September 4th, 2017
On May 19th, 2017, Qualtech held a whole-day Global Medical Device Regulatory Conference in Taipei.
The conference began with Qualtech's Global Manager Irene Lu explaining the regulation changes in ASEAN countries and shared Qualtech's registration experiences in the local countries. Then, MedNet CEO, Mr. David Thaler, shared the responsibilities and obligations of EU representatives under the implementation of the new MDR.
In the afternoon, Qualtech and The Asia Regulatory Professional Association (ARPA) held the Global Regulatory Training Conference. We invited Taiwan Food and Drugs Administration (TFDA) Regulatory Team Leader, Wu Zheng-Ning, who talked about the latest TFDA regulatory framework and the changing trend of the regulation in the near future. Finally, the Head of RA of APAC at Baxter Healthcare, Jack Wong, who is also the founder of ARPA, introduced the global regulatory structure, the regional regulatory organizations (APEC-RHSC*, AHWP**, APRA), and the current developments of medical device.
This year, Qualtech focuses on practical experience sharing. There were many participants from the domestic medical device industry who took part in this event, and had enthusiastic discussions with the speakers. Participants shared their own regulatory experiences, as well. The conference was extended for about an hour before it could finish.
* APEC-RHSC: Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee
** AHWP: Asian Harmonization Working Party