APACMed - Regulatory Heatmap

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APACMed Regulatory Heatmap

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Summary
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*The heatmap depicts issues in the countries wherein, 1 denotes the highest no. of issues on a scale of 1-10.

Key Issues

Cross Product Lifecycle UDI – Implementation of UDI in different stages , Local protection (incl. mandatory local standards) , MDR , Reliance/recognition , IVDR / Pre-Market MD Classification , Labeling , Grouping , Pre submission consultation , Good review practice (GRP) , Local language labeling / Clinical/Performance evaluation/testing Clinical evaluation , Local testing , Acceptance of overseas clinical performance evaluation / QMS Acceptance of ISO certificate , Software QMS / Distribution Advertisement/Promotion regulations , Customs control / Post Market Post market surveillance , Re-registration/license renewal , Change Management / Innovation/Digital Health Green channel/abridged review/expedited for innovative technologies , Cybersecurity , Software as medical device regulation (with no AI/ML)(incl. qualification, classification, separate registration for multiple functions) , Pre-determined changes for SaMD

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