Navigating China’s New Regulatory Policy: Order 739 Webinar

Overview

China’s regulations for medical technologies are undergoing a significant revision with implications for the entire product lifecycle. The new regulatory framework (Order 739 / Regulations for the Supervision and Administration of Medical Devices) went into effect on June 1, with several follow-on regulations to be issued in the coming months. This webinar will provide an in-depth overview of the key changes to product registration and post-market surveillance, helping your company to take advantage of new approval pathways and avoid possible penalties. Join us for our webinar with Sidley Austin and China Med Device on Monday, June 28 from 8:00 PM – 9:30 PM ET/Tuesday, June 29 from 8:00 AM – 9:30 AM China time for a comprehensive overview of China’s new regulatory policies. Registration for the webinar is free for AdvaMed members and government employees.

Learning objectives for attendees:

1. Grasp the key content of Order 739 and its changes across the entire product lifecycle.
2. Glean the most significant benefits for MNC manufacturers, such as NMPA’s acceptance of a self-test report or third-party test reports; the establishment of special geographic regions within China where non-approved devices can be used, etc.
3. Discover how clinical evidence can be leveraged in more versatile ways to support clinical evaluation.
4. Become familiar with fast-track approval pathways for cutting-edge innovations and products intended for emergency use.
5. Learn how to avoid penalties as post-market monitoring will become more stringent.

Presented by:

Speakers

Ralph F. Ives, Executive Vice President of Global Strategy and Analysis, AdvaMed

Ralph F. Ives is Executive Vice President of Global Strategy and Analysis, from August 2004 to present.  Ives is responsible for the Association’s efforts to provide adequate reimbursement, appropriate regulations, and open market access for medical technology products.

Ives was Assistant U.S. Trade Representative for Asia-Pacific and APEC Affairs, and Assistant U.S. Trade Representative for Pharmaceutical Policy in the Executive Office of the President.  Ives previously served as Deputy Assistant U.S. Trade Representative for Latin America (1993-96), Europe and the Mediterranean (1996-99), and Agriculture (1999-2000), and in various Director-level positions at USTR. From 1974 until joining USTR in 1988, Ives was an international economist in various positions in the Department of Commerce. From 1971-74, Ives was an officer in the U.S. Air Force.

Grace Fu Palma, CEO, China Med Device, LLC

Grace is the CEO of China Med Device, LLC (www.ChinaMedDevice.com) with offices in Beijing and Boston provides turnkey solution for regulatory and medical affairs (RA, CRO, QA, PMS etc.) for western medical device/IVD companies to enter China, specifically in regulatory strategy, registration, China local type testing, clinical evaluation report (CER), full service (CRO) with clinical trial design as well as onsite monitoring, regulatory compliance, PMS and related services. China Med Device offers U.S. manufacturers both a local point of contact and China-based technical expertise, with experience with 1,000+ NMPA (CFDA) certificates and 250+ companies.

Grace has 20+ years of experience driving global business strategy, commercialization, partnerships, and global/China operations for both large multinationals (Hewlett Packard Medical, Agilent, Philips Healthcare) and startup (Teratech) companies. She is a regular speaker at key national and local Medtech meetings (RAPS, AdvaMed, FDAnews etc) and writer for multiple journals on NMPA (CFDA) regulatory and clinical affairs.

Grace grew up in Beijing, China, received her Joint BA at Peking University, China, and an MBA from Yale University, USA. Grace is the founder of Chinese American Heart Association (www.CnAHA.org) with 500+ cardiovascular clinicians and researchers with Chinese origin.

Chen Yang, Senior Counsel, M&A, Anitrust / Competition, Food, Drug and Medical Device Regulatory, Sidley Austin LLP

Chen Yang is senior counsel of Sidley Austin LLP and the head of the Firm’s China Life Sciences Practice. Since joining private practice in 1994, Chen has been representing international companies on their investment projects and acquisition efforts in various Chinese industries, and also assisted the P.R.C. government agencies with respect to U.S. litigations.

Chen started the Firm’s China Life Sciences Practice in 2007 and since then has been routinely advising international pharmaceutical, medical device, and other life sciences companies in connection with market entrance, product localization, marketing and promotional activities, product recalls, clinical trials, FCPA/anti-bribery and other industry-specific regulatory, compliance and enforcement issues. She has also represented world-renowned multinational pharmaceutical, medical device and animal health companies in China-related joint ventures, merger and acquisitions, and licensing transactions.

Chen has been well-recognized for her knowledge and expertise in the China life sciences sector. She was given the Life Sciences “All-Star” award by The Asian Lawyer” and has been ranked Band 1 for China Life Sciences (International Firms) In the Chambers Asia-Pacific rankings from 2013 to 2021.

Pricing

• AdvaMed Member Registration: Free
• AdvaMed Accel Member Registration: Free
• Government Registration: Free
• Non-Member Registration: $100.00

Webinar Recording