The rise of AI in diagnostics is revolutionizing healthcare, but for MedTech innovators, it presents a complex regulatory challenge. In the key ASEAN market of Malaysia, the risk classification of your predictive software is the single most important factor determining your path to market, influencing everything from cost and timelines to the required depth of clinical data. Get it wrong, and you face significant delays and financial loss. Consider this scenario. A startup develops a groundbreaking AI algorithm to predict sepsis risk in ICU patients. They believe it’s a decision-support tool, classifying it as moderate-risk Class B. However, the Malaysian Medical Device Authority (MDA) interprets its function as directly guiding critical treatment decisions, reclassifying it as high-risk Class C. This single change adds a year to their timeline and requires a new round of clinical studies they hadn't budgeted for, jeopardizing their entire market entry plan. This episode dissects the nuances to prevent such a costly mistake. Key Questions Answered in This Episode: - What are the two critical questions the Malaysian MDA asks when classifying your medical software? - How can a minor change in your software's "intended use" statement shift its risk class from B to C? - How does the seriousness of a disease, like cancer versus allergies, directly impact your software's regulatory pathway in Malaysia? - What are the major documentation and clinical evidence differences between a Class B and Class C software submission? - What are the most common pitfalls that lead to the misclassification of predictive AI software in ASEAN markets? - How is Malaysia aligning its Software as a Medical Device (SaMD) regulations with global IMDRF standards? - What specific challenges do predictive algorithms face during the regulatory review process compared to other medical software? Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. To navigate the complexities of SaMD classification and accelerate your entry into ASEAN markets, contact Pure Global at [email protected] or visit us at https://pureglobal.com/.