MDA 2026 Guidance on Import and Supply of Unregistered Medical Devices under Special Access Exemption

FDA’s 2026 PPI guidance encourages voluntary collection of patient preference information across the total product life cycle. Devices with direct patient interfaces, subjective outcomes, or high risks benefit most. PPI supports premarket submissions, labeling, and post-market evaluation. Guidance aligns with EU MDR/IVDR PMCF/PMPF principles, helping assess patient risk tolerance and benefit-risk trade-offs. Manufacturers should collect scientifically valid PPI to inform regulatory decision-making and enhance patient-centered device development.

EU Commission Rev.2 Q&A 2026 clarifies obligations for manufacturers and authorized representatives to notify authorities about supply interruptions or discontinuations of medical devices and IVDs. Key updates include expanded guidance on assessment indicators (Q9.2) and a decision tree tool to support risk assessment. Staying compliant with Article 10a MDR/IVDR ensures uninterrupted market access and patient safety.

The MDA’s 2026 Third Edition guidance clarifies the import and supply of unregistered medical devices under Special Access Exemption (SAE). Key updates include detailed eligibility, Medcast application process, labelling, record-keeping, and post-handling requirements. The guidance ensures timely access to critical devices while maintaining compliance with Malaysian regulations and patient safety. All healthcare providers and industry stakeholders must obtain SAE approval before importing or supplying unregistered devices.

The MDA’s 2026 Second Edition guidance clarifies the definition of medical devices, including accessories, components, and spare parts. It helps manufacturers, importers, and healthcare providers identify which items require registration under the Medical Device Act 2012 (Act 737) and associated regulations. Compliance with this guidance ensures proper classification, regulatory adherence, and smoother market access in Malaysia.