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Home » Store » Device Products » China Medical Device Regulatory Changes - Webinar CD/Transcript

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Audio CD/Transcript - Jan. 31, 2017

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China Medical Device Regulatory Changes - Webinar CD/Transcript

$287.00
Device Products

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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.

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