To help the medical device industryprofessionals, registrants, and quality and regulatory affairs personnel quicklyunderstand global regulatory information, registration requirements, and post-market regulatory trends, we have systematically compiled resources coveringthe principal global medical device regulatory authorities, registration databases, QMS standards, adverse event and recall platforms, clinical trial registries, and medical literature search resourcesan authoritative website directoryCan be used to:
·quickly find regulations and technical guidance documents;
·search for competitor product registration information, instructions for use, and clinical data;
·obtain global adverse event, recall, andFSCAtrend updates;
·support regulatory submission, equivalent device information, QMS compliance, and literature searches for medical evaluation.
Using these resources, companies can build an efficient global regulatory tracking and evidence retrieval system, thereby improving regulatory compliance, accelerating market access, and strengthening post-market surveillance capabilities.
Category | Region/Country | Authority/Database | URL | Available Information/Use Cases | Purpose |
Regulations/Guidance | Global | IMDRF(International Medical Device Regulators Forum)— Safety Information/NCAR | https://www.imdrf.org/safety-information | Exchange of adverse event and safety information among member jurisdictions, terminology, and guidance | Can be used for cross-country vigilance trend comparisons |
Quality/System | Global | ISO 13485 Official page (Quality Management Systems) | https://www.iso.org/iso-13485-medical-devices.html | Medical devicesQMSOverview of international standards | Full standards text for compliance baselines |
Quality/System | Global | FDA QMSR Final Rule (Federal Register) | https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments | USFDA 2024YearQMSRFinal rule; refer toISO 13485 | North American supply chain quality reference |
Quality/QMS | Global | MDSAP Official website (Medical Device Single Audit Program, MDSAP) | https://www.mdsap.global/ | A single repository of quality audit information and documents covering multiple regulators | Useful reference for parallel market access and regulatory audits across multiple countries |
Regulatory/Database | United States | FDA 510(k) Database | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm | Substantial equivalence summary, indications for use, technical characteristics, etc. | Often includes key labeling information and comparative information |
Regulatory/Database | United States | FDA PMA Database | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm | IIIClass III device approval information and clinical evidence summaries | A core source of competitive intelligence for high-risk devices |
Regulatory/Database | United States | FDA De Novo Database | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm | Risk classifications and decisions for devices without predicate devices | Reference for novel device pathways and comparable-device benchmarks |
Registration/Identification | United States | AccessGUDID (public UDI search) | https://accessgudid.nlm.nih.gov/ | UDI-DI/PI, model, and label elements | Useful for model-level comparison and marketed version tracking |
Adverse Events | United States | MAUDE Database | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm | Medical device adverse event (MDR) report search | Can be used for competitor product safety profiling and signal analysis |
Recalls/Corrections | United States | FDA Recall Database | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm | From2002Device recalls in recent years/Corrective action | For same-category risk benchmarking andCAPAInput |
Companies/Products | United States | FDA Establishment registration and device listing | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/textsearch.cfm | Registered establishments and listed devices | Channel and manufacturing footprint analysis |
Full lifecycle | United States | TPLC (Total Product Life Cycle) | https://www.fda.gov/about-fda/cdrh-transparency/total-product-life-cycle-tplc-data-sources-and-disclaimers | Entry point to an integrated lifecycle view across multiple databases | Quickly locate same-category data |
Regulations | European Union | EUR‑Lex: Consolidated version of MDR 2017/745 | https://eur-lex.europa.eu/eli/reg/2017/745/2024-07-09/eng | Official text of the EU Medical Device Regulation | Authoritative source for compliance and gap analysis |
Database | European Union | EUDAMED | https://health.ec.europa.eu/medical-devices-eudamed_en | EU Devices Database (modules released gradually) | Searchable actors/UDIetc.;SSCPMade public gradually |
