Yikangshengyuan’s core competitiveness stems from a professional team deeply rooted in medical device regulatory affairs, equipped with profound regulatory expertise and hands-on practical experience. Our team members are not merely industry specialists, but also guardians and partners standing beside enterprises throughout their compliance journey. The core team members boast an average of over 10 years of experience in medical device regulation, having previously served at the Center for Drug Evaluation, provincial drug administrations, and world-renowned medical device manufacturers. They possess an in-depth grasp of the underlying logic and implementation details of China’s medical device regulatory framework. Grounded in regulatory rules, armed with professional expertise, and bound by a strong sense of accountability, we support clients to forge steady progress amid complex compliance landscapes.

I. Team Structure: Deep Integration of Regulatory Knowledge and Practical Execution

Our team consists of four core divisions. Through specialized expertise and cross-department collaboration, we deliver full-lifecycle compliance services covering the entire medical device value chain:

1. Regulatory Expert Team: Pioneers of Policy Interpretation

• Team Composition: Composed of former NMPA reviewers, senior regulatory officials from provincial drug administrations, and global regulatory specialists, with an average of over 15 years of industry experience.

• Core Capabilities: Real-time tracking of global and domestic medical device regulatory updates, including the Regulations on the Supervision and Administration of Medical Devices, Measures for the Registration and Filing of Medical Devices, and Good Manufacturing Practice for Medical Devices. We deliver precise analysis of policy impacts on enterprises. For instance, in response to NMPA’s Special Review Procedure for Innovative Medical Devices, the team rapidly develops compliant application strategies to help enterprises leverage fast-track channels for accelerated market launch. Amid the mandatory rollout of the UDI (Unique Device Identification) system, we proactively assist clients in designing coding rules, data submission workflows, and end-to-end traceability frameworks to ensure zero compliance delays.

• Service Highlights: Monthly release of a Regulatory Update Brief featuring in-depth policy analysis paired with real industry cases. We host special seminars for major regulatory revisions (e.g., expansion of the Marketing Authorization Holder system, new clinical trial rules) to provide forward-looking guidance for enterprises.

2. Registration Affairs Team: Accelerators for Product Market Access

• Professional Background: All team members hold years of hands-on experience with NMPA registration filings, fully versed in the full lifecycle of domestic and imported medical device registration, with proven expertise in handling complex applications for Class III and innovative medical devices.

• Professional Services: End-to-end support spanning product classification determination, technical dossier compilation, clinical trial protocol design, registration submission, and response to deficiency letters. As a case in point, for a high-risk imported medical device, our team restructured its technical dossier and pre-simulated review inquiries, cutting the registration timeline by 30%. When responding to official deficiency letters, our precise grasp of review priorities enables us to quickly formulate supplementary data plans, drastically boosting approval rates.

• Tools & Databases: Self-developed registration management system integrated with a library of historical review cases and risk early-warning modules, leveraging data-driven workflows to lift filing efficiency and approval success rates.

3. Post-Market Supervision Team: Lifecycle Compliance Guardians

• Professional Qualifications: Team members include former NMPA adverse event surveillance specialists and quality management system auditors, holding ISO 13485 internal auditor certifications.

• Core Responsibilities: Establish full post-market compliance systems covering adverse event monitoring, post-market re-evaluation, quality management system maintenance, and product recall management. Our proprietary 7×24-hour adverse event response mechanism ensures investigation initiation within 2 hours of receiving a suspected incident, with preliminary reports finalized within 48 hours to fully meet NMPA statutory deadlines. We conduct regular quality audits and mock unannounced inspections to help enterprises identify risks in advance and avoid regulatory penalties.

• Technical Support: AI-powered intelligent analysis of market feedback data to flag latent risk signals, paired with manual review to generate customized compliance advisory reports.

4. International Compliance Support Team: Bridges for Cross-Border Regulatory Alignment

• Core Advantages: Bilingual proficiency in Chinese and English regulatory documents, comprehensive familiarity with international standards including FDA, EU MDR, and ISO, and extensive cross-border registration and compliance experience.

• Service Scope: One-stop China market access solutions for overseas manufacturers, including domestic agent duty fulfillment, cross-border quality agreement drafting, and overseas audit coordination to ensure full alignment with Chinese regulatory requirements. Representative achievement: Supported a European medical enterprise in completing China’s first commissioned manufacturing filing under the Marketing Authorization Holder system, enabling localized production and compliant domestic operations.

