China is one of the most attractive markets for medical device manufacturers worldwide and has grown to be the second largest in Asia (after Japan). However, given recent problems with heparin, di-ethylene glycol and melamine poisoning, quality issues have become paramount. Add to the that the challenge of navigating the Chinese regulatory system and medical device manufacturers face a daunting task, to put it mildly.
It's no wonder then that our audio conference Navigating China's Medical Device Regulations is drawing such huge interest. Chang-Hong Whitney will provide first-hand insights and guidance, drawing upon the experience and knowledge gleaned from daily dealings with SFDA officials and through managing numerous registration projects in China:
- Overview of Chinese regulations for medical devices
- Recent changes to the regulatory requirements
- Requirements for getting medical products approved for the Chinese market
- Time and costs for getting regulatory approval of medical products in China
- Regulatory issues to watch for and obstacles while seeking approval in China
If you would like to learn more about China, take a look at the following:
- China center for medical device standards is unveiled
- Securing regulatory approval for IVDs in China
- Language fact: Chinese
ForeignExchange Translations provides specialized medical translation services to medical device companies - in Chinese and dozens of other languages. Contact us to find out why our clients rave about us!