On April 16th Qualtech hold a webinar, where it introduced its audience to an overview of medical device regulations updates in three ASEAN countries. Our experts - Qualtech regional leaders from Thailand, Malaysia, and the Philippines - prepared comprehensive reports regarding all changes.

The online event covered the following topics:

  1. Thailand has implemented a new medical devices registration procedure based on ASEAN Harmonization risk classification. In addition to the overview, the Qualtech team presented an up-to-date registration timeframe, change to notification, and license renewal process.

  1. Malaysian update concerned re-registration of registered medical devices and implementation of labeling requirements. Our audience had a chance to go through the new reregistration requirements organized in flowcharts, and to see the steps and documents needed for this procedure.

  1. The Philippines expert made an overview of FDA-Circular-No.2021-002- Full Implementation of Administrative Order No. 2018-0002. He began with comparing Administrative Order 2018-0002 to FDA Circular 2021-002. Then elaborated on CMDN for Class B-D Non-registrable products, where touched upon the validity, requirements, transition period, workflow for products with and without PFDA certificates issues.

At the end of the webinar, all the participants were able to raise their questions and get exhaustive answers from Qualtech’s regulatory team. 

If you are interested in ASEAN regulatory updates or any other Asian country, please feel free to contact us at your earliest convenience: artem@qualtechs.com. Qualtech is always ready to assist its clients, and we look forward to seeing you during our upcoming webinars.