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This
webcast CD provides an overview of the medical device
regulations of the Chinese State Food and Drug Administration
(SFDA) as well as discusses the most recent regulatory issues
(including product registration). This China presentation has
62 PowerPoint slides. The speaker is PBM's partner in China.
Click
here to see a sample
page of our webcast presentation.
The
following topics are covered in this webcast:
- Product
registration and timeline of review process
- Reimbursement and
pricing
- Approval
procedures for conducting clinical trials in China
- Requirements
for product inserts, labeling and packaging
- Dossier preparation
and key documents for submissions
- Classification
system of medical devices
- Good
Manufacturing Practice (GMP)
- Good
Clinical Practice (GCP) Good Labor Practice (GLP) ISO
13485
- Post-marketing
surveillance and quality control
- Other
new regulations
This
webcast is designed for medical device professionals in regulatory
affairs, business development, international sales and marketing,
and anyone who wants to be current on a number of new Chinese regulatory
issues.
Our speaker is from China and has over twenty
years of experience in Chinese regulatory affairs
Click here to purchase a CD which includes
the audio and PowerPoint presentation.
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