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Device Regulation Library
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Blog
+Africa
- HSA Guidance on Medical Device Product Registration: Class C and D
- HSA Guidance on Medical Device Registration: Basics
- EFDA Guidance on Medical Device Bundling
- Tanzanian Draft Regulation on Laboratory Analysis
- EFDA Guidance on Post-Approval Change Notification
- EFDA Guidelines on Low-Risk Medical Devices
- NDDA Notice on Sample Collection Rules for Medical Devices
- Tanzania on Storage and Distribution of Medical Devices
- Change Control: Ethiopian Guidance for Medical Devices
- ISO Considers Rewriting Their ISO 13485:2016 Standard
- ICMRA Looking to Collaborate with Experts on Track and Trace
- #1 Mistake To Avoid When Registering Your Device Abroad
- How to Come Back from a Denied Product Registration Application
- Multi-Sourcing Intelligence: The Ticket to Regulatory Success
- What You Need to Know About UDI’s
- Tragic Origins of the International Conference on Harmonisation (ICH) and Our Modern FDA
- 5 Tips for Sending your Product to a Emerging Market of Medical Device
- Get to Know: MENA Regulations Authorities
+Asia
- HSA Guidance on Life Cycle Approach for Software Medical Devices: Cybersecurity
- HSA Guidance on Post-Market Management of Software Medical Devices
- HSA Guidance on Life Cycle Approach for Software Medical Devices: Activity Controls and Change Notification
- HSA Guidance on Software Medical Devices: Pre-Market Product Registration Requirements
- HSA Guidance on Software Medical Devices: Basics
- HSA Guidance on 3D-printed Medical Devices
- Oman Guidance on Medical Devices Bundling / Grouping Criteria
- HSA Guidance on IVD Analyzers: SMDR Listing Options
- Oman Guidance on Fast Track High-Risk Medical Devices Registration
- HSA Guidance on IVD Analyzers
- HSA Guidance on Medical Device Advertisements
- HSA Guidance on Medical Device Product Registration: Additional Aspects
- HSA Guidance on Medical Device Advertisement: Basics
- HSA Draft Guidance on Qualification of CDSS
- HSA Consultation on Risk Classification of Standalone Medical Mobile Applications (SaMD)
- HSA Guidance on UDI Implementation Process
- HSA Guidance on Medical Device Unique Device Identification System
- Philippines on Licensing Inspection for Radiation Facilities
- HSA Announces Singapore’s UDI System
- Thailand FDA on Direct Advertising and Labeling
- Taiwan on Registration of Single-Use Medical Devices
- MDA Guidance on Conformity Assessment Body Registration
- Taiwan on Medical Device Safety Monitoring and Surveillance
- Taiwan Draft Guidance on Adverse Event Reporting
- FDA on Water-Circulating Hot/Cold Therapy Devices
- MDA on Requirements for Conformity Assessment Bodies
- MDA on Complaint Handling and Problem Reporting
- MDA Guidance on Field Corrective Action
- PMDA on Cybersecurity Assurance of Medical Devices
- An Overview of South Korea and Their Medical Devices
- Japan Issues Updated Guidance on Biocompatibility Testing
- Japan Amends Medical Device Regulations
- Philippines New Medical Device Regulation Framework
- MFDS New Guidance on Imported and Scarce Medical Devices
- Classification Guidelines for Medical Devices in Bangladesh
- Vietnam Amends Medical Device Regulations – 2019
- MFDS Amended Submission Requirements
- MDA Malaysia’s Guidance on Combination Products
- CDSCO Designates Six Bodies To Perform Manufacturing Site Audits
- Saudi Prepares to Improvise Their Medical Devices Regulation
- Turkey Updates Its Medical Device Regulations
- Medical Device Reimbursement in Japan
- An Overview of Medical Device Regulations in Japan
- Meet this Month’s #WebinarWednesday Speaker: Yoojin Ahn
- Our Guide for How to Register Medical Devices in India
- An Overview of Medical Device Regulations in China
- Philippines FDA Has New Medical Device Regulations in the Pipeline
- MHRA Begins Sharing Intelligence with India to Halt Unlicensed Drug Imports
- India CDSCO Transitions to Online Portal for Blood Products
- Chinese CFDA Adds More Devices Exempt from Clinical Trials
- Saudi Arabia Issues Final Guidance on Medical Device National Registry Route
- India to Authenticate Drugs from Top 300 Pharmaceutical Companies
- #WebinarWednesday Sneak Peek: Medical Device Regulations in Pakistan
- What You Need to Know About Pakistan’s New Medical Device Regulations
- Singapore’s HSA Enhances Legislation to Facilitate Faster Access to Medical Devices
- Malaysian Medical Device Regulations to go into Effect July 1
- India’s CDSCO Plans to Regulate High-End Medical Equipment and Implantable Devices
- Regulatory Roundup from Bahrain
- Answers to Your Most Critical IVD Questions for India
- How Could Changing Manufacturing Facilities Impact Your Device Company?
- China’s CFDA Issues Record Keeping Requirements for Clinical Trial Institutions
- Is There an Pathway for Our Combination Device regulations in Korea, India, Taiwan, and China?
