Medical Device Regulatory Affairs Training

Comprehensive Training for Successful Market Entry

The booming medical device and IVD markets in Southeast Asia require updated regulatory requirements for user safety. Despite adopting the ASEAN Medical Device Directives (AMDD), the region’s diverse markets pose challenges for navigating regulatory procedures.

At Presage Elite, we are proud to offer a comprehensive series of on-demand medical device regulatory affairs training courses. Our courses are designed to equip learners with a profound understanding of the intricate medical device regulatory pathways in Southeast Asia. By participating in these courses, learners gain valuable insights that enable them to adeptly navigate the intricacies of medical device registration processes in each country. Moreover, learners will be empowered to steer clear of common pitfalls, thus ensuring a successful implementation of their medical device regulatory strategy.

Mandatory Problem Reporting

Our medical device regulatory affairs training courses are crafted by our team of Regulatory Affairs Specialists, who operate within their respective countries to facilitate the registration of medical devices and IVDs for manufacturers globally.


They possess extensive experience in handling renewals, change of ownership, and license transfers, and engage in daily interactions with local regulatory authorities.


The courses encompass a comprehensive curriculum such as:

1. Market Overview
2. Authority’s Background
3. Legislative Framework
4. Registration Information (Classification, Grouping, Process Flow, List of Documents)
5. Required Licenses or Certificates
6. Registration Fee and Timeline
7. Renewal of Medical Devices
8. Change Notification
9. Change of Ownership/ License Transfer

Major Pluses

Our on-demand courses offer learners complete flexibility in terms of when, where, and how they undertake their medical device regulatory affairs training. Participants can choose courses specific to their country of interest or opt for the complete package, all at a fraction of the cost of traditional face-to-face training.


The key benefits of our courses include:

1. A consolidated and comprehensive solution to fulfill all medical device regulatory affairs training requirements, accessible through an intuitive and user-friendly learning platform.

2. Simultaneous or independent participation for staff members from multiple departments and site locations, whether locally, nationally, or internationally.

3. Measurable and quantifiable results with an online quiz at the end of each course, allowing learners to test their knowledge effectively.

4. Practical, interactive, and up-to-date professional development ensuring learners gain practical insights.

5. A certificate awarded upon successful completion of the quiz, recognizing the learner’s achievement.

6. One year’s access to the course content online, with the option to download materials for future reference.

7. An online account, providing a detailed listing of registration history and payments for enhanced convenience.


Take the next step towards achieving remarkable success in the medical device industry.

Our expert consulting services are tailored to propel your company forward. Streamline your regulatory processes, enhance product development, and ensure compliance with ease.