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Blog
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Africa
Kenyan Guidance on Post-Marketing Surveillance: Roles and Responsibilities
Kenyan Guidance on Post-marketing Surveillance: Overview
SAHPRA Guidance on Medical Device Establishment License Renewal
EDA Guidance on UDI: Import, Distribution, and Delivery
EDA Guidance on UDI Requirements for Medical Devices: Specific Requirements
EDA Guidance on UDI Requirements: SaMD and Implantable Devices
EDA Guidance on Requirements for Unique Device Identification for Medical Devices: Basics
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
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Asia
NHRA Guidance on Medical Device Importation Approval: Overview
HSA Guidance on Change Notification: Specific Aspects
HSA Guidance on Change Notification Requirements: Application Process
HSA Guidance on Change Notification: Overview
HSA Guidance on Declaration of Conformity
Turkish Regulation on Clinical Trials: Specific Aspects
HSA Guidance on Clinical Evaluation: Analysis of the Clinical Data
Turkish Regulation on Clinical Trials: Reports and Responsibilities
HSA Guidance on Clinical Evaluation: Data Types and Appraisal
DRAP Guidance on Imports & Exports of Therapeutic Goods: Overview
HSA Guidance on Data Sources for Clinical Evaluation: Literature Review
HSA Guidance on Clinical Evaluation: General Principles
HSA Guidance on Clinical Evaluation: Overview
HSA Guidance on Grouping of Medical Devices: Grouping Categories
HSA Guidance on Grouping of Medical Devices: Overview
HSA Guidance on IVD Classification
HSA Guidance on Labeling for Medical Devices: Implantable Devices and IVDs
HSA Guidance on Labeling: Content of Labeling
Turkish Regulation on Clinical Trials: Responsibilities of the Parties
Turkish Draft Regulation on Clinical Trials: Basics
HSA Guidance on Labeling for Medical Devices: Introduction
Circular on Renewal of Medical Device Licenses – Jordan
HSA Guidance on Product Registration Submissions: ASEAN CSDT in Detail
HSA Guidance on Preparation of a Product Registration Submission: Overview
New Turkish Regulation on Quality Compliance and Control Tests
HSA FAQ on 3D-Printed Medical Devices: Basics
HSA Guidance on Telehealth Products: Classification and Regulatory Controls
HSA Guidance on Telehealth Products: Basics
HSA Guidance on Risk Classification of General Medical Devices: Classification Rules in Detail
PADC Guidance on Registration of High-Risk Medical Devices: Annexes
HSA Guidance on Classification of General Medical Devices: General Principles
HSA Guidance on a Life Cycle Approach for AI-based Medical Devices: Specifics, Post-market Monitoring and Changes
HSA Guidance on Life Cycle Approach for AI-based Devices: Regulatory Basics
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
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Australia and Oceania
TGA FAQ on Software-based Medical Devices
TGA Guidance on Applications for Non-Compliant Devices: Application Form
TGA Guidance on Non-compliant Devices: Basics
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
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Belgium
FAMHP Guidance on Clinical Trials and CTR Pilot Project
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Brazil
ANVISA Guidance on Cybersecurity for Medical Devices
Brazil’s New Rules for Class II Medical Devices
Brazilian Regulation on Medical Software
ANVISA: Brazil Implements Special Regulatory Framework
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Canada
Consultation on Changes to Canadian Medical Device Regulations
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
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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
+
China
Regulatory Status of Combination Products in the US, EU, and China
China Updates Regulations on Medical Device Registration
Understand China’s National Medical Products Administration
+
COFEPRIS
COFEPRIS: Guidance on Ventilators
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Consultant Post
Russian and Eurasian Economic Union (EEU) Regulatory Landscape
10 Things You Need to Know About FDA’s Deficiencies Guidance Document
Insider Tips for CFDA Registrations
Consultant Spotlight: Katrina F.
