How to register your Medical Device in the ASEAN region?
The focused region is the region that agreed to follow the ASEAN regulation. ASEAN means the Association of South East Asia Nations.
In this episode of the podcast, Michael Wetherington will help us to have a better understanding of how to register your products in this region.
You will see that there are some differences with the fact that even if all countries are following the same directive, there can be still some differences. And also that having a Partner in the region can help you save a lot of time and money.
Fortunately, MedicalReg,com can help you so don’t hesitate to contact Michael Wetherington if you need any support. As said in this episode he proposes his service to help manufacturers that try to reach this region.
Don’t forget to check the links below to understand more about this directive.
Who is Michael Wetherington?
Michael Wetherington is the Founder of MedicalRegs.com. MedicalRegs.com helps MedTech startups design devices with the applicable requirements in mind. They go further by providing regulatory services for the EU, US, Canada, and ASEAN markets.
His background encompasses medical device R&D, accredited testing lab, and Notified Body experience. He is also a mentor at Elemed’s Mentoring Academy. And, when time permits, he likes to sing, play the drums, and the guitar.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
Finally, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
- Michael Wetherington Linkedin Profile: https://www.linkedin.com/in/medicalregsdotcom/
- MedicalRegs.com website: https://medicalregs.com
- ASEAN Directive: https://asean.org/storage/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
- Countries: https://asean.org/asean/asean-member-states/
- Best practice for Device testing with Michael Wetherington: https://podcast.easymedicaldevice.com/89/