Regulation & global markets
Pathways, authorities, conformity and local responsibilities.
AUPAM / MEDICAL TECHNOLOGY
Medical technology.
A world of knowledge. A place to work.
A working hub for medical devices: market access, quality, IVDs, digital health, procurement, traceability, safety updates and official references.
For manufacturers, regulatory teams, quality professionals, purchasers and clinical engineers.
GLOBAL MARKET DESK
One product. Different market requirements.
Compare 12 markets, select your product and keep a source-linked action plan.
Find your next useful step.
For regulatory teams, manufacturers, researchers, purchasers, clinical engineers and learners — connected through original sources and practical work.
01 / References & literature
58 sources. One searchable library.
Regulators, standards, research methods and literature databases.
Open workspace ↗02 / Learning academyLearn by working through a case.
12 modules, 24 scenarios and a saved learning record.
Open workspace ↗03 / Evidence workspaceBuild a defensible evidence trail.
A literature-search builder and an editable evidence log.
Open workspace ↗04 / Practical toolkitMove from reading to doing.
8 worksheets, local saving, export and print.
Open workspace ↗Explore the field by specialty.
Fourteen routes into the reference library and related lessons.
IVDs & laboratory diagnostics
Performance evidence, procurement and diagnostic-study reporting.
Medical software, AI & cybersecurity
Software evidence, change control and authorization scope.
Manufacturing, quality & audit
Quality systems, standards, test laboratories and evidence.
Sterile supplies & reprocessing
Cleaning, sterilisation, packaging and device-specific instructions.
Implants & biological safety
Contact, finished-device evidence and follow-up questions.
Imaging & active equipment
Applicable testing, intended use, AI and maintenance records.
Dental & reusable instruments
Materials, reprocessing and a traceable quality file.
Procurement, logistics & shortages
Supplier evidence, consumables, lifecycle cost and acceptance.
Clinical engineering & sustainability
Inventory, service, repair support and end-of-life decisions.
Oxygen & respiratory equipment
System planning, technical resources and service requirements.
Assistive & home-use technology
User needs, access, usability and service provision.
Vigilance, recalls & traceability
Official alerts, identifiers and careful interpretation of reports.
Clinical research, literature & HTA
Search, critical appraisal, reporting and value assessment.
01
Start with the task in front of you.
A practical route through the full product lifecycle.
01
Regulatory & market access
Choose a jurisdiction and find its original requirements.
Start here ↗02Manufacturing & quality
Organise the evidence behind your device and its claims.
Start here ↗03Procurement & distribution
Qualify suppliers, plan total cost and preserve traceability.
Start here ↗04Safety & clinical engineering
Follow published alerts, maintenance and lifecycle needs.
Start here ↗Products in scopeMedical equipment · sterile supplies · implants · in vitro diagnostics · medical software · device accessories
02
Understand the market before the submission.
Jurisdiction-specific entry points. Always read the current source.
United StatesFDA
Classify first. Select the right pathway.
Check the intended use, product code and classification. Depending on the device, the route may be exempt, 510(k), De Novo or PMA. Establishment registration is a separate obligation.
- Classification and applicable controls
- Premarket evidence and labelling
- QMSR and post-market responsibilities
European UnionEuropean Commission
Separate MDR from IVDR.
Use MDR for medical devices and IVDR for in vitro diagnostics. Confirm the applicable classification, conformity assessment route and economic-operator responsibilities. Check transitional eligibility in the current legal text.
- Intended purpose and classification rationale
- Technical documentation and clinical or performance evidence
- Conformity assessment, CE marking and EUDAMED
United KingdomMHRA
Great Britain and Northern Ireland: distinct routes.
Check the destination first. Great Britain requires MHRA registration before placement on the market, with a UK Responsible Person for overseas manufacturers. Accepted marking and transition dates depend on the applicable route.
- Destination and legal framework
- Registration and UK Responsible Person
- Applicable marking and vigilance obligations
CanadaHealth Canada
Verify the device licence at the point of purchase.