- 4 Things You Need to Know About India’s Notified Bodies
- India’s New Medical Device Regulations: 10 Things You Need to Know
- CFDA Seeks to Streamline Regulations to Align with Other Regulatory Bodies
- CFDA Promises to Accelerate Some Drug Approvals
- Things You Need to Know Before Doing Medical Device Business in Japan
- China Priority Review Option Now Available for Medical Devices
- Quick Primer of the New Device Regulations in India
- Perceived Inconsistency in the Requirements of Clinical Data in Japan
- Medical Device Registration Process in Vietnam
- China’s Solution to Shortage of Vaccines
- New CFDA Regulations on Device Clinical Trials
- CFDA Publishes New Medical Device Naming Rule
- China to Stop Drug Operation for Pharma Companies that Don’t Pass New GSP
- Get to Know: South Asia Regulatory Authorities
- Get to Know: East Asia Regulatory Authorities
- List of Recognized Medical Device Standards Issued By Hong Kong
- Global Medical Device Regulations 101
- How to Register Your Medical Device in India
+Australia and Oceania
- TGA Guidance on Regulated and Unregulated Software: Examples of Regulated Software
- TGA Guidance on Medical Device Incident Reporting: Basics
- TGA Examples of Regulated and Unregulated Software
- TGA Guidance on Surgical Mesh Devices: Preliminary Assessment
- TGA Guidance on Classification of Active Medical Devices: Basics
- TGA Guidance on COVID-related Software: Specific Aspects
- TGA Guidance on Requirements for COVID-related IVDs
- TGA on Regulatory Changes: Software Recommending Treatment
- TGA Guidance on Medical Device Production Systems (MDPS)
- TGA Updates Guidance on Personalized Medical Devices
- TGA on Refinements to the Personalized Medical Devices Framework
- TGA on Regulatory Changes for Software-Based Medical Devices
- TGA Guidance on Implant Cards
- TGA Guidance on Patient Information Leaflets
- TGA Guidance on Medical Software
- TGA Consultation Paper on Medical Devices Applied to the Skin
- TGA Guide on Post Market Review Compliance Dashboard
- TGA on Medical Device Incident Reporting System
- TGA Guidance on Inclusion Process: Application Types
- TGA Guidance on ARTG Registration Step by Step
- TGA Notice on Custom-Made Medical Devices
- TGA: New Australian Framework for Personalized Medical Devices
- TGA Consultation on Regulation of Personalized Medical Devices – Further Details
- TGA Consultation Paper on Proposed Improvements to the Therapeutic Goods Advertising Code
- TGA Consultation on Amendments to Regulation of Personalized Medical Devices
- TGA on Conformity Assessment Bodies
- TGA Guidance on Reclassification of AIMD
- TGA Guidance on Certificates of Free Sale and Export Certificates
- TGA Guidelines on Inclusion Process for Medical Devices (Including IVD)
- TGA Declaration of Conformity for Class I Medical Devices
- TGA on Reclassification of Medicine Delivering Medical Device
- TGA Guidance on Auditing of Medical Device Applications
- TGA Guidance on Supporting Documentation
- TGA on Reclassification of Medical Devices
- TGA: New Details on Clinical Decision Support Software
- TGA Guidance on Clinical Evidence
- TGA Guidance on Seasonal Influenza IVD Self-Tests
- TGA Guidance on Foreign Market Authorization Evidence
- TGA Medical Devices Essential Principles Checklist
- Australian Regulatory Framework on Cybersecurity for Medical Devices
- TGA Consultation on Nanomaterials in Medical Devices
- TGA Guidance on Risk Management Approach
- TGA Guidance on Clinical Decision Support Software
- TGA on Essential Principles for Medical Devices
- MDA Draft Guidance on Medical Device Grouping
- TGA Guidance on Personalized Medical Devices: In-Depth Review
- TGA Guidelines on Personal Protective Equipment
- TGA Guidelines on Sponsorship
- TGA Guidance on Medical Masks and Respirators
- TGA on Post-Market Monitoring and Surveillance of Medical Devices
- TGA Priority Applicant Guidelines for Medical Devices
- TGA on Delays in Conformity Assessment Recertification
- TGA on the Australian Unique Device Identification System
- TGA Consultation on Medical Device Adverse Event Reporting
- Australian Regulatory Guidelines for Medical Devices
- TGA Guidance on 3-D Printing of Medical Devices
- TGA Guidance on Thermal Imaging Systems
- TGA Literature Review of Medical Software Safety Issues
- TGA on Annual Charges Reduction
- TGA on Changes to Implementation Delay
- TGA Summary on Medical Software Consultations
- TGA on Assessment of COVID-19 Tests
- TGA Framework for COVID-19 Tests
- Australia’s TGA Guidance on Thermometers
- TGA Consultation on Software Based Products
- TGA Guidance on Ventilators for COVID-19 in Australia
- Personalised Medical Devices: TGA Regulation Overview
- TGA Guidance on Considerations for Medical Devices
- TGA Consultation Paper on Fees and Charges
- Australia’s Amendments to Medical Device Regulations
- TGA Guidance on IVD Companion Diagnostics
- Overview of Australia’s Therapeutic Goods Administration
- The TGA issues an Update to the Medical Device Regulations
- Updated Australian IMD Registration
- Step-by-Step Guide for How to Register Your Medical Device in Australia
- TGA Proposes Restriction on Pediatric Anesthetic
- Australia’s TGA Delays Implementation of Regulatory Changes for 3D-Printed Devices
- New Online Form for Australian Clinical Trial Notification Scheme
- Medsafe Changes Definitions of Medicines and Medical Devices
+Canada
- Health Canada Guidance on Investigation of Reported Medical Device Incidents: Closure and Additional Details
- Health Canada Guidance on Investigation of Reported Medical Device Problems: Corrective Actions
- Health Canada Guidance on Investigation of Reported Medical Device Problems: Risk Evaluation and Control
- Health Canada Guidance on Problem Report Investigation: Evaluation, Reporting, and Root Cause Investigation
- Health Canada Guidance on Problem Report Investigation: Collecting Information
- Health Canada Guidance on Recalls: Notification and Corrections
- Health Canada Guidance on Recalls: Reporting Process
- Health Canada Guidance on Problem Investigation Procedure
- Health Canada Guidance on Recall Process: Initiating a Recall
- Health Canada Guidance on Ultrasound Systems: Labeling and Quality System Certification
- Health Canada Guidance on Ultrasound Devices: Application Content in Detail
- Health Canada on Incident Reporting: Submission Content and Specific Aspects
- Health Canada on Significant Changes: Guidance for Implementation
- Health Canada Q&A on License Application Types
- Health Canada Notice on Interpretation of Significant Changes
- Health Canada Guidance on License Application Types
- Health Canada Guidance on Recalls: Basics
- Health Canada: Device Licenses for Ultrasonic Diagnostic Systems and Transducers
- Health Canada Guidance on Risk Management for Medical Devices
- Recent Changes to Medical Device Regulations in Canada
- Health Canada Guidance on Private Label Medical Devices
- Health Canada Guidance on IVDD Classification: Special Rules
- Health Canada on Incident Reporting: Timelines and Content
- Health Canada Guidance on Inspections: Advertising, Labelling, and Manufacturing
- Health Canada IVDD Classification Rules Regarding Transmissible Agents
- Health Canada Guidance on MDEL: Annual Review, Updating, Cancellation, and Suspension
- Health Canada Guidance on Classification of IVDDs
- Health Canada Guidance on Inspections of Medical Device Establishments
- Health Canada Guidance on Applying for an MDEL
- Health Canada on Classification of Non-IVD Medical Devices
- Health Canada on Medical Device Establishment Licensing
- Health Canada on Medical Device Shortages
- Health Canada Framework for COVID-related Medical Devices
- Health Canada Guidance on Issue-Related Analyses for Medical Devices
- Health Canada Guidance on Summary Reports
- Health Canada Guidance on Incident Reporting
- Health Canada: Applications for Medical Devices under the Interim Order
- Health Canada Notice on Interim Orders
- Health Canada Notice on UV Decontamination Devices
- FDA Program on Inspections of Combination Products
- Health Canada announces REP Expansion
- Health Canada Guidance on IO Applications
- Health Canada Guidance on Medical Devices
- Health Canada Guidance for Private Label Medical Devices
+Case Study
- FDA Proposes Major Changes to De Novo Pathway
- WHO and FDA Pilot Initiative to Expedite HIV Drug Applications
- FDA to Overhaul 510(k) Device Approval Process
- National Evaluation System for Health Technology (NEST)
- Regulatory Gap Analysis of Centrally Authorized Biologics in the European Union
- How Would Changing Our Distributor Impact the Sale of Our Medical Devices in Taiwan?
