Background:

Medical devices bear a direct connection to human health and safety. Compliance stands as the essential prerequisite for products to enter the market and the fundamental criterion for enterprises to manage risks and attain sustainable development. Currently, the global medical device regulatory landscape is becoming increasingly stringent, with the FDA’s rigorous oversight becoming the norm and domestic regulations continuously evolving. Whether it involves product registration, quality control, testing and certification, or system development, companies are confronted with heightened compliance demands. The cost of non-compliance has risen significantly, and cases of severe market setbacks due to compliance failures serve as a stark warning to the industry. To assist medical device companies in addressing compliance challenges, accelerating time-to-market, and surmounting obstacles throughout the entire compliance and commercialization process, the 7th Regulatory Seminar is held. Focusing on core compliance needs, it brings together top-tier industry service providers to establish a targeted matchmaking platform, empowering companies to achieve efficient product compliance and market entry.

Purpose:

• Discuss the key regulations and response strategies in the medical device industry
• Seek ways to accelerate the medical device products launch
• Jointly promote the innovation and development of medical device products
• Combine with the concurrent exhibitions to provide a platform for medical device regulatory practitioners to communicate and interact with each other

Participants:

• Medical device manufacturers: heads of the departments of registration, quality, compliance, medical, and R&D, as well as project/company leaders
• Domestic and international providers engaged in medical device regulatory consulting, testing, certification, inspection, clinical trials, etc.
• Medical device regulatory agencies and research organizations