Use MDALL to check Class II, III and IV device licences. Match the exact device and manufacturer, and distinguish an active licence from an archived entry. A record can change status.
- Exact model and device identifier
- Active versus archived licence
- Separate device and establishment responsibilities
AustraliaTGA
Connect classification to ARTG inclusion.
Review intended purpose, risk class and evidence of conformity. Identify the Australian sponsor and the appropriate ARTG inclusion route or applicable exception. The framework covers IVDs as well as other devices.
- Intended purpose and risk class
- Conformity assessment evidence
- Sponsor, ARTG and continuing obligations
Saudi ArabiaSFDA
Use the Saudi device authorisation requirements.
Start with the SFDA medical-device marketing authorisation requirements and current attachments. Confirm product scope, classification, the responsible local entity and submission requirements for the specific device.
- Product scope and classification
- Current MDS-REQ 1 and relevant attachments
- Local obligations, supply and post-market follow-up
JapanPMDA / MHLW
Notification, certification or approval.
The route depends on risk class and whether certification standards exist. Confirm the role of the Japanese marketing authorisation holder and the applicable PMDA/MHLW procedure.
- Risk class and certification standards
- Japanese responsible entity
- Applicable notification, certification or approval
These are seven selected pathways, not a single global licence. A classification or certificate in one market does not automatically authorise another. For other Arab markets, use the Office’s authority directory and confirm national requirements. Authority & resource directory ↗
03
Build an evidence pack you can review.
Choose a product type, review the relevant prompts and export your working checklist.
Evidence preparation only; this is not a compliance score or approval.
Intended purpose & users
Define claims, user, patient population and use environment.
Regulatory scope & classification
Record the target market, applicable rule and classification rationale.
Product identity & versions
Match names, model numbers, accessories and version boundaries.
Risk-management evidence
Connect hazards, controls, verification and remaining risk.
Quality responsibilities
Identify design, manufacturing, supplier and change-control responsibilities.
Safety & performance evidence
Map each claim to suitable test, clinical or performance evidence.
Label & instructions for use
Check intended purpose, warnings, languages and product identifiers.
Market-access evidence
Verify the actual authorisation or conformity route and its scope.
Traceability & complaint handling
Link units, lots or versions to distribution records and response owners.
Lifecycle & change review
Assign review of modifications, post-market information and corrective actions.
Sterilisation evidence
Document the validated process, release evidence and applicable residuals.
Sterile barrier & transport
Check packaging integrity, distribution conditions and ageing evidence.
Patient-contact materials
Assess biological risks for the contact type and duration.
Shelf life & storage
Use product-specific stability evidence, storage limits and in-use conditions.
Electrical safety & compatibility
Identify applicable electrical, electromagnetic and interoperability evidence.
Installation, calibration & service
Prepare acceptance criteria, service arrangements and critical spare parts.
Usability & use-related risk
Evaluate critical user tasks, foreseeable misuse and training needs.
Specimen & analytical performance
Document sample handling, measuring range, interference and precision as relevant.
Clinical performance & intended setting
Define population, comparator and evidence supporting the intended clinical role.
Reagents, controls & lot acceptance
Plan calibration, quality controls, lot verification and user competence.
Software lifecycle & verification
Track requirements, architecture, testing, anomalies and release versions.
Cybersecurity applicability
Where connected or cyber-enabled, review threats, components, updates and support.
Algorithm & data change control
For AI functions, document data relevance, performance limits and change review.
Selections are saved in this browser only.
Record the evidence reference, reviewer and any non-applicability rationale in the exported worksheet. Apply device-specific requirements; the list is a starting point.
04
Quality is a lifecycle responsibility.
Connect design, suppliers, manufacture, release and post-market evidence.
Quality system
US QMSR has applied since 2 February 2026. Confirm the applicable requirements and exemptions.
Quality Management System RegulationRisk management
Keep risk controls linked to verification and information from actual use.
