ASEAN Nations at Varying Levels of Preparedness in Implementing Uniform Medical Device System
Malaysian Minister of Health, Datuk Seri Dr. Dzulkefly Ahmad, stated that ASEAN member states are currently at varying levels of preparedness in implementing a single submission model for medical device approval.
This system aims to harmonize the pre-market approval process for medical devices across the Southeast Asian region. With this uniform system, manufacturers would only need to make a single application to market their products in various ASEAN countries, thereby facilitating trade.
However, Dr. Dzulkefly explained that each country has different regulations and regulatory infrastructure. These differences in domestic legal systems pose a major challenge in aligning technical standards to ensure the safety and quality of medical devices are guaranteed.
Malaysia is committed to continuing cooperation with ASEAN counterparts to address these gaps. This effort is crucial to ensure that the approval process becomes more efficient and faster, which will ultimately benefit patients in the region.
In conclusion, while the goal of establishing a single submission system is positive, the implementation process requires further discussion and careful policy coordination among member states to ensure it can be executed effectively.