- Assessment of Why Japan’s PMDA May Request Clinical Trial Data Instead of Clinical Evaluation Data
- Why Did My Device Registration Application Get Rejected in Brazil?
- Remediation from Distributor Fiasco
- Gap Analysis of Centrally Authorized Drugs in EU
- Case Study – Labeling Review
- 4 Factors Slowing US Approval of Biosimilars and the Future of the Biosimilar Market
- FDA Clears a Material Enabling 3D-Printing of Dentures
- Open FDA Initiative
- STED Explained
+COVID-19
- EC Proposes New In Vitro Diagnostic Medical Devices Regulation
- Saudi Arabia SFDA Guidance on UDI Requirements
- Peru Adopts Regulation on COVID-19 Tests
- FDA Warning on Protective Barrier Enclosures
- FDA Guidance on Multiple Function Device Products
- FDA Template for At-Home and OTC Diagnostic Tests
- FDA Enforcement Policy for Viral Transport Media
- Danish Guidance on Clinical Trials During the Pandemic
- EC: Conformity Assessment of COVID-related Devices
- MHRA Guidance on COVID-related Medical Devices
- FDA Updated Guidance on COVID-19 Tests
- FDA on Decontamination and Bioburden Reduction Systems
- FDA: Meetings and User Fee Applications for Medical Devices
- FDA: Adverse Event Reporting for EUA Medical Devices
- WHO Notice on COVID-related Issues
- FDA Enforcement Policy for ECMO Devices
- MDCG Guidance During COVID-19 Pandemic
- EC Guidance on Medical Devices in the COVID-19 Context
- MHRA Regulatory Flexibilities and COVID-19 Response
- COVID-19: EC Recommendations and Assessment
+EU MDR/IVDR
- MDCG Q&A on Repackaging and Relabeling Activities
- MDCG Guidance on Classification of Medical Devices: Application and Interpretation
- MDCG on Classification of Medical Devices: Terms and Concepts
- MDCG Guidance on Classification of Medical Devices: Basics
- MDCG Guidance on Certification Activities
- SwissMedic Guidance on Obligations of Authorized Representatives, Importers and Distributors
- EMA Guidance on Quality Documentation: Co-packaged Products
- MDCG Guidance on Performance Evaluation of COVID Tests
- EMA Guidance on Medicines Used in Medical Devices
- MDCG Guidance on UDI Integration: Additional Aspects
- EMA Guidance on Documentation for Medicines in Medical Devices
- MDCG Explanatory Note on IVDR Codes
- MDCG Guidance on UDI Integration
- MDCG Joint Implementation Plan for IVDR
- MDCG Guidance: Registration of ‘Other Actors’ in EUDAMED
- MDCG FAQ on the European Medical Device Nomenclature
- MDCG Publishes IVDR Implementation Plan
- Notified Bodies Assessment Procedures Under MDR/IVDR
- MDR and IVDR: Everything You Need to Know
- EC Proposes New AI Medical Device Regulations
- MDCG Q&A Document on Clinical Investigation
- MDCG Guidance on Standardization for Medical Devices
- MDCG Guidance on Certification of Class D IVDs
- Swissmedic on Changes to Medical Device Regulations in Switzerland
- MDCG Guidance on COVID-19 Rapid Antibody Tests
- FDA Guidance on Medical Device Accessories Classification
- MDCG Q&A Document on Custom-Made Medical Devices
- MDCG Visual Guide to Medical Device Software
- HPRA Guidance on Wholesale Distribution Authorizations
- EC Q&A Document on COVID-19 Tests
- UK Final Revision of Medical Devices Regulations
- EC on Management of Legacy Devices
- MHRA on Health Institution Exemption for Northern Ireland
- NBOG on Designation and Notification of Conformity Assessment Bodies
- NBOG Best Practice Guide on Designation and Notification of Conformity Assessment Bodies
- EC Announces the Launch of Actor Registration Module
- MHRA Guidance on Notifying About Clinical Investigation
- Northern Ireland Medical Device Regulation After Brexit
- Peru: Guidelines on COVID-related Medical Devices Validation
- MDCG Post-market Clinical Follow-Up (PMCF)
- MHRA New Medical Device Regulations
- MDGC QA Document on Protective Equipment
- EC Regulation on Single-Use Devices Reprocessing
- EC on the Unique Device Identification System
- MDCG on Person Responsible for Regulatory Compliance
- MDCG on MDSAP Audit Reports and Surveillance Audits
- MDCG Guidance for Class I Medical Device Manufacturers
- IFU for Reusable and Re-sterilizable Devices
- EC Decision on Standardization for Medical Devices
- MDCG on Medical Devices Containing Ancillary Substances
- MDCG Guidance on Safety Reporting in Clinical Investigations
- EU-wide Derogations: Official EC Guidelines
- EC Amends Notified Bodies Designation Procedure
- EU Council Proposal on Regulation Implementation Dates
- Implant Cards: Further MDCG Guidance
- UDI and Changes to UDI’s: MDCG Guidance
- Explanatory Notes to the UK Medical Devices Bill
- Norway Warns on EUDAMED Delay
- MHRA Guidance For Products Without an Intended Medical Purpose
- MedTech Europe Warns on MDR Implementation Issues
- European Commission has Announced New Nomenclature
- Notified Bodies and Conformity Assessment in the EU
- MDCG Issues Guidance On Class I Medical Devices
- AEMPS Provides Additional Time to Change Labels
- Slovenia Implements New Packaging Requirements
- European Council Published Draft of Second Corrigendum to MDR 745
- Eudamed Database Implementation Date Reportedly Delayed
- EC MDCG Issued Guidance in Qualification and Classification of Software Under the MDR/IVDR
- EC Clarifies Status of Expert Panels
- MHRA Guidance about No-Deal Brexit
- DKMA Consultations on MDR
- CE Certificate Renewal Deadline is Approaching
- EU Medical Device Regulations
- AEMPS Applies for NB Designation
- EMA Releases Guidances Addressing Drug Shortages
- EC issued two additional medical device regulation guidances
- MedTech Published a Detailed Plan Regarding MDR/IVDR
- European Commission Warns About Possible Availability Issues
- An Overview Of Medical Device Regulations In Finland
- New Responsibilities for Manufacturers with the new EU MDR
- Spinal Classification under the New EU MDR: Who will Adopt it?
