feiying have been fully established.

At this stage, Jinflying has adopted three strategies to expand its market: first, conducting marketing through exhibitions and other events; second, leveraging word-of-mouth marketing; and third, establishing direct collaborations with relevant industrial parks. Currently, the third model is still in the exploratory phase.

In the final part of the interview, Che Haoshuang also conveyed this message to VCBeat: the medical aesthetics industry will remain one of the key growth areas in the healthcare sector. Therefore, Jinfeiying will continue to focus on the field of medical aesthetic devices, refine its capabilities, and further provide higher-quality CRO services to clients in the medical aesthetics industry.

Meanwhile, in addition to the medical aesthetics industry, Jinfeiying will also focus on other hot sectors in the medical device market, including surgical robots, digital therapeutics, and bioengineering products, to drive the efficient development of companies in these fields.

Furthermore, in terms of market expansion, Jinfeiying will prioritize supporting Chinese medical device manufacturers in their overseas ventures into Japan, South Korea, and Southeast Asia during the next phase, with plans to establish local offices in these regions. Companies interested in collaboration are welcome to engage in discussions and negotiations.

Finally, Che Haoshuang concluded, “At present, the industry is still plagued by disordered competition. As a company of modest scale, we hope to lead the industry toward standardized development and positively promote healthy competition.”