Clinical/public information | European Union | MDCG 2019‑9 SSCP guidance documents | https://health.ec.europa.eu/system/files/2022-03/md_mdcg_2019_9_sscp_en.pdf | High-risk/Implantable devices must be made available to the publicSSCP | Access point for competitor product safety and clinical summaries |
Notified Body | European Union | NANDO Notified Body Lookup | https://single-market-economy.ec.europa.eu/single-market/regulated-products/conformity-assessment-bodies/notifications-information-system-nando_en | EU Notified Bodies/Scope Search | Find Similar ProductsNBand Scope of Application |
Member State - Germany | Germany | BfArM Introduction to EUDAMED/EMDN | https://www.bfarm.de/EN/Medical-devices/Overview/Europe-and-EUDAMED/EUDAMED/_artikel.html | Application Information for EUDAMED and EMDN | EMDNClassification Comparison and Search Assistance |
Member State - United Kingdom | United Kingdom | MHRA PARD (Public Registration Database) | https://pard.mhra.gov.uk/ | Public Search for UK Market Device Registration | Used to verify the registered entity and product scope |
Member State - United Kingdom | United Kingdom | MHRA Device Alerts/FSN Summary | https://www.gov.uk/drug-device-alerts | UK Device Field Safety Notices and Recalls | Track CompetitorsFSN/Corrective Actions |
Member State - United Kingdom | United Kingdom | UK Approved Bodies List | https://www.gov.uk/government/publications/approved-bodies-for-medical-devices/approved-bodies-for-medical-devices | UKCA Approved Body List | Reference for Assessment Pathways and Technical Documentation Requirements |
Registration / Databases | Canada | MDALL(List of Active Medical Device Licenses) | https://health-products.canada.ca/mdall-limh/index-eng.jsp | II–IVDevice Licenses (Historical+On Sale) | Quickly locate competitor product licenses and holders |
Recalls / Alerts | Canada | Canada recalls/Safety Alerts Database | https://recalls-rappels.canada.ca/en | Cross-category recalls and safety notices | Filterable for medical device-related items |
Registration / Database | Australia | ARTG(Australian Register of Therapeutic Goods) | https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/searching-australian-register-therapeutic-goods-artg | Database of products legally supplied | Many entries include product information/Indications |
Adverse Events | Australia | DAEN(Medical Device Adverse Event Database) | https://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx | 2012 onward adverse event reports | Compare issue types and frequencies |
Recall / Correction | Australia | DRAC (Recalls / Alerts / Corrections) | https://www.tga.gov.au/safety/recalls-and-other-market-actions/database-recalls-product-alerts-and-product-corrections-drac/database-recalls-product-alerts-and-product-corrections-drac-questions-and-answers | Market action database and procedures | Useful for tracking recall strategies for similar products |
Registration / Database | Singapore | SMDR(Singapore Medical Device Register) | https://share.hsa.gov.sg/medics/PublicListing/Smdr | Public list of registered devices | Useful for comparing models, registrants, and indications |
Recall / FSCA | Singapore | HSA Risk Alerts / FSCA Notices | https://oscar.hsa.gov.sg/Publication/ahpdm/faces/FSCAPublication.jspx | Field Safety Corrective Action/Recall notices | Track local safety corrective actions |
Registration / Review | Japan | PMDA Review reports (partially in English) | https://www.pmda.go.jp/english/review-services/reviews/approved-information/devices/0003.html | Key review points for newly approved devices (selected translations) | Includes a clinical and benefit-risk summary |
GeneralDatabase | Japan | PMDA English homepage (including approved device list) | https://www.pmda.go.jp/english/ | Review, GCP/GPSP/QMS, vigilance, etc. | Overview of market access and vigilance in Japan |
Clinical Trials | Japan | clinicaltrials.jp (Japan’s official clinical trial portal) | https://www.clinicaltrials.jp/ | Japan clinical trial registration/Search | Medical device clinical research search |
Registration/Database | Mainland China | NMPA Medical device registration information search | https://www.nmpa.gov.cn/xxgk/ppkjd/ | Registration information publicly disclosed by the NMPA/Filing-related entry points | Registration certificate information searchable in Chinese |
Registration/Database | South Korea | MFDS/KIDS Medical Device Information Portal (Korean) | http://www.mfds.go.kr/eng/index.do | Device regulations, registration, and safety information (primarily Korean-language resources) | Can serve as a Korea compliance and search entry point |
Registration/Database | Brazil | ANVISA — List of Regularized Medical Devices | https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/lista-de-dispositivos-medicos-regularizados | Valid registered device list and search | Latin American market intelligence entry point |