II. Team Core Competitiveness: Regulatory Expertise Drives Professional Value

Our team’s competitive edge is built on profound insight into China’s medical device regulatory system and accumulated real-world practice:

1. Regulatory Decoding Capability: Team members have participated in multiple NMPA regulation drafting and revision seminars. We interpret policy intent and actionable implementation roadmaps from a regulatory authority’s perspective. For the Technical Guidelines for Clinical Evaluation of Medical Devices, we not only clarify clause requirements but also design tailored clinical evaluation pathways (e.g., exemption from clinical trials, equivalent product comparison) aligned with each client’s product characteristics to satisfy review standards.

2. Proactive Risk Mitigation:  Dual-layer regulatory + technical review embedded at the product R&D stage to conduct early compliance assessments. For an innovative biomaterial medical device, our team identified special NMPA biocompatibility testing requirements upfront, eliminating costly R&D detours caused by misaligned development directions.

3. Industry Resource Network: Sustained open communication channels with NMPA, provincial drug administrations, testing laboratories, and clinical trial institutions to guarantee timely, authoritative policy and regulatory intelligence. We also maintain an expert think tank in partnership with universities and industry associations to resolve complex technical challenges.

4. Data-Driven Intelligent Operations: Our self-developed compliance management system integrates regulatory databases, case archives, and risk prediction models, utilizing data visualization to streamline decision-making. The system automatically matches product specifications against the latest regulatory mandates and generates personalized compliance checklists.

III. Team Values: A Shared Responsibility Community, Not Merely a Service Vendor

We firmly believe medical device compliance is a zero-sum undertaking—our clients’ success defines our mission. We reject the superficial "nominal agent" model and stand side-by-side with clients as a shared responsibility community:

1. Shared Risk Bearing: As the designated Domestic Responsible Person, we voluntarily assume joint and several liabilities as stipulated by regulation, formalizing shared risk agreements that integrate clients’ compliance risks into our internal management framework.

2. Deep Collaborative Integration: Our team embeds itself into clients’ product development and operational workflows, delivering accompanying compliance support spanning early regulatory consultation through long-term post-market compliance maintenance. We regularly attend client executive meetings to deliver strategic compliance recommendations, and assign dedicated on-site specialists to support high-risk projects.

3. Transparent Collaboration: A dedicated exclusive compliance platform enables real-time synchronization of project progress, risk statuses, and mitigation measures to guarantee full information transparency. All material compliance decisions undergo joint review with clients to reach mutually agreed solutions.

IV. Team Track Record: Trust Forged Through Proven Capability

• Successful Cases: We have supported over 200 enterprises to secure NMPA registration certificates, including more than 50 Class III medical devices and 20+ innovative medical devices, with a 98% registration approval success rate. We have assisted over 10 overseas manufacturers in realizing localized production via commissioned manufacturing filings, and successfully managed more than 30 major adverse event incidents without triggering any regulatory penalties.

• Industry Recognition: Our senior specialists are frequently invited to speak at official NMPA regulatory seminars; our proprietary compliance digital tools have won industry innovation awards.

• Client Testimonial: “The Yikangshengyuan team are far more than compliance experts—they are our strategic partners. Their deep regulatory experience and unwavering accountability allow us to expand our footprint in the Chinese market with complete peace of mind.” — Asia Pacific CEO, Multinational Medical Device Enterprise

V. Future Outlook: Continuous Evolution to Safeguard Compliance and Innovation

Against the backdrop of tightening medical device supervision—including full-scale rollout of the Marketing Authorization Holder system, new review rules for AI medical devices, and digitalized post-market regulation—our team maintains industry-leading expertise through continuous learning and practical execution:

• Regular participation in regulatory training hosted by NMPA and global international organizations to continuously update our knowledge base.

• Ongoing investment in intelligent compliance tool R&D to boost automation and precision of regulatory workflows.

• Expansion of specialized compliance capabilities for emerging sectors including AI medical products, digital therapeutics, and regenerative medicine.

Closing Remarks: Expertise as Our Shield, Accountability as Our Anchor

Within the medical device industry, compliance is an enterprise’s lifeline, and a specialized regulatory team stands as the great wall defending that lifeline. Yikangshengyuan’s team draws strength from profound regulatory expertise, sharpened by decades of hands-on practice, and united by shared accountability to help clients strike the optimal balance between compliance and innovation. We recognize that every approved registration certificate, every properly resolved adverse event, and every fully operational quality management system bears direct impact on patient health and enterprise sustainability. Guided by a reverent, cautious mindset, we uphold our professional commitments and safeguard industry trust.

Partnering with Yikangshengyuan means more than purchasing compliance services—it means securing a long-term regulatory partner who shares your growth and bears joint accountability alongside you.