China Medical Device Regulatory Changes - Webinar CD/Transcript

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China Medical Device Regulatory Changes

If you’re doing business in China or want to — you need to know the latest device regulatory requirements for manufacturing devices there.

Grace Fu Palma — founder of China Med Device — knows them. She has over 20 years of medical device industry experience in China and the United States, working with multi-national corporations and start-ups. Originally from Beijing, she capitalizes on a cross-cultural mindset gained from her experiences in both China and the U.S.

During this session Grace will discuss recent developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement. These developments can affect all medical device companies, whether your manufacturing facilities are in China or abroad.

After this 90-minute session you will have a practical understanding of the following compliance issues:

  • Implementation of the new GMPs, including the procedural rules for inspections, preparation, communicating with investigators, resolving issues, and potential penalties.
  • Transfer of manufacturing sites and amendment of manufacturing and device licenses.
  • Policies and rules on contract manufacturing for medical devices.
  • Handling self-inspections and evaluations of past compliance, including recent examples.

Order today and be up-to-date on China’s medical device regulations.

  • Consultants/service providers
  • Engineering and design controls teams
  • Compliance officers
  • Executive management
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • QA/QC personnel
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff
  • Attorneys/legal department

Grace Fu Palma, Founder, China Med Device
Grace Fu Palma founded China Med Device in 2012 in Boston, Massachusetts. Since its founding, China Med Device has helped many U.S. medtech companies expand into China. Grace has over 20 years of medical device industry experience including driving product strategy, positioning, launches, sales channels development, partnership and JV establishment for both large multinationals and start-up companies. She is bilingual (English/Chinese) with a proven leadership ability to develop business alliances and grow sales in both emerging and mature markets.