ISO 14971 — risk managementSafety & performance
Map the relevant essential principles to product-specific evidence.
Essential safety & performance principlesStandards & applicability
Check the edition, recognised scope and local legal role of each standard.
ISO 13485 — quality managementFor the technical file, assess applicable biological, electrical, software, sterilisation, packaging and usability evidence. A standards certificate does not replace product authorisation. Full standards remain with their licensed publishers.
05
Control the journey from purchase to use.
A procurement worklist for equipment, supplies, reagents and their supporting services.
Need & specification
Define the clinical task, setting, capacity and compatible consumables.
Supplier qualification
Verify identity, authorisation scope, quality arrangements and service capability.
Tender & total cost
Compare evidence, availability, consumables, training and lifetime costs.
Shipment & customs
Match licences, invoices, models, quantities and transport requirements.
Receipt & acceptance
Check packaging, expiry, identifiers, supplied documents and acceptance tests.
Storage & distribution
Apply the manufacturer’s product-specific limits; retain delivery traceability.
Service & continuity
Maintain calibration, preventive service, compatible spares and contingency plans.
Recall & end of life
Trace affected units, document action and plan safe decommissioning.
Plan total cost of ownership
Compare one equipment package over the chosen period. Use one currency; values are your inputs, not market quotations. No inflation, discounting or financing is included.
06
Identify the device. Follow the unit.
Keep identifiers tied to the actual product, its version and its distribution history.
A traceable receiving record
- Manufacturer, supplier and legal product name
- Model, catalogue number and device identifier
- Lot, serial number and software version as applicable
- Expiry, quantity, recipient and location
- Storage instructions and transport evidence
- Acceptance decision, exceptions and responsible reviewer
Check the relevant EUDAMED module.
Four modules became mandatory on 28 May 2026: actors, UDI/devices, notified bodies/certificates and market surveillance. The market-surveillance module is for competent authorities and the Commission. Other modules follow a different rollout.
EUDAMED07
Different products. Different evidence.
Use the product-specific checklist and follow the applicable jurisdiction.
In vitro diagnostics
Look beyond the analyser: sample handling, reagents, controls, calibration, stability, lot verification and laboratory capacity belong in the plan.
IVD & laboratory procurementSoftware & connected devices
Connect the intended medical function with software verification, cybersecurity, supported versions and post-market change control.
Device cybersecurity guidanceSterile supplies & accessories
Assess compatibility, patient contact, sterile barrier, shelf life and reprocessing instructions for the actual intended use.
Essential safety & performance principles08
Follow what has actually been published.
Original source date, actual site addition and server monitoring are shown separately.
PUBLISHED SITE RECORDS
Loading device-related records…
Source monitoring status
Checking the server record…
This view draws from the existing published news, enforcement, radar and executive-digest records, with duplicate source links combined. Source monitoring is not proof of a new publication or of complete device coverage in every market.
09
The medical-device reference bank.
Official publishers, a clear purpose for each link, and filters that follow your work.
FDA device regulation
Start with intended use, classification and the applicable US pathway.
Reference link checked: 3 October 2026Quality Management System Regulation
US QMSR, effective 2 February 2026; incorporates ISO 13485:2016 by reference.
Reference link checked: 3 October 2026FDA medical device databases
Classification, 510(k), PMA, De Novo, identifiers and safety-report databases.
Reference link checked: 3 October 2026Device recalls & early alerts
Open the original action and affected-product details.
Reference link checked: 3 October 2026Device cybersecurity guidance
Final guidance, February 2026: design, labelling and submission considerations.
Reference link checked: 3 October 2026CDRH Learn
Official learning modules across the device lifecycle.
Reference link checked: 3 October 2026EU MDR & IVDR
Official legislation, amendments and implementation resources.
Reference link checked: 3 October 2026EUDAMED
Actor, device, certificate and market-surveillance modules; check each module’s scope.
Reference link checked: 3 October 2026MDCG guidance directory
Select the applicable topic, revision and final or draft status.
