RAPS Webcast: Overview PMS Key Updates: China QMS/GMP Compliance per Order 739

1.0
RAC Credits
Virtual ProgramsVirtual Programs
Tuesday, 13 December 2022 (11:00 AM) - Tuesday, 13 December 2022 (12:00 PM) Eastern Time (US & Canada)

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


REGISTRATION FEES & DEADLINES

Members: Free
Non Members: $25.00


Learning Objectives

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:

  • Newly updated PMS/GMP requirements and guidelines
  • Rules and observations on overseas inspection
  • MAH qualification requirements and responsibilities
  • Requirements and penalties for AE reporting
  • IFU and Labeling compliance to avoid violations
  • The criteria of being Made-in-China and the benefits
  • Best practice and case studies

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.


Who Should Attend?

  • 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

Speakers:

Grace Palma

Grace Palma
China 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.

Maple Chen

Maple Chen

Maple Chen: 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


Cancellations

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.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.


Proof of Attendance

 A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.


Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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