An Overview of a Medical Device Quality System
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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
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Denmark
+
Ethiopia
EFDA Guidance on Medical Device Labeling: Special Requirements
EFDA Guidance on Medical Device Labeling: Location and Content
EFDA Guidance on Medical Device Labeling: Overview
EFDA Guidelines on Marketing Authorization: Requirements for Virtual Manufacturers
EFDA Guidelines on Marketing Authorization: Post Approval
EFDA Guidelines on Marketing Authorization: Exemptions and Application Review
EFDA Guidance on Application Pathways: Documents and Procedures
EFDA Guidelines on Submission Pathways and Requirements: General Principles and Requirements
EFDA Guidelines on Conformity Assessment of Medical Devices: Documentation
EFDA Guidelines on Conformity Assessment: QMS and Post-Market Surveillance
EFDA Guidelines for Marketing Authorization of Medical Devices: Classification and Grouping, Borderline Products
EFDA Guidance on Storage and Distribution: Dispatch and Outsourced Activities
EFDA Guidance on Storage and Distribution: Personnel, Stock Control, and Other Activities
EFDA Guidance on Storage and Distribution: Premises
EFDA Guidance on Good Storage and Distribution Practice: Recalls
EFDA Guidelines for Marketing Authorization of Medical Devices: Overview
EFDA Guidance on Clearance: Importation in Detail
EFDA Guidance on Storage and Distribution: Management Review, Complaints, and Returned Devices
EFDA Guidance on Requirements of Medical Devices Clearance: Introduction
EFDA Guidelines Storage and Distribution: Quality Assurance
EFDA Guidelines on Storage and Distribution: Introduction
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EU MDR/IVDR
MDCG Guidance on Surveillance Under Transitional Provisions: Specific Aspects
MDCG Guidance on Surveillance Under Transitional Provisions: Overview
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
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Europe
New Italian Rules for Surgical Masks
Swissmedic Guidance on Procurement of Medical Devices: Specific Aspects
EC Implementing Decisions on Harmonized Standards for MDR and IVDR
Czech Regulation on Advertising: Specific Rules
Czech Instruction on Advertising Rules for Medical Devices: General Rules
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
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FDA
FDA Guidance on Fostering Medical Device Improvement: Key Points
FDA on Clinical Studies for Glycemic Control Devices: Specific Aspects
FDA Guidance on a Safer Technologies Program: Mechanisms for Feedback
FDA Guidance on Clinical Studies for Glycemic Control Devices: Duration and Inclusion/Exclusion Criteria
FDA Guidance on STeP: Additional Considerations for Entrance Review
FDA Guidance on Clinical Studies for Glycemic Control Devices: Overview
FDA Guidance on Safer Technologies Program: Eligibility Factors
FDA Guidance on Facet Screw Systems
FDA Guidance on Safer Technologies Program: Principles
FDA Guidance on Quality System Information: Manufacturing Details
FDA Safer Technologies Program: Overview
FDA Guidance on Quality System Information: Design Control Information
FDA Guidance on Quality System Information: Overview
FDA Guidance on Substantial Equivalence: Requests for Performance Data
FDA Guidance on IDEs for Early Feasibility Studies: Specific Aspects
FDA Guidance on Substantial Equivalence: Technological Characteristics
FDA Guidance on IDEs for Early Feasibility Studies: Iterations
FDA Guidance on Substantial Equivalence: Intended Use
FDA Guidance on Investigational Device Exemptions: Investigation Plan
FDA Guidance on Human Factors: Specific Aspects
FDA Guidance on IDEs For Early Feasibility Studies: Specific Aspects of Prior Investigations
FDA Guidance on IDEs For Early Feasibility Studies: Device Evaluation Strategy
FDA Guidance on Human Factors Validation Testing: Analysis and Residual Risk
FDA Guidance on IDEs for Early Feasibility Studies: Report of Prior Investigations
FDA Guidance on Simulated-Use Human Factors Validation Testing: Data Collection
FDA Guidance on Early Feasibility Study IDEs: Key Points
FDA Guidance on Human Factors Validation Testing: Simulated Use and Participants
FDA Guidance on Elimination of Use-Related Hazards and Human Factors Validation Testing
FDA Guidance on IDEs for Early Feasibility Studies: an Overview
FDA Guidance on Human Factors and Usability Engineering: Formative Evaluation
FDA Guidance on Evaluation of Substantial Equivalence: Predicate Devices
FDA Guidance on Human Factors and Usability Engineering: Analytical and Heuristic Approaches
FDA Guidance on Substantial Equivalence: Categories and Decision-Making Flowchart
FDA Guidance on Human Factors and Usability Engineering: Critical Tasks Assessment
FDA Guidance on Substantial Equivalence in Premarket Notifications: Review Standard
FDA Guidance on Human Factors and Usability Engineering: Users, Environment, Interface
FDA Guidance on Human Factors and Usability Engineering: Overview
FDA Guidance on Additive Manufactured Medical Devices: Material Characterization
FDA Guidance on PRO Instruments: Best Practices
FDA Guidance on Patient-Reported Outcome Instruments: Key Principles in Brief
FDA Guidance on Additive Manufactured Medical Devices: Testing Considerations
FDA Guidance on Patient Engagement: Policy in Detail
FDA Guidance on Patient Engagement: Introduction
