UAE: device marketing authorisation
Apply through EDE’s medical-device marketing-authorisation service.
Source page checked: 3 October 2026. Check the current linked requirements.
AUPAM / MEDICAL DEVICES & SUPPLIES
A reference desk for medical technology.
Official sources, research methods and scientific databases, organised by the work you need to do. Search, save a reading list and export references.
58curated sources
12learning modules
8worksheets
Egypt: device regulatory guidelines
Select the applicable registration and import-approval guidance separately.
Source page checked: 3 October 2026. Check the current linked requirements.
Oman: medical-device registration
Use the Drug Safety Center’s medical-device registration service.
Source page checked: 3 October 2026. Check the current linked requirements.
FDA device regulation
Start with intended use, classification and the applicable US pathway.
Living source: check the version of the individual document.
Original publisher’s resource
Quality Management System Regulation
US QMSR, effective 2 February 2026; incorporates ISO 13485:2016 by reference.
Living source: check the version of the individual document.
Original publisher’s resource
FDA medical device databases
Classification, 510(k), PMA, De Novo, identifiers and safety-report databases.
Living source: check the version of the individual document.
Original publisher’s resource
Device recalls & early alerts
Open the original action and affected-product details.
Living source: check the version of the individual document.
Original publisher’s resource
Device cybersecurity guidance
Final guidance, February 2026: design, labelling and submission considerations.
Living source: check the version of the individual document.
Original publisher’s resource
CDRH Learn
Official learning modules across the device lifecycle.
Living source: check the version of the individual document.
Original publisher’s resource
EU MDR & IVDR
Official legislation, amendments and implementation resources.
Living source: check the version of the individual document.
Original publisher’s resource
EUDAMED
Actor, device, certificate and market-surveillance modules; check each module’s scope.
Living source: check the version of the individual document.
Original publisher’s resource
MDCG guidance directory
Select the applicable topic, revision and final or draft status.
Living source: check the version of the individual document.
Original publisher’s resource
UK market access
Great Britain and Northern Ireland have different regulatory arrangements.
Living source: check the version of the individual document.
Original publisher’s resource
Medical Devices Active Licence Listing
Check Class II, III and IV device licences and distinguish current from archived records.
Living source: check the version of the individual document.
Original publisher’s resource
Australian device & IVD regulation
Intended purpose, risk classification, conformity assessment and ARTG inclusion.
Living source: check the version of the individual document.
Original publisher’s resource
Saudi marketing authorisation
Official MDS-REQ 1 entry point and its attached requirements.
Living source: check the version of the individual document.
Original publisher’s resource
Japanese approval & certification
Class-specific notification, certification or approval routes and local responsibilities.
Living source: check the version of the individual document.
Original publisher’s resource
IMDRF documents
International regulatory convergence documents, with final and archived versions.
Living source: check the version of the individual document.
Original publisher’s resource
Essential safety & performance principles
A reference framework for devices and IVDs; national implementation still matters.
Living source: check the version of the individual document.
Original publisher’s resource
ISO 13485 — quality management
Publisher overview of ISO 13485. Access to the full standard may require a licence.
Living source: check the version of the individual document.
Public overview; full standard may require a licence.
ISO 14971 — risk management
Publisher description of the device risk-management standard.
Living source: check the version of the individual document.
Public overview; full standard may require a licence.
Medical device procurement
WHO procurement resource guide, 2011; a planning resource, not a market authorisation.
Living source: check the version of the individual document.
Original publisher’s resource
IVD & laboratory procurement
Guidance for procurement of IVDs and related laboratory items and equipment.
Living source: check the version of the individual document.
Original publisher’s resource
PubMed & search methods
Search biomedical citations; document your terms, limits and search date.
Living source: check the version of the individual document.
Original publisher’s resource
PubMed Central: full text
Read openly available journal articles and check each article’s licence.
Living source: check the version of the individual document.
Original publisher’s resource
ClinicalTrials.gov
Find registered studies and posted results; registration is not a finding of effectiveness.
Living source: check the version of the individual document.
Original publisher’s resource
WHO trial registry platform
Search across participating trial registries and follow the original record.
Living source: check the version of the individual document.
Original publisher’s resource
Choose a reporting guideline
Match the reporting checklist to the study design, including CONSORT, STROBE and STARD.
Living source: check the version of the individual document.
Original publisher’s resource
PRISMA: systematic review reporting
Use the reporting checklist and flow diagram; this is not a study-quality score.