- The Lowdown on Medical Device Regulations in Estonia
- Overview of Medical Device Regulations in Denmark
- Important Things to Know Before Registering your Medical Device in Czech Republic
- An Overview of Medical Device Regulations in the UK
- BSI Warns Device Manufacturers of ‘No-Deal’ Brexit Scenario
- The US and EU Collaborate on UDI Specifications
- The Lowdown on Medical Device Regulations in Sweden
- BSI UK Named First Notified Body Under EU MDR
- Things You Should Know Before Registering Your Medical Devices in Spain
- 6 Major Differences Between EU’s MDR/IVDR and MDD/IVDD
- India’s CDSCO amends Medical Devices Rules to put IVDs on the fast track
- Do Your Labels Comply with the E.U.’s MDR?
- Implementation Timelines for EU MDR and IVDR
- Quick Overview of the EU’s New Medical Device & EU IVD Regulations
+Europe
- MHRA Consultation on the Future Regulation of Medical Devices in the UK
- MHRA Guidance on Temperature Screening Equipment
- Offenses and Liability Under the Medicines and Medical Devices Act 2021
- Legislation Overview: UK Medicines and Medical Devices Act 2021
- Changes to the Swiss Medical Device Regulation
- Recent Regulatory Changes for Medical Devices in Eurasia
- Bosnia and Herzegovina’s Medical Devices Info System: Part II
- Guide to Bosnia and Herzegovina’s Medical Device Information System
- Kazakhstan: New Importation and Exportation Rules
- MedTech Europe Position Paper on Virtual Audits
- Swiss Authorizations for Non-Conforming Medical Devices
- MHRA Response to the IMMDS Review
- Swissmedic Guidance on eCTD v4.0 Implementation
- New Recommendation to Swiss Medical Device Manufacturers
- JAZMP Q&A on Packaging
- MHRA Guidance on 3D Printing of Medical Devices
- Roszdravnadzor on Medical Software Examination
- EC on Medical Devices and PPE in the COVID-19 Context
- Russian Regulation on Medical Device Batch Registration
- EC Guidelines on COVID-19 In-Vitro Diagnostic Tests
- MHRA Guidance on Medicines and Medical Devices
- Team NB Position Paper on Dental Implants
- The UK Announces a New Bill on Medical Devices
- Assistive Technology Medical Device Regulations in the UK
- Brexit Transition Period: EMA and MHRA Notice
- MHRA Guidance on Grace Periods for Notified Bodies
- MHRA Guidance on Clinical Investigations
- Montenegro Law on Medical Devices 2019: an Overview
- MDCG Releases Guidance on Cybersecurity
- Switzerland and the EU on Mutual Recognition Agreements
- MDCG Explanatory Guidance on MDR Codes
- The MDCG’s Class II Medical Device Guidance
- EC MDCG Issues Notified Body Assessment Form
- MDCG Issued Guidance on Transitional Provisions
- EC Extends Application Period for Expert Panels
- UK Healthcare Sector Prepares for No-Deal Brexit
- Ireland’s Preparations for a No-Deal Brexit
- UK to Open Seven New Data Hubs
- German BfArM’s Warning on Medical Device OS Vulnerabilities
- Overview of IVDR
- European Commission Published Guidance on Vigilance System
- The EMA Published Draft Guidance on DDC Products.
- A Guide to Enter Your Medical Device in Italy
- Overview of Ireland’s Registration Process
- Guide to Enter Your Medical Device in Portugal
- New Recommendation to Swiss Medical Device Manufacturers
- A Guide to Enter Your Medical Device in Hungary
- Overview of the Medical Device Regulatory Market in Greece
- Medical Device Regulations in Germany
- Things You Should Know Before Registering Your Medical Devices In France
- Our Guide to Registering Medical Devices in Croatia
- Overview of Medical Device Regulations in Bulgaria
- How to Register Medical Devices in Russia
- An Overview of Medical Device Regulations in Belgium
- An Overview of Medical Device Regulations in Austria
- MEB and Swissmedic Agree On Greater Collaboration
- Swissmedic Moves Certificate Application Processes to Online Platform
- EMA Updates Brexit Guidance Documents for Drugmakers
- The EU’s GDPR is here. Here’s what your healthcare organization needs to know.
