China’s National Medical Products Administration (NMPA) continues to roll out new and updated guidance and technical standards documents for medical devices and in vitro diagnostics (IVDs). In August 2024, the NMPA released historic first law governing medical devices “Law of the People’s Republic of China on the Administration of Medical Devices (Draft for Public Comment)” and showed China intends to increase its medical device development and quality level.
In this session, we will explore the significant changes proposed in this new medical device law and their impact on foreign companies entering the market. We will also explain the recent key regulatory and clinical factors to shorten time to market, including how clinical evidence can be leveraged in more versatile ways to minimize or avoid in-China clinical trials.
We will draw on deep industry experience about how utilizing "green-channel" pathways enables additional flexibility for in-market sales performance. Alternative pathways for market entry will be strategized and discussed, especially recent developments in China’s Greater Bay Area (GBA) and Beijing urgent use policy.
In the end, we will provide updates in Made-in-China policy and China GSP that impacts sales operations especially for foreign manufacturers operations in China. Best practices and regulatory requirements relating to maintaining registrations and compliance such as overseas NMPA audits will also be presented with examples, in light of increasing post-market scrutiny and activity by NMPA.
Registration Fees & Deadlines
Free
Learning Objectives
Upon completion of this workshop, participants should be able to:
- Explore and explain the recent key regulatory and clinical factors to shorten time to market
- Discuss the best practices and regulatory requirements relating to maintaining registrations and compliance
- Provide an overview of China's regulatory framework and the latest updates
Who Should Attend?
Recently, there have been significant changes in the requirements around human factors for medical devices. This workshop will provide practical guidance and information for:
- Clinical affairs professionals
- Managers in the life sciences industry
- Regulatory affairs professionals
- Quality affairs professionals
- Medical affairs professionals
- R&D managers
- Compliance managers
- Operations managers
- Marketing and business executives
- Chief financial and commercial managers
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Agenda
|
Time
|
Topic
|
|
11:00 - 11:15 AM
|
Overview of significant changes proposed in new medical device law and their impacts, key regulations, guidelines, and standards
|
|
11:15 – 11:30 AM
|
Key updates for China clinical evaluation: overseas clinical data, clinical trials, CER and how clinical evidence can be leveraged in more versatile ways to minimize or avoid in-China clinical trials
|
|
11:30 – 11:50 AM
|
Other key updates include special policies for the use of non-approved devices within the Greater Bay Area, Beijing and Hainan. “Made-in-China” measures to shorten regulatory approval timelines, GSP/QMS etc.
|
|
11:50 - 12:20 PM
|
Key opinion roundtable with policy and regulatory executives in 2024 and 2025
|
|
12:20 - 12:30 PM
|
Q&A
|
Speakers
Grace F. Palma
MBA, Principal, China Med Device
Grace Fu Palma is the principal of China Med Device, part of the global market access platform, Accel Groups. She is a seasoned bilingual and bicultural MedTech executive, specializing in China and US regulatory and commercialization services. She has 30 years of experience driving global and China business strategy, regulatory, clinical evaluation and trials, commercialization, partnerships, for both large multinationals and startup companies. She started China Med Device (CMD) in 2011. She has been personally involved in launching hundreds of medical devices in the US and China market, and is a regular invited speaker on China and US regulatory, clinical evaluation and trials, and market access subjects at key national and local MedTech meetings such as AdvaMed and RAPS, FDA News etc. She also contributes to multiple industry and regulatory journals.
Qianqian Zhu
Director China/HK RAQA, Intuitive Surgical, Inc.
Qianqian is the Director of China/HK RA/QA at Intuitive Surgical, Inc., serving as a pivotal link between Intuitive’s RAQA department and the IntuFosun RAQA team — a joint venture between Intuitive and Fosun. She plays a crucial role in developing localization strategies, negotiating support, and executing plans for in-country manufacturing transfer, regulatory approvals, and registrations. Prior to her current role, she excelled as the Director of International Regulatory Affairs at Immucor, Inc., managing international regulatory requirements, including product registration, importation compliance, and post-market vigilance.
Vicky Tao
Sr. Director, Quality, Regulatory, and Clinical Affairs of Revvity (Shanghai) Co. Ltd. (former PerkinElmer)
Vicky Tao has more than 25 years of regulatory experience in the pharmaceutical and medical device industries. Her experience includes management of regulatory submissions, clinical studies, post-market surveillance, and QMS for both imported and domestic drugs, medical devices, and IVDs. She has Involved in project management and led corporate agile transformation. Under her leadership, regulatory approvals were granted for several first-in-class products, including NCE, biologics and IVDs. She participated the pilot programs of real-world-evidence (RWE) application for innovative product in Hainan Boao and the advanced product for urgent clinical need in the Greater Bay area.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org