Deep NMPA Regulatory Expertise: A Regulatory Moat from Compliant Market Access to Shared Responsibility

In the medical device industry, regulations are not merely the gateway to market access but also the cornerstone and lifeline of sustainable business operations. Yikang Shengyuan's core strength is rooted in a profound understanding and forward-looking application of the Regulations on the Supervision and Administration of Medical Devices and their supporting regulatory frameworks. This enables us to construct a formidable regulatory moat within the highly specialized domain of "local agent/local responsible entity for imported medical devices."

We fully recognize that under current Chinese regulations, overseas medical device manufacturers cannot independently fulfill statutory obligations within China's territory. Consequently, designating a Chinese domiciled enterprise as its "local responsible entity" is a statutory prerequisite for product market entry. We fulfill this indispensable role as the "statutory bridge." However, this is by no means a mere nominal service; rather, it is a comprehensive compliance safeguard spanning from product access to full lifecycle post-market oversight, grounded in deep insight into the spirit of the regulations.

1. "Compliant Market Access" Experts in the Registration and Submission Phase

During the product access phase, our core value lies in translating complex regulatory requirements into clear, actionable pathways for our clients, ensuring they successfully navigate the NMPA review threshold.

• Precise Documentation Translation and Compliance Review

We are not merely "translators" of technical documents but "decoders" of regulatory requirements. Foreign-language technical files from overseas enterprises—such as product technical requirements, clinical evaluation reports, and risk analysis reports—must be accurately converted into Chinese submission dossiers that fully comply with NMPA standards. Leveraging our team's deep understanding of NMPA review logic, we ensure the authenticity, completeness, and regulatory compliance of every submitted document, fundamentally preventing review delays or rejections caused by documentation quality issues from the outset.

• Forward-Looking Quality System Guidance

We understand that product compliance is rooted in the manufacturing quality management system. Accordingly, we provide precise guidance to overseas enterprises to ensure that their quality management systems (e.g., ISO 13485) not only meet international standards but also seamlessly align with current Chinese regulations and standards. This forward-looking guidance helps clients solidify their compliance foundation prior to registration submission, avoiding substantial remediation costs arising from subsequent system non-conformities.

• Efficient Communication Hub and Process Facilitation

As the statutory communication interface between overseas enterprises and the NMPA, we are responsible for submitting registration applications and monitoring the review process from start to finish. Drawing on our extensive experience with review procedures and potential issues, we communicate review opinions promptly and accurately, while assisting overseas enterprises in preparing efficient and professional responses to supplementary information requests. This not only minimizes the approval cycle but also ensures smooth and professional communication, safeguarding the successful attainment of market authorization.

2. "Shared Responsibility" Partners in the Post-Market Surveillance Phase

Obtaining market approval is merely the beginning of the compliance marathon. As regulatory trends continue to evolve, the role of the local responsible entity has shifted from that of a "proxy" to a strategic partner sharing joint responsibility with the overseas registration holder. We proactively embrace this transformation and deeply appreciate our significance as the "compliance firewall" ensuring the safe and lawful sale of products in the Chinese market.

• Proactively Embracing the New Regulatory Normal of Joint and Several Liability

The latest regulatory guidance explicitly states that the local responsible entity shall bear joint and several liability with the overseas registration holder. This means that the compliance capability of the local responsible entity directly impacts the product's continued market presence. We view this not merely as a statutory obligation but as an intrinsic service standard. We fully recognize that our clients' compliance risks are our operational bottom line. Therefore, we consistently prioritize risk prevention and control in all our services, ensuring that every action withstands the most rigorous regulatory scrutiny, thereby fundamentally safeguarding our clients' long-term interests.

• Establishing a Full-Lifecycle Post-Market Surveillance System

We establish and operate a comprehensive and efficient post-market surveillance system for our clients, ensuring continuous compliance throughout the product's entire lifecycle.

01. Pharmacovigilance / Device Vigilance System: We have established professional adverse event monitoring and reporting processes to ensure timely collection, scientific analysis, and lawful reporting of all adverse events within China. We actively cooperate with regulatory authorities in safety assessments, minimizing potential risks to the greatest extent possible.

02. Product Traceability and Recall Management: We assist clients in establishing product traceability systems that comply with Chinese regulatory requirements. In the event of quality defects or safety hazards, we act as the responsible entity for controlling and eliminating such defects, promptly initiating and executing product recalls in accordance with the law to maximize patient safety and protect corporate reputation.

03. Change and Re-registration Management: Throughout the product lifecycle, whether changes involve design, manufacturing processes, or scope of application, we manage change registration or filing applications with the NMPA. Concurrently, prior to license expiration, we proactively plan and process renewal applications to ensure continuous validity of client qualifications and prevent business interruption.

• Ensuring Annual Compliance Operational Stability

We strictly fulfill the statutory obligations of the local responsible entity by submitting comprehensive annual reports to the local drug regulatory authority on time each year, providing full disclosure of product sales in China, post-market study progress, and risk management status. Additionally, we assist overseas enterprises in conducting annual quality management system self-inspections to ensure their quality systems remain continuously effective. This series of standardized, process-driven services forms the solid foundation of our "shared responsibility" commitment, ensuring our clients' products operate in full compliance across all aspects, without gaps or interruptions, in the Chinese market.