Registration/Database | Mexico | COFEPRIS — Device Registration List | https://www.gob.mx/cofepris/documentos/registros-dispositivos-medicos | Public listing of devices with registration certificates | Spanish-language resource, including latest updates |
Registration/Database | Russia/EEU | Roszdravnadzor Medical Device Registration | https://roszdravnadzor.gov.ru/en/medproducts/registration | National registration/Eurasian Economic Union registration information | Russian and English are both used, with limited public availability |
Registration/database | Saudi Arabia | SFDA — Medical Device Listing/Notification | https://www.sfda.gov.sa/en/medical-equipment-list | Registration/licensing and safety information | Includes device reporting and vigilance channels |
Traceability/registration | Türkiye | ÜTS (Product Tracking System) | https://www.turkiye.gov.tr/saglik-bakanligi-uts | Tracking/registration for medical devices and cosmetics (account required) | Used for distribution traceability and compliance verification |
Registration/database | Taiwan, China | TFDA Medical Device License Dataset | https://data.gov.tw/en/datasets/9576 | Public licensing data (updated weekly) | Convenient for bulk download and comparison |
Registration/database | Switzerland | Swiss Agency for Therapeutic Products (Swissmedic) | https://www.swissmedic.ch/swissmedic/en/home/medical-devices.html | National registration information | Compliance information search |
Registration/database | Türkiye | Turkish Medicines and Medical Devices Agency (TMMDA) | https://www.titck.gov.tr/ | National registration information | Compliance information search |
Registration/database | Indonesia | https://infoalkes.kemkes.go.id/ | National registration information | Compliance information search | |
Registration/database | Philippines | Philippine Food and Drug Administration | https://verification.fda.gov.ph/medical_deviceslist.PHP | National registration information | Compliance information search |
Registration/database | Saudi Arabia | Saudi Food and Drug Authority (SFDA) | https://www.sfda.gov.sa/en/medical-equipment-list | National registration information | Compliance information search |
Registry/Database | United Arab Emirates | Ministry of Health and Prevention (MOHAP) | https://mohap.gov.ae/en/registered-medical-product-directory | National registration information | Compliance information retrieval |
Clinical Trials | Global | ClinicalTrials.gov | https://clinicaltrials.gov/ | Global clinical trial registrations and results (primarily pharmaceuticals, but also includes medical devices) | Used to search clinical evidence and study designs for competing products |
Clinical Trials | Global | WHO ICTRP aggregated search | https://www.who.int/tools/clinical-trials-registry-platform/the-ictrp-search-portal | Aggregates multiple countries/Regional trial registry data | Incomplete coverage |
Clinical Trials | EU/EEA | EU Clinical Trials (CTIS public site) | https://euclinicaltrials.eu/ | EU trial registrations/results after 2022-01-31 | Primarily pharmaceuticals, but medical device-related studies may also be referenced |
Clinical Trials | Australia/New Zealand | ANZCTR portal | https://www.australianclinicaltrials.gov.au/ | Australia/New Zealand trial registration and search | Supplemental regional studies |
Clinical Trials | Mainland China | Chinese Clinical Trial Registry (ChiCTR） | https://www.chictr.org.cn/ | Clinical trial registration within China | Search for medical device clinical projects |
Clinical Trials | Japan | Japanese registries such as jRCT/UMIN | https://www.clinicaltrials.jp/ | Japanese local registration | andPMDAcross-verification with review dossiers |
Literature/Evidence | Global/United States | PubMed（NLM/NCBI） | https://pubmed.ncbi.nlm.nih.gov/ | Biomedical literature and systematic review search | Free, authoritative, and supports bulk export |
Literature/Evidence | Global/European Union | PubMed | https://www.embase.com/ | International biomedical literature, including medical devices/Includes drugs and conference abstracts, with relatively comprehensive indexing | Paid access required |
Literature/Evidence | Global | Cochrane Library | https://www.cochranelibrary.com/ | Systematic reviews andRCTevidence databases | High-quality evidence appraisal and bias analysis |
Literature/Evidence | Global | Google Scholar | https://scholar.google.com/ | Interdisciplinary scholarly search (including patents/conference proceedings) | Broad coverage; quality must be appraised |
CNKI | China | CNKI | https://www.cnki.net/ | Core Chinese journals | Partially free |
Wanfang Data | China | Wanfang | https://www.wanfangdata.com.cn/ | Core Chinese journals | Partially free |
Literature/Evidence | Engineering/Standards | IEEE Xplore (Digital Health and Standards) | https://innovate.ieee.org/ieee-digital-health-standards-collection/ | Device Communications/Safety/Electrical Standards Collection | Additional engineering resources (mostly paid) |