Reference link checked: 3 October 2026UK market access
Great Britain and Northern Ireland have different regulatory arrangements.
Reference link checked: 3 October 2026Medical Devices Active Licence Listing
Check Class II, III and IV device licences and distinguish current from archived records.
Reference link checked: 3 October 2026Australian device & IVD regulation
Intended purpose, risk classification, conformity assessment and ARTG inclusion.
Reference link checked: 3 October 2026Saudi marketing authorisation
Official MDS-REQ 1 entry point and its attached requirements.
Reference link checked: 3 October 2026Japanese approval & certification
Class-specific notification, certification or approval routes and local responsibilities.
Reference link checked: 3 October 2026IMDRF documents
International regulatory convergence documents, with final and archived versions.
Reference link checked: 3 October 2026Essential safety & performance principles
A reference framework for devices and IVDs; national implementation still matters.
Reference link checked: 3 October 2026ISO 13485 — quality management
Publisher overview of ISO 13485. Access to the full standard may require a licence.
Reference link checked: 3 October 2026ISO 14971 — risk management
Publisher description of the device risk-management standard.
Reference link checked: 3 October 2026Medical device procurement
WHO procurement resource guide, 2011; a planning resource, not a market authorisation.
Reference link checked: 3 October 2026IVD & laboratory procurement
Guidance for procurement of IVDs and related laboratory items and equipment.
Reference link checked: 3 October 2026Publication dates belong to the original documents. The check date is not a new edition date. Guidance, legislation and standards have different legal roles; open the original source for the current version.
10
Build capability, step by step.
A learning route for regulatory, quality, procurement and technical teams.
01 / Regulatory foundations
Define purpose, classification and the destination market.
Open learning source02 / Evidence & quality
Map safety and performance requirements to evidence.
Open learning source03 / Procurement practice
Review the specification, supplier and full ownership cost.
Open learning source04 / Continue learning
Use official modules to deepen a topic and verify its revision.
Open learning sourceSelf-directed reference pathway; no accreditation or certificate is implied. Professional events & workshops ↗
Device-related professional events
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11
Existing device resources, brought together.
A single entry point to the Office’s tools, workflows and related content.
EXISTING OFFICE RESOURCE
Device Regulatory Studio
Explore the existing device tools; confirm outputs against current national requirements.
Open resource ↗EXISTING OFFICE RESOURCEDevice evidence workflow
Open the Office’s existing device review prompts and reference workflow.
Open resource ↗EXISTING OFFICE RESOURCECertificate & evidence review
Organise checks of issuer, scope, dates and product traceability.
Open resource ↗EXISTING OFFICE RESOURCESupply Resilience Studio
Use the existing supply tools with product-specific assumptions.
Open resource ↗EXISTING OFFICE RESOURCEFalsified-product response
Review identity, supply-chain evidence and escalation routes.
Open resource ↗EXISTING OFFICE RESOURCERegulatory response planner
Connect an authority question to evidence, owner and action.
Open resource ↗12
Make the distinctions that matter.
Clear scope helps you use the information correctly.
Does this page determine a device’s legal classification?
No. The market pathway and checklist help organise a review. The intended purpose, applicable rules and competent authority determine the regulatory route.
Is a registered establishment proof of product approval?
Treat establishment registration, product listing, clearance, certification and approval as distinct records. Verify the exact product and decision.
Are all medical supplies regulated the same way?
The intended purpose and local definitions matter. A laboratory item, protective product, accessory or software function may fall under different rules.
Does a published recall affect every unit of a brand?
Read the original notice for the exact model, lot, serial number, version, geography and action. Do not generalise beyond its stated scope.
What updates automatically?
The published-record panel reads the existing site feeds and server status. Reference pages and checklists show their editorial check date; this does not mean every external source is automatically imported.
Editorial and reference-link review: 3 October 2026. This hub supports professional evidence preparation and source navigation.
Editorial standards & corrections ↗Back to top ↑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.