APACMed - Regulatory Heatmap

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APACMed Regulatory Heatmap

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Summary
Country

Components

Key Issues
Cross Product Lifecycle
Halal UDI – Implementation of UDI in Different Stages Local Protection (incl. mandatory local standards) MDR Real World Evidence (RWE) Emergency Authorization Mechanism (EUA) Reliance/Recognition Lab Developed Tests (LDT) Research Use Only Products (RUO) IVDR
Pre-Market
MD Classification IVD Classification Labeling Grouping Pre-Submission Consultation Good Review Practice (GRP) Local Language Labeling
Clinical/Performance..
Clinical Evaluation Local Testing Acceptance of Overseas Clinical Performance Evaluation
QMS
Acceptance of ISO Certificate Software QMS Remote Audit/Inspection
Distribution
Advertisement/Promotion Regulations Parallel Import 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 Data Governance Privacy Law - Important Area For Cloud Solutions Home-Based/Remote Care Software in/As Medical Device Regulation (With AI/ML) Next Generation Sequencing

*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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