- New References Published for EU’s Harmonized OJEU standarts
- Amsterdam Announced as the New Home for EMA
- The Impacts of Brexit on Healthcare
- New Medical Device Regulation in Russia
- New Drug and Device Regulatory Requirements for Eurasian EEU Countries
- Comparing U.S. and E.U. Biosimilar Regulations
- Get to Know: CIS Regulatory Authorities
- Advancements in New EU Medical Device Legislation
+FDA
- FDA Guidance on Surgical Staplers and Staples – Technical Characteristics
- FDA Guidance on De Novo Requests: Review Clock and Goals
- FDA Guidance on Surgical Staplers and Staples for Internal Use – Labelling Recommendations
- FDA Guidance on Software Validation: Activities and Tasks in Brief
- FDA Guidance on GUDID Account: Key Concepts
- FDA Guidance on De Novo Requests and Effect on FDA Review Clock and Goals: FDA Actions
- FDA Guidance on GUDID: Key Points
- FDA Draft Guidance on Hearing Aid Devices
- FDA Guidance on Postmarket Management of Cybersecurity: Additional Aspects
- FDA Guidance on Principles of Software Validation
- FDA Guidance on Remanufacturing Medical Devices: Specific Aspects
- FDA Guidance on Cybersecurity: Remediating and Reporting Cybersecurity Vulnerabilities
- FDA Guidance on Software Validation: Context
- FDA Guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment: Labeling
- FDA Guidance on Remanufacturing Medical Devices: Defining the Scope
- FDA Guidance on Design Control: Design History File
- FDA on Medical Device Cybersecurity Risk Management
- FDA Guidance on Software Contained in Medical Devices: Additional Aspects
- FDA Guidance on Design Control: Design Transfer and Design Changes
- FDA Guidance on BCI Devices: Clinical Performance Testing
- FDA Guidance on Reprocessing Medical Devices: Validation and FDA Review
- FDA on BCI Devices: Animal Testing
- FDA on Acceptance Review for De Novo Requests: the Checklist
- FDA Guidance on Acceptance Review for De Novo Classification Requests
- FDA Guidance on De Novo Framework: Review Process
- FDA Guidance on De Novo Process: Submissions
- FDA Guidance on De Novo Classification Process
- FDA Guidance on Infusion Pumps: Specific Aspects
- FDA Guidance on eSubmission – Current Template
- FDA Draft Guidance on Electronic Submission Template for Medical Device 510(k) Submissions
- FDA Guidance on Reprocessing Medical Devices: Validation of Cleaning
- FDA Guidance on Design Validation
- FDA Guidance on Infusion Pumps: Performance Testing
- FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices: Definitions and General Principles
- FDA Guidance on Infusion Pumps: Hazard Analysis
- FDA Guidance on Design Control: Design Verification
- FDA Guidance on Reprocessing Medical Devices: Criterion 4 – 5 for Reprocessing Instructions
- FDA on Content of Premarket Submissions For Medical Device Software: Documents in Detail
- FDA Draft Guidance on Denture Base Resins
- FDA Guidance on Infusion Pumps: Safety Assurance Cases
- FDA Guidance on Design Control: Design Review
- FDA Guidance on Software Changes: Examples
- FDA Guidance on Mandatory Device Recalls and Corrections
- FDA Guidance on BCI Devices: Non-Clinical Bench Testing
- FDA Guidance on Reprocessing Medical Devices: Criteria 1-3 for Reprocessing Instructions
- FDA Guidance on Medical Device Reporting: Specific Issues
- FDA Guidance on Premarket Submissions for Software Contained in Medical Devices: Documentation
- FDA Guidance on Software Validation: Terminology
- FDA Guidance on Medical Device Reporting: Written Procedures, Record-keeping and Public Disclosure
- FDA Guidance on Recalls: Additional Aspects
- FDA Guidance on Design Control: Design Output
- FDA Guidance on Regulatory Requirements for Device Software Functions
- FDA Guidance on Infusion Pumps: Device Description
- FDA Guidance on Development of Medical Device Labeling
- FDA on Medical Device Reporting: Specific Aspects
- FDA Guidance on BCI Devices: Specific Aspects
- FDA on Labeling For Radiation-Emitting Devices and Light-Emitting Products
- FDA Issues Final Rule Regarding “Intended Use”
- FDA Guidance on Good Manufacturing Practice Labeling Requirements
- FDA on MDR: Manufacturer’s Reporting Requirements in Detail
- FDA on Early Collaboration Meetings: Determination Meetings
- FDA Guidance on Recall Strategy: Development and Execution
- FDA Guidance on Design Control: Design Input
- FDA on Software Changes: Additional Factors
- FDA Policy on Software Functions
- FDA Guidance on Labeling for In Vitro Diagnostic Devices
- FDA Guidance on Manufacturer Reporting Requirements: Awareness and Submission
- FDA on Reusable Medical Devices and Reprocessing
- FDA on Implanted Brain-Computer Interface Devices: Software and Human Factor
- FDA Guidance on Infusion Pumps: Overview
- FDA Guidance on General Device Labeling
- FDA on Electronic Source Data in Clinical Investigations
- FDA Guidance on Recalls and Enhancements
- FDA Guidance on Recalls
- FDA on Postmarket Management of Cybersecurity in Medical Devices
- FDA Guidance on Design Control Basics
- FDA on Cybersecurity Practices for Servicing Medical Devices
- FDA Guidance on Unique Device Identification System
- FDA Guidance on Requests for Information
- FDA on General Principles of Labeling for Medical Devices
- FDA on Manufacturer Reporting Requirements
- FDA Guidance on Reprocessing Medical Devices in Health Care Settings
- FDA Guidance on Early Collaboration Meetings
- FDA Guidance on Electronic Medical Device Reporting (eMDR)
- FDA Safety Communication on Flexible Bronchoscopes
- FDA Guidance on Medical Device Data Systems and Image Devices
- FDA on Mobile Medical Applications: Basics
- FDA on General Principles of Software Validation
- FDA: How to Tell When a Software Change Requires a New 510(K)
- FDA Draft Guidance on Remanufacturing of Medical Devices
