Global Medical Device Registration and Market Access
GHWP member states, emerging markets and international regulatory strategy
Compliance connects the world, expertise creates value.
GHWP member state focusCountry registration pathwaysTechnical documentation supportPost-market compliance tracking
Global Focus
Built for medical device manufacturers entering international markets
AIMEILI helps manufacturers understand registration pathways, documentation requirements, local representative duties and post-market obligations across GHWP member states and other key markets.
Country Registration
GLOBAL COUNTRY DATABASECountry RegistrationBahrain
English reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read more Country RegistrationBruneiEnglish reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read more Country RegistrationCambodiaEnglish reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read more Country RegistrationEgyptEnglish reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read more Country RegistrationEthiopiaEnglish reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read more Country RegistrationGhanaEnglish reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read more Country RegistrationHong KongEnglish reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read more Country RegistrationIndiaEnglish reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read moreLatest Regulatory Updates
NEWS & UPDATESRegulatory Update2026 11 Fda 510 K
English reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read more Regulatory Update2026 11 Fda B BraunEnglish reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read more Regulatory Update2026 11 Ivd 1 2English reference page for medical device international registration, regulatory strategy, technical documentation, local representative requirements and post-market compliance.
Read more Regulatory UpdateFDA Publicizes Philips Azurion Recall in October 2026: Undocumented Solid-State Drives Affected 9 Models and 4,304 UnitsThe U.S. FDA Device Recall database has publicized a Philips Azurion correction involving 9 models and 4,304 units because some system computers may contain solid-state drives not documented in the Medical Device File. Philips Medical Systems Nederland B.V. issued an urgent customer letter on October 6, 2026; the FDA r
Read more Regulatory UpdateFDA Early Alert: ButterflyBVM Bag-Valve-Mask Corrugated Bags May Develop Holes; 31 Lots Split into Removal and Correction ActionsFDA/CDRH updated an Early Alert on November 3, 2026, for certain ButterflyBVM disposable bag-valve-mask resuscitators: 9 lots must be removed and 22 lots may remain in use with a pre-use device check. No serious injury or death had been reported as of November 2, 2026.
Read more Regulatory Update28 November 2026 EUDAMED deadline: legacy devices and models still placed on the EU market must be registeredThe EUDAMED UDI/Device module becomes mandatory on 28 May 2026, with 28 November 2026 as the registration deadline for existing devices whose first unit was placed before mandatory use and whose units are still being placed. AIMEILI outlines scope, exemptions and business impact.
Read moreFAQ Knowledge Base
RECENT FAQ医用敷料海外注册How Should Multiple Models of Medical Dressings Be Grouped for Overseas Registration?
A practical FAQ on grouping multiple medical dressing models into one overseas registration unit, covering classification, risk level, registration pa
海外注册与质量体系合规How to Handle Inconsistent Quality System Certificates for Overseas Registration of Disinfection and Sterilization EquipmentA practical guide for global medical device stakeholders. It explains how to assess regulatory classification and registration pathway, anchor the evi
海外注册风险管理What Are the Requirements for Risk Management Documentation for Overseas Registration of Medical Dressings?A professional guide to preparing ISO 14971-based risk management documentation for overseas registration of medical dressings, covering classificatio
海外注册与合规How to Prepare Performance Verification Documentation for Overseas Registration of Sterilization and Disinfection EquipmentLearn the essential steps, regulatory considerations, and common pitfalls for preparing performance verification documentation for overseas registrati
海外注册变更管理When Should Post-Market Change Applications Be Filed for Overseas Registration of Medical Dressings?This article explains the regulatory triggers and submission timelines for post-market changes to medical dressings registered overseas. It covers cla
海外注册周期管理Why Are Overseas Registration Timelines for Disinfection and Sterilization Equipment Extended?This FAQ explains why overseas registration timelines for disinfection and sterilization equipment are often extended, covering classification, techni