USAID, ANSI and AdvaMed Host Regional Virtual Workshop on Good Regulatory Practices and Medical Device Regulation

USAID, ANSI, and AdvaMed have partnered to host a two-day Virtual Regional Workshop on Good Regulatory Practices and Medical Device Regulation, which took place from February 28 to March 1, 2023. The workshop was designed to provide attendees with the necessary knowledge and skills to navigate the complex and ever-changing world of medical device regulation.

Representatives from Asia Actual Philippines, Karla Justo, and Charmaine Roson, were in attendance at the virtual event. The workshop covered a wide range of topics, including the WTO TBT standards, regulatory cooperation, and coherence tools. Attendees were also educated on the benefits of recognizing foreign conformity assessment results, transparency, predictability, inclusion, consistency, and accountability.

The first day of the workshop saw discussions on specific GRPS such as public consultation, internal cooperation, and making smart decisions based on the best available science and data. Participants examined updates to the WHO Global model regulatory framework for medical devices, including IVDs, as well as fundamental ideas for WHO good reliance and the functions of the IMDRF. Indonesia shared its views on medical device regulation in accordance with International Standards and the AMDD. The importance of convergence in accelerating access to safe and effective products and improving health outcomes was also discussed.

Discussions on Reliance Models and Post-Market Surveillance

On the second day of the workshop, individual country experience with reliance models, including the common dossier template, was discussed. The panel was moderated by Seet Wing Gang, Director of Regulatory Affairs at Cook Medical, with panelists from the US Food and Drug Administration, Health Sciences Authority, Philippine FDA, and FDA Thailand. The workshop also covered the requirements for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics.

The workshop was a great opportunity for regulators and stakeholders in the medical device industry to collaborate and find ways to uphold medical device safety and standards. Discussions also centered around the implications of these guidelines and the responsibility of manufacturers. By the end of the workshop, attendees left with a deeper understanding of the medical device regulatory landscape and how to navigate it.

To learn more about the medical device registration process in the Philippines, please click here.

To learn more about the new expedited market access (Reliance Route) option in the Philippines, please click here.