FDA Guidance on Additive Manufactured Medical Devices: Material Controls, Post-Processing, and Validation
FDA Guidance on Additive Manufactured Medical Devices: Software-Related Aspects
FDA Guidance on Evaluating Substantial Equivalence in Premarket Notifications: Overview
FDA Guidance on Medical Device Reporting: Additional Clarifications
FDA Guidance on Additive Manufactured Medical Devices: Design Process in Brief
FDA Guidance on Additive Manufactured Medical Devices: Definitions and Overview
FDA Guidance on Medical Device Reporting: Completion of the Report
FDA Guidance on Medical Device Reporting: Specific Cases
FDA Guidance on Software Validation: Automated Process Equipment and Quality System Software
FDA Guidance on Additive Manufactured Medical Devices: Basics
FDA Guidance on Software Validation: User Site Testing and Maintenance
FDA Guidance on GUDID Requirements for Certain Devices: Revised Policy
FDA Guidance on the Content of Premarket Submissions for Device Software Functions: Additional Aspects
FDA Guidance on General Principles of Software Validation: Changes and Testing Levels
FDA Guidance on GUDID: Account Roles
FDA Guidance on Content of Premarket Submissions for Device Software Functions: Development and Testing
FDA Guidance on the Safety and Performance Based Pathway: Policy in Detail
FDA Guidance on the Content of Premarket Submission for Device Software Functions: Documents in Detail
FDA Guidance on Safety and Performance Based Pathway
FDA Draft Guidance on Content of Premarket Submissions for Device Software Functions: Introduction
FDA Guidance on Premarket Submissions for Device Software Functions: Definitions and Documentation
FDA Guidance on GUDID: Modules
FDA Guidance on Software Validation Activities: Testing by the Developer
FDA Guidance on GUDID: Device Identifier (DI) Record
FDA Guidance on Software Validation Tasks: Design and Coding
FDA Guidance on De Novo Classification Requests and Review Clock: Requester’s Actions
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
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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
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India
India Amends Medical Device Regulations
The NITI Aayog on Indian Medical Device Regulations
India’s Draft Notification on Regulation of Medical Devices
India Deliberating the Right to Try
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Indonesia
Indonesia’s MoH Introduces New Device Risk Classification System
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IVD
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Japan
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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
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Malaysia
MDA Guidance on Medical Device Advertisement
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MDCG
MDCG Guidance on EUDAMED Alternatives
MDCG Guidance on IVD Classification Rules
MDCG Clinical Evaluation Report Template
MDCG Regulatory Update on Ventilators
MDCG Regulatory Guidance on Clinical Evidence
MDCG Guidance on Clinical Evaluation and Equivalence
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Mexico
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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
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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
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Peru
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Philippines
Philippines FDA Draft Guidance on Distribution Licenses
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Poland
Polish Regulation on Medical Devices: an Overview
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RegDesk News/Info
RegDesk’s AI-Powered Application Builder is revolutionizing regulatory affairs
Why Most RIMS Platforms are Already Obsolete
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!
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Russia
Roszdravnadzor on State Supervision: Control Activities
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
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Saudi Arabia
New SFDA Guidance on Innovative Medical Devices
SFDA Guidance on Safe Use of Medical Devices: Radiation-Related Aspects
SFDA Guidance on Safety for Use of Medical Devices: Overview
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
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Slovenia
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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
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South Korea
South Korea Enforces New IVD Regulation
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switzerland
Swiss Guidance on Procurement of Medical Devices: Overview
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Taiwan
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TGA
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UK
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Uncategorized
RegDesk Presents 6 Tools to Get Your Medical Device to Market Faster
Russian Regulation on State Supervision: Decisions, Appeals, and Criteria
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
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United States
CMS Policy on Artificial Hearts and VADs
AAMI Emergency Use Guidance for Remote Control of Medical Devices
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