We are very grateful to announce that there was another amazing opportunity with our long-standing partner to collaborate. On September 29th, 2022, OMETA (the Overseas Medical Equipment Technical Assistants) and Qualtech hosted a webinar to summarize drastic changes happening in the medical device regulation industry. In this webinar, Qualtech’s Japan office and Taipei office took part in introducing regulatory updates in Asia.

The following are the major related topics delivered by Qualtech.

  1. 1. Taiwan FDA – QSD essential mode, UDI, GDP
  2. 2. China NMPA – Changes of regulations
  3. 3. Philippines FDA – Upcoming IVD new regulations
  4. 4. Vietnam MoH – End of transition period?
  5. 5. Thailand FDA – Change notification and expedited route

We are truly thankful for OMETA, who delivered updates on UKCA (UK Conformity Assessed), and for another amazing partner mkDuo, who provided the current status of PMS/GVP and related regulatory difference between Japan and other countries to make the webinar a great success.

For further inquiries about the regulatory updates in the Pacific Asia-Pacific, please kindly contact us under the following email address: Christian.s@qualtechs.com