Newsletter â HK and Asia Regulatory - BSI America
Newsletter â HK and Asia Regulatory - BSI America
Newsletter â HK and Asia Regulatory - BSI America
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Convener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comSummary of Procedures• Site Master File (clause 2.2.2)– Introduction to GDPMDS– Quality Management system– Resource management– Storage <strong>and</strong> stock h<strong>and</strong>ling– Traceability– Product Complaint– Field Safety Corrective Action– Returns– Disposal– Counterfeit Devices– Internal Audits– Management Review– Outsourced ActivitiesPlease also note there are 12 product categories for GDPMDSapplication:1. Active implantable devices2. Anesthetic <strong>and</strong> respiratory devices3. Dental devices4. Electro mechanical medical devices5. Hospital Hardware6. In vitro diagnostic Devices7. Non-active implantable devices8. Ophthalmic <strong>and</strong> optical devices9. Reusable instruments10. Single-use devices11. Technical aids for disabled persons12. Diagnostic <strong>and</strong> therapeutic radiation devicesFor further clarification or assistance required for GDPMDS, you may like to contactCarol Sim, at carol.sim@bsigroup.com or +65 9749 2832.
Change language