Source version / date: PRISMA 2020
Original publisher’s resource
Cochrane methods handbook
Plan evidence synthesis, study selection, risk-of-bias assessment and interpretation.
Source version / date: 6.5 / 2024-08
Original publisher’s resource
STARD: diagnostic accuracy studies
Report diagnostic accuracy studies transparently, with the relevant extensions.
Source version / date: STARD 2015
Original publisher’s resource
Biocompatibility assessment
Consider the finished device, contact, processing and sterilization, where applicable.
Living source: check the version of the individual document.
Original publisher’s resource
Human factors & usability
Connect the intended users, use environment and device interface.
Living source: check the version of the individual document.
Original publisher’s resource
Reprocessing reusable devices
Understand design and validation issues in cleaning, disinfection and sterilization.
Living source: check the version of the individual document.
Original publisher’s resource
MAUDE: reports and limitations
Explore adverse-event reporting; report counts alone do not establish rates or causation.
Living source: check the version of the individual document.
Original publisher’s resource
AccessGUDID: device identifiers
Find device identification information submitted to GUDID.
Living source: check the version of the individual document.
Original publisher’s resource
EMDN nomenclature & training
Explore the nomenclature, version information and official training materials.
Living source: check the version of the individual document.
Original publisher’s resource
Notified bodies & NANDO
Check designation and scope using the Commission’s official links.
Living source: check the version of the individual document.
Original publisher’s resource
Clinical investigations & IVD studies
Distinguish device investigations from IVD performance studies.
Living source: check the version of the individual document.
Original publisher’s resource
Public clinical investigation reports
Access clinical investigation reports and summaries. The page states that performance-study reports will follow later.
Living source: check the version of the individual document.
Original publisher’s resource
EU harmonised standards
Check published references and their scope in the applicable legal framework.
Living source: check the version of the individual document.
Original publisher’s resource
Medical software guidance navigator
Find relevant software guidance across the development and submission lifecycle.
Living source: check the version of the individual document.
Original publisher’s resource
AI-enabled device authorizations
Explore FDA’s list and read the individual authorization record and intended use.
Living source: check the version of the individual document.
Original publisher’s resource
Medical Device Single Audit Program
Understand the program and follow its current official document website.
Living source: check the version of the individual document.
Original publisher’s resource
FDA-recognized consensus standards
Search recognition scope and edition; a standard’s title alone is insufficient.
Living source: check the version of the individual document.
Original publisher’s resource
ASCA & testing laboratories
Check program scope and the current status of participating laboratories.
Living source: check the version of the individual document.
Original publisher’s resource
Equipment maintenance programme
Plan inspection, preventive maintenance and corrective maintenance.
Source version / date: 2011-12-31
Original publisher’s resource
Decommissioning medical devices
Use an organized approach to why, when and how equipment leaves service.
Source version / date: 2019-02-01
Original publisher’s resource
Health technology assessment
Consider clinical, economic, ethical and social value in technology decisions.
Source version / date: 2nd ed. / 2025-05-30
Original publisher’s resource
Inventory & maintenance information systems
Link asset records with management of medical equipment.
Source version / date: 2025-06-04
Original publisher’s resource
Medical oxygen systems
Find technical specifications and resources for oxygen-system planning.
Living source: check the version of the individual document.
Original publisher’s resource
Assistive technology & rehabilitation
Explore assistive products, access, service provision and training resources.
Living source: check the version of the individual document.
Original publisher’s resource
Global atlas of medical devices
Use country profiles as orientation, then verify current national requirements.
Living source: check the version of the individual document.
Original publisher’s resource
Singapore: regulatory overview
Start with product registration, dealer licensing and post-market duties.
Living source: check the version of the individual document.
Original publisher’s resource
Brazil: medical devices
Official overview with links to Brazilian device regulations.
Living source: check the version of the individual document.
Original publisher’s resource
China: medical-device publications
English-language entry point to NMPA publications and original requirements.
Living source: check the version of the individual document.
Original publisher’s resource
India: devices & diagnostics
Official rules, notices and guidance for medical devices and diagnostics.
Living source: check the version of the individual document.
Original publisher’s resource
Switzerland: device oversight
Official entry point for device requirements, safety and vigilance.
Living source: check the version of the individual document.
Original publisher’s resource
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Editorial review: 3 October 2026. Source publication dates and versions remain those of the original publishers.
From source to practice
Prepare your scientific review with clear steps
16 guides across quality, manufacture, registration, safety and research, with scope, source versions and saveable working checklists.