- FDA Guidance on Assessment of Radiofrequency-Induced Heating
- FDA on Cybersecurity for Networked Medical Devices Containing OTS Software
- FDA Guidance on Off-The-Shelf Software Use in Medical Devices
- FDA Premarket Submissions for Software Contained in Medical Devices
- FDA on Cybersecurity-related Content of Premarket Submissions
- FDA Guidance on Magnetic Resonance Diagnostic Devices
- FDA Guidance on Reporting of Computational Modeling Studies
- FDA Guidance on Premarket and Postmarket Data Collection
- FDA Guidance on Post-Approval Studies
- FDA on Postmarket Surveillance Under Section 522 of the FD&C Act
- FDA on Investigational Device Exemptions for Early Feasibility Studies
- FDA Guidance on Non-Clinical Bench Performance Testing Information
- FDA Guidance on 510(k) for Software Changes
- FDA Guidance on Feasibility and Early Feasibility Clinical Studies
- FDA Guidance on Implanted Brain-Computer Interface Devices
- FDA Guidance on Testing and Labelling Medical Devices for Safety in the Magnetic Resonance Environment
- FDA Guidance on 510(k) for Changes to Existing Devices
- FDA on Evaluation of Automated Endoscope Reprocessors
- FDA eSTAR Pilot Program
- FDA Medical Device Classification Update
- FDA Guidance on Acceptance and Filing Reviews for PMAs
- FDA Notice on Regulatory Flexibilities and Exemptions
- FDA on 510(k) Acceptability Criteria
- FDA Guidance on Preparing a Pre-Request for Designation
- FDA Guidance on Writing a Request for Designation
- FDA Guidance on Types of Communication
- FDA Guidance on eCopy Program for Medical Device Submissions
- FDA Guidance on Benefit-Risk Factors in Premarket Notifications (510(k))
- FDA on Significant and Nonsignificant Risk Medical Device Studies
- FDA Guidance on Q-Submission Program
- FDA Policy on Viral Mutations and COVID-19 Tests
- FDA Guidance on Patient-Reported Outcome Measures
- FDA Guidance on Intravascular Stents and Associated Delivery Systems
- CDRH on the Patient Science and Engagement Program
- FDA Breakthrough Devices Program: Request, Review, and Features
- FDA Guidance on Safer Technologies Program for Medical Devices
- FDA on Mouse Embryo Assay for Assisted Reproduction Technology Devices
- FDA Breakthrough Devices Program: General Overview
- FDA Guidance on Coagulation Systems for Measurement of Viscoelastic Properties
- FDA Action Plan for AI/ML-Based SaMD
- FDA Guidance on MDSAP Audit Approach
- FDA on Product Labeling for Laparoscopic Power Morcellators
- FDA Criteria for Spinal Plating Systems and Orthopedic Non-Spinal Metallic Bone Screws and Washers
- FDA Virtual Town Hall on COVID-19 Tests
- FDA Proposed Framework for Modifications to AI/ML-Based SaMD
- FDA on Requesting Feedback on Combination Products
- FDA Enforcement Policy for Bioburden Reduction Systems
- FDA on Radio Frequency Wireless Technology in Medical Devices
- FDA on Benefit-Risk Factors for Medical Devices: Key Points
- FDA Guidance on Electromagnetic Compatibility
- FDA Guidance on Certificates of Confidentiality
- FDA Guidance of Micro-Needling Products
- FDA: Requesting a Review of Decision Not to Issue an Export Certificate
- FDA on Exporting Medical Devices
- FDA ASCA Pilot Program in Detail: Development and Roles
- FDA Revised Policy for Remote Monitoring Devices
- FDA: Recognition and Withdrawal of Voluntary Consensus Standards
- FDA Communication Paper on Cybersecurity Vulnerabilities
- FDA Guidance on Medical Devices Containing Nitinol
- FDA Draft Guidance on Biocompatibility of Certain Devices
- FDA Policy for Modifications to Molecular Influenza and RSV Tests
- FDA: Blood Glucose Monitoring Systems for Prescription Point-of-Care Use
- FDA on Biocompatibility Testing of Devices Under ASCA Pilot
- FDA Guidance on Self-Monitoring Blood Glucose Test Systems
- FDA: Basic Safety and Essential Performance of Medical Electrical Equipment
- Taiwan Technical Guidelines on Medical Device Software
- FDA: Accreditation Scheme for Conformity Assessment Pilot Program
- FDA Medical Software Pre-Cert Pilot Program
- FDA Improves the Electronic Medical Device Reporting System
- FDA Guidance on International Standard ISO 10993-1
- FDA: Annual Reports for Approved PMA
- FDA Voluntary Consensus Standards
- FDA: Patient-Reported Outcome Instruments for Use in Evaluation
- FDA to Reclassify Non-Invasive Bone Growth Stimulators
- FDA Guidance on Cutaneous Electrodes for Recording Purposes
- FDA Guidance on the Safety and Performance Based Pathway
- FDA FAQ on Importing, Registration and Listing Medical Devices
- FDA Pilot Program for RFD and Pre-RFD Electronic Submissions
- FDA Amends Medical Device User Fees
- FDA Exemption for Class II Medical Devices
- FDA Guidance on Clinical Investigations for Prostate Tissue Ablation Devices
- FDA Guidance on Electronic 745A(b) Submissions for Medical Devices
- FDA Guidance on BHP Treatment Medical Devices
- SFDA: Listing and Marketing Authorization Requirements
- FDA Policy on Unique Device Identification
- FDA Guidance on Medical Device Establishment Inspections
- FDA Approves First Medical Device Development Tools
- EC Guidelines on Manufacturer Incident Report Form
- FDA Template for Home Collection Kits
- FDA Guidance on Supplements for PMA and HDE Submissions
- Infusion Pumps: FDA Emergency Use Authorization
- FDA: Final Guidance on 3P510K
- CDRH Guidance: Permanent Discontinuance or Interruption
- FDA Umbrella EUA for SARS-CoV-2 Antibody Tests
- FDA Guidance on Remote Digital Pathology Devices
- FDA Enforcement Policy for Telethermographic Systems
- FDA Guidance on Digital Health Devices
- FDA Enforcement Policy for Infusion Pumps and Thermometers
- FDA Guidance on Ventilators and Accessories
- FDA Policy on Remote Auditing Pilot Program
- Monitoring Devices: A New FDA Policy
- FDA Guidance on Clinical Trials During COVID-19 Pandemic
