25 February 2016
5:30-8:30 pm
Babson College Executive Conference Center
Babson Park, MA
Come snack and learn with others in your local regulatory community!
The RAPS Boston Chapter invites you to join us for an opportunity to meet local colleagues and learn more about medical device regulations in China.
The China Food and Drug Administration (CFDA) released a series of new medical device regulations in October 2014, which reformulated some of the key requirements for medical device registrations. After a few months of implementation, some glitches in the new regulation are yet to be ironed out. Topics to be covered during this presentation include:
- Key points in the new regulations
- Current implementation by CFDA
- Potential issues facing imported devices
Chang-Hong Whitney, RAC, MBA, a successful China business consultant for Fortune 500 companies with more than 10 years experience in the Chinese medical device industry, will present “stories” from her daily dealing with CFDA, the first-hand experience with the new regulations and regulators, as well as ways to handle challenges that go along with operating in that market. This will be a highly interactive presentation and attendee participation is strongly encouraged.
A dinner buffet will be available and attendees can claim two (2) recertification points.
Speaker:
Chang-Hong Whitney, RAC, MBA, president, Whitney Consulting Ltd
Local contact: Sue Hamann, MA, RAC, RAPS Boston Chapter Chair
RAPS contact: Wesley Carr