If you would like to join our Qualtech Webinar on the topic of the “EU MDR”, please access the webinar by using the following link and passcode:
Zoom Webinar Link: https://us02web.zoom.us/j/82820233612?pwd=MEhBeGYvY3ZhZjljSjhrNGpDL09XQT09
Webinar ID: 828 2023 3612
Would you like to enter various Asian markets in one step? Do you want to learn more about the regulation differences among the different ASEAN countries? And are you aware that the ASEAN Medical Device Directive (AMDD) will provide you with a chance to enter multiple ASEAN countries via an abridged evaluation route?
If you would like to know more about these aspects and many more important regulatory information for the ASEAN markets, you may join Qualtech’s ASEAN Regulation Update Webinar on 28 April 2023 (Friday) at 16:00 p.m. – 17:30 p.m. (GMT+8).
Time Reference for Different Time Zone:
- 4:00pm to 5.30pm local Taiwan Time (GMT+8)
- 5:00pm to 6.30pm local Japan Time (GMT+9)
- 10:00am to 11.30am (Central European Summer Time - CEST) (UTC +2)
ASEAN Regulation Updates and Current Status
(*Presentation order may change)
• Indonesia (10 min)
• Malaysia (10 min)
• The Philippines (10 min)
• Singapore (10 min)
• Thailand (10 min)
• Vietnam (10 min)
• Q&A Session (10~30 min)
What to know about the ASEAN Regulation:
In order to reduce technical barriers for medical devices to enter the various ASEAN markets, the ASEAN Medical Device Directive (AMDD) was signed by ten Member States in 2015. Thereafter, all 10 countries have started to transition to AMDD. This harmonization helps manufacturers to obtain market access in multiple countries simultaneously, while it also increases the likelihood that safe and effective devices are quickly accessible to patients in the region. As of now, a number of counties is in the full implementation of the harmonized regulation, other ASEAN nations are still on the way to thoroughly implement the AMDD. Thus, for those interested in entering the ASEAN markets, it is important to be updated on the current status of the transition. Qualtech’s free webinar may therefore be an ideal opportunity to obtain the information needed for making a wise business decision.
To register for our webinar, please click here and complete the sign-up form before the space runs out.
A confirmation email will be sent to you after filling in the form. Please contact us, if you have not received a confirmation email with the Webinar link by the third or the beginning of the fourth week of April.
Furthermore, do not hesitate to reach out to us at any time if you have questions, comments, or concerns regarding the event.
We look forward to seeing you online.