+IMDRF
- IMDRF Consultation Paper on Conformity Assessment Body Recognition
- IMDRF Proposed Framework for PMCF Studies
- IMDRF Framework for SaMD Quality Management System
- IMDRF Framework for SaMD Risk Categorization
- UK COVID-19 Tests Regulation
- IMDRF Framework on Software as a Medical Device
- IMDRF Guidance on Cybersecurity
- IMDRF Guidance on Requirements for CAB Assessors
- IMDRF Proposed Principles of IVD Classification
- Conformity Assessment Guidance from the IMDRF
+IVD
+Kazakhstan
- New Kazakhstan`s Medical Device Manufacturing Rules
- Kazakhstan: NDDA on Labeling Rules
- Kazakhstan’s NDDA on Medical Device Inspections
- Kazakhstan: Methods for Assessment of Optimal Technical Characteristics of Medical Devices
- Kazakhstan: New Medical Device Classification Rules
- Kazakhstan Implements Medical Device Advertising Rules
- Kazakhstan: New Rules on Recalls and Withdrawals
- Kazakhstan Adopts New Rules on Clinical Trials
+MDCG
+MHRA
- MHRA Guidance on Registration of Medical Devices
- MHRA Draft Patient Involvement Strategy
- MHRA on Management and Organization of POCT
- MHRA Guidance on Medical Software and Applications
- MHRA on In-Vitro Diagnostic Point-of-Care Test Devices
- MHRA on Off-Label Use of Medical Devices
- MHRA on Custom-Made Medical Devices
- MHRA on Registration of Medical Device Manufacturers
- MHRA TPP for Point of Care SARS-CoV-2 Detection Tests
- UK: MHRA Notice On Safety-Critical Alerts
- MHRA Guidance on Field Safety Notices
+North America
- FDA Guidance on Third Party Review Program
- FDA Policy on Diagnostics Testing for COVID-19
- FDA Guidance on Third Party Review Program
- FDA Guidance on Electrosurgical Devices
- Document Submissions in Mexico: Guidelines
- Bone Anchor Devices: FDA Guidance
- Overview: FDA NESTcc Methods Framework
- FDA NESTcc Data Quality Framework
- FDA Guidance on CLIA Waiver Applications for IVDs
- Health Canada Implements eCTD for Clinical Trials
- FDA Guidance on Dual 510(k) and CLIA Waivers
- CDRH Introduces New Learning Modules
- FDA Final Guidance on Atherectomy Devices
- FDA Reports on ASCA Implementation Progress
- FDA Guidance on Arthroscopy Pump Tubing Sets
- FDA Guidance on Computer-Assisted Detection Devices
- Clinical Decision Supporting Software: Regulatory Framework
- FDA Guidance on Application Requirements for Devices
- FDA Publishes Order Regarding 510(k) Exemption
- FDA Guidance on Communication Procedures
- FDA Issues Guidance on Testing Information
- FDA Introduces Electronic Medical Device Submission System
- The FDA’s New Medical Device Regulatory Framework
- FDA on Pediatric Medical Device Submission Requirements
- Health Canada Creates the Medical Device Directorate
- CDRH Implements Surveys on Medical Device Shortages
- Recent FDA Guidance on Export Certificates
- The FDA Modifies List of Medical Device Registration Standards
- The FDA Clarifies Requirements on Conformity Assessment
- FDA Guidance on Citizen Petitions Against Applications
- FDA Releases Four Finalized Guidances on 510(k) Submissions
- FDA’s CDRA Warns About Cybersecurity
- FDA Updated Guidance on De Novo Requests
- FDA Finalized Guidance on HDE Program
- FDA’s Guidance on Placebos
- FDA Shifts from QSR and ISO 13485
- FDA Wants To Improve Risk-Based Monitoring In Clinical Trials
- Health Canada Opens Public Consultation About Promotional Ads
- FDA’s Speed Review of Generic Opioid Overdose Anecdotes
- Canada’s Cybersecurity Requirements for Medical Devices
- FDA’s 2018 Cybersecurity Guidance Overview
- FDA Announces Medical Device Reporting Changes
- The Current Regulations of Mobile Health
- Health Canada Increases Regulatory Prices of Medical Devices
- Future of AI/ML-Based SaMD and the Application
- Software Pre-certification Pilot Program (Pre-Cert)
- FDA’s Temporary Framework of AI/ML-based SaMD (part 2)
- FDA’s Temporary Framework of AI/ML-based SaMD (part 1)
- FDA Proposes a Framework to Support Innovative Medical Software
- FDA Released Document on Unapproved Diabetes Management Devices
- RMAT Designation: The Requirements and Benefits
- Health Canada Guidance: Medical Devices and 3-D Printing
- FDA Announced Changes to Reporting Requirements
- FDA Guidance on Medical Devices with Quantitative Imaging
- FDA Safety Communication on Unapproved Medical Devices
- FDA Guidance on Medical Devices Containing Materials Derived from Animal Sources
- FDA Issued a Safety Communication on Cybersecurity Vulnerabilities
- How Will Medical Devices Be Impacted by USMCA?
- FDA to Resume Inspection Activities Amid Government Shutdown
- Health Canada Issues New Plan for Medical Devices
- Important Things to Know Before Registering Your Medical Device in Canada
- An Overview of Medical Device Regulations in the US
- NESTcc Chooses 8 RWE Test Cases to Evaluate Medical Device Performance
- Safe Medical Devices Act (SMDA)
- FDA to Transition to ISO 13485
- The Lowdown on Humanitarian Device Exemption
- What Is FDA Priority Review?
- What Is Fast Track Designation?
- FDA Finalizes Guidance on IRB Written Procedures
- First Non-Opioid Treatment for Opioid Withdrawal Symptoms Approved by FDA
- How the United States Stacks Up Against its Global Competitors in Drug Approvals
- Organizations Push for Change of Clinical Diagnostics Regulations for FDA
- A Time of Change for Marijuana Legalization
- FDA Releases First Ever Medical Device 3D-Printing Guidance
- What Is the Best Way to Identify Your Predicate Device?
- What Do the FDA’s New 510(k) Exemptions Mean for You?
- 3 Things You Need to Know About the FDA’s Digital Health Innovation Plan
- How Will Trump’s Tax Plan Impact Pharmaceutical Companies?
- Cures Act: Signed into law, now comes the hard part
- Can Your Patients Get You to Market Faster?
- Medical Device Tax: On the road to a full repeal?
