All ecosystems
Ecosystem
Global Markets
How the same device is registered across the world's major markets - the agencies, the labels, and the timelines that define a global launch sequence.
117 terms
Regulatory75
- 510(k) Premarket Notification(510(k))
- 510(k) Summary vs 510(k) Statement
- 513(g) Request for Information(513(g))
- Abbreviated 510(k)
- Accreditation Scheme for Conformity Assessment(ASCA)
- Additional Condition for Nonprescription Use(ACNU)
- AI Act Conformity Assessment (Medical Devices)
- AI Act Prohibited Practices
- Analytical Performance (IVDR)
- ANVISA(ANVISA)
- Authorized Representative (EU)(EC REP)
- Breakthrough Device Designation(BDD)
- CE Mark
- Class D Batch Verification (IVDR)
- Class III Device
- Clinical Evaluation Consultation Procedure(CECP)
- Clinical Performance (IVDR)
- Common Specifications(CS)
- Common Specifications (IVDR)(CS)
- Companion Diagnostic (IVDR)(CDx)
- De Novo Classification Request(De Novo)
- Device Master File(MAF)
- Device Reclassification Petition
- Emergency Use Authorization(EUA)
- eSTAR
- EU In Vitro Diagnostic Regulation(IVDR)
- EU Medical Device Regulation(MDR)
- EU Reference Laboratory (EURL)(EURL)
- FDA Recognized Consensus Standards
- General Controls
- General Safety and Performance Requirements(GSPRs)
- General Safety and Performance Requirements (IVDR)(GSPR)
- Genetic Testing Requirements (IVDR Article 4)
- High-Risk AI System (EU AI Act)
- Humanitarian Device Exemption(HDE)
- IMDRF
- Importer and Distributor Obligations (EU)
- In-House IVDs (Article 5(5))
- IVDR Conformity Assessment Routes
- IVDR Legacy Device
- IVDR Performance Evaluation
- IVDR Risk Classes A–D
- IVDR Transitional Provisions
- MDR Article 117
- Medical Device Coordination Group Guidance(MDCG)
- Medical Device User Fee Amendments(MDUFA)
- Metrological Traceability (IVDR)
- MHRA / UKCA Marking(MHRA / UKCA)
- National Medical Products Administration(NMPA)
- NMPA Innovative Medical Device Pathway
- Notified Body(NB)
- Notified Body Scrutiny (IVDR Class D)
- Performance Study Application (IVDR)
- Person Responsible for Regulatory Compliance(PRRC)
- Pharmaceuticals and Medical Devices Agency(PMDA)
- PMA Supplement Types
- Post-Market Performance Follow-Up (IVDR)(PMPF)
- Post-Market Surveillance Plan (IVDR)
- Premarket Approval(PMA)
- Provider and Deployer (EU AI Act)
- Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub)
- Real-Time PMA Supplement Review
- Refuse to Accept(RTA)
- Request for Designation(RFD)
- Safer Technologies Program(STeP)
- Scientific Validity (IVDR)
- Self-Test and Near-Patient Testing (IVDR)
- Special Controls
- Summary of Safety and Clinical Performance(SSCP)
- Summary of Safety and Performance (IVDR)(SSP)
- Swissmedic
- Technical Documentation
- Therapeutic Goods Administration(TGA)
- Third-Party Review of 510(k)(3P 510(k))
- UK Responsible Person(UKRP)
Quality & Risk5
Cybersecurity4
Clinical & Trials8
Standards1
Software & AI5
Manufacturing1
Post-Market13
- 5-Day Report
- Electronic Medical Device Reporting(eMDR)
- FDA Recall Classifications I, II, III
- Field Action vs Recall
- Global Unique Device Identification Database(GUDID)
- Manufacturer Incident Report(MIR)
- Medical Device Recall
- Medical Device Reporting (FDA)(MDR)
- Periodic Safety Update Report(PSUR)
- Post-Market Performance Follow-up(PMPF)
- PSUR (IVDR Specific)
- Section 522 Postmarket Surveillance(Section 522)
- Trend Reporting (MDR/MIR)