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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
China’s medtech market has enjoyed double-digit growth in the past decade, but there are challenges for post market sustainability especially for legacy products, made-China policy, and MAH post State Order 739. Whether the devices sold in China are from overseas imports or domestically made, they must be in compliance with China GMP; otherwise there are increased penalties. Since the implementation of State Order 739: “Regulations on Supervision and Administration of Medical Devices” in June 2021, a series of updated requirements in GMP and post market supervision were introduced such as the newly released “Guideline on Inspection of Quality Management System for Medical Device Registration” on October 10, 2022
Non Members: $25.00
During this webcast we will present the overview of China PMS/GMP requirements along with major updates on PMS/GMP regulation and guidelines. After this 60-minute session you will have a practical understanding of the following:
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.
Grace PalmaChina Med Device
Grace Fu Palma: a Sino-US MedTech veteran, founded China Med Device (www.ChinaMedDevice.com) to provide turn-key solutions for western medical device/IVD/combination products’ companies to enter China with regulation and commercialization services. Grace has 20+ years of experience driving global product strategy, commercialization, partnerships, and China operations for both large multinationals and startup companies. She has held a variety of management positions in marketing and operations at multinationals and start-ups. Grace founded the Chinese American Heart Association in 2005. She is a frequent trainer and speaker at national regulatory meetings as well as a column contributor for US regulatory news and journals.
25+ years of experience in QMS setup and operation of medical device and electronics industries
Audited 100+ Manufacturers and Completed follow-up actions for their ISO 9000 certification and compliance
Specialize in GMP, PMS and remediation gap analysis between China NMPA and US FDA
Responsible for MAH, Order 104, NHSA, UDI, LA transfer etc.
BS – China Pharmaceutical University; MBA – Sun Yat-sen University; Medical Device RQA - Temple University
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
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A certificate of attendance can be
downloaded from the RAPS Learning Portal following the event.
For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-helpFor account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org.