- FDA Responds to Infusion Pump Controversies
- The Trump Administration’s FDA
- FDA Proposes to Withdraw Lannett and Mallinckrodt’s Concerta Bioequivalents
- RegTech: What It Is and Where It’s Headed
- How to Expedite Drug Approval
- The Cyber-Security of Medical Device Companies
- Clinton vs. Trump on Healthcare
- Reminder: UDI Implementation Due Date Approaching
- Laws Regulating Mobile Health Apps
- How to Maximize the Benefits of the Temporary Medical Device Tax Suspension
- Theranos FDA Scandal: A Closer Look
- Is Selling an Unauthorized Product Worth the Risk?
- Increased Fees for FDA Issued Medical Device Exportation Certificates
- 7 Frequently Asked Questions About Submitting a 510(k) or PMA Under FDA’s New Policies
- How the 4.2% Medical Device User Fee Increase Impacts You
- The Rapid Growth of the Mobile Health Industry in the U.S.
- Getting Mobile Medical Apps Ready for Primetime… and the FDA
- Research Shows Your Device Is Likely at Risk of Being Compromised
- What is a 510(k)?
- Sell Your Medical Device in the US in 3 Steps
- The FDA’s New Era of Test Regulation
+Peru
+RegDesk News/Info
- ANVISA Launches Notification Pathway for Low-Risk Medical Devices
- How to Avoid Pitfalls with Medical Device Distributors
- Best Practices for Partnering with a Medical Device Distributor in Your Target Market
- 4 Ways RegDesk Is Different from Emergo
- RegDesk Appoints Jixian Wang as CTO
- RegDesk Welcomes Hans Beinke, Former VP of Siemens Healthcare, to Its Advisory Board
- Brain Implants: What are they? Where are they going? How are they being Regulated?
- List of Countries without Formal Regulatory Approval Process
- RegDesk CEO, Priya Bhutani, Chosen as 1 of 15 women Changing the Face of Tech in Philadelphia
- Crowdsourcing for Pharma Companies
- All 3 Alliance of Women Entrepreneurs Fellows are DreamIt founders
- How Women Can Advance in the Male-Dominated STEM Industries
- 5 Tips for Sending Your Medical Device to a Sanctioned Country
- Global Medical Device Regulatory Insights
- Regulatory medical device Consultant Spotlight: Maria G.
- Why Having Local Pharma Consultants in Emerging Markets is Vital
- Success Story!
+Russia
- Roszdravnadzor on State Supervision in the Sphere of Medical Devices
- Roszdravnadzor Publishes Regulation on Supervision on Medical Devices
- Russia`s New Medical Software Assessment Rules
- Russian Establishment License Regulation
- Russian Methodical Recommendations for Medical Software Assessment
- Medical Software Classification in Russia
+Saudi Arabia
- Updated SFDA Guidance on Medical Devices Advertising
- SFDA Guidance on Approval Requirements for Medical Device Advertising
- SFDA Guidance on AI and Big Data-Based Medical Devices
- SFDA Guidance on Bundling/Grouping Criteria for Medical Devices
- SFDA Guidelines on Radioactive Materials
- SFDA: Importation Requirements of Devices Intended for Demonstration or Training Purposes Only
- SFDA Guidance On Marketing Authorization Procedures
- SFDA Guidance for Medical Device Importers and Distributors
- SFDA Guidance for Local Manufacturers
- SFDA Guidance for Medical Device Authorized Representatives
- SFDA Guidance for Overseas Manufacturers
- SFDA Guidance on Particle Accelerators
- SFDA on Quality Management System Auditing Organizations
- SFDA: Requirements for Medical Masks and Particulate Respirators
- SFDA Guidance on Requirements of Shipments
- SFDA Guidance on Electronic Instructions for Use Requirements
- SFDA Guidance on Field Safety Corrective Actions
- SFDA Draft Guidance for Combination Products Classification
- SFDA Guidance on Innovative Devices and Standards
- Saudi Arabia’s Platform for Medical Device Submissions
+South America
- Argentina Amends Medical Device Registration Procedures
- Argentina Updates Medical Device Registration Rules
- Our Guide For How to Register Medical Devices In Peru
- Things You Should Know Before Registering Your Medical Devices In Uruguay
- How to register medical devices in Paraguay
- Meet this Month’s #WebinarWednesday Speaker: Marcelo Antunes
- The Lowdown on Medical Device Regulations in Colombia
- How to Register Medical Devices in Mexico
- Our Guide for How to Register Medical Devices in Brazil
- An Overview of Medical Device Regulations in Argentina
- Brazil ANVISA to Wipe Out Existing Backlogs
- COFEPRIS Partners with CAAAREM to Promote Foreign Trade
- Brazil Proposes New Guideline for Importation
- A Sneak Peek into COFEPRIS’s Agenda for 2018
- ANVISA Introduces New Requirement for Clinical Investigation of Medical Devices
- Two New Regulatory Changes in Brazil
- 5 Medical Labeling Requirements In Brazil
- Medical Device Regulations ANMAT Argentina
+TGA
+UK
+Uncategorized
- DGPA & DC Draft Guidance on High-Risk Medical Devices
- TGA Guidance on the Software for Use With COVID-19 Rapid Antigen Self-Tests: Introduction
- TGA Guidance on New Classification Rules for Software-Based Medical Devices (Diagnosing and Monitoring)
- MHRA Guidance on Clinical Investigations: Northern Ireland
- TGA on IVD Software
- SFDA Guidance on Labeling Requirements for Medical Devices
- Thailand Guidance for Medical Device Product Recalls
- FDA Guidance on Adverse Event Reporting During a Pandemic
- MDCG Guidance on Significant Changes
- TGA Timeframes for Regulation of Medical Devices
- Refurbished Medical Devices: Malaysia MDA Draft Guidance
- FDA Medical Device Exemptions and Registration Procedures
- Malaysia Issues Guidance on Orphaned Medical Devices
- Singapore Guidance on Field Safety Corrective Action
- Bahrain Medical Device Registration Guidelines
- Malaysia Issues New Medical Device Regulations
- Health Canada Issues Guidance on SaMD
- ISO Introduces New Risk Management Standard
- IMDRF Clinical Guidelines
- Difference Between ISO 13485: 2012 and 2016
