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      CLINICAL LITERATURE          COUNTRIES REGULATIONS, GUIDANCE, & NOTICE           TESTING KIT APPROVALS            CLINICAL TRIALS           RESOURCES BY COUNTRY   
 

 


 

Desktop version only. This page collects all the regulations, guidance, and notices related to Medical Devices & IVDs and 'covid-19' 'sars-cov-2' 'coronavirus'. Featured in the RAPS Covid-19 Resource Center: Highlighted resources. Click here to access and explore more

DATE SOURCE TYPE TITLE
2020-05-29 Swirzerland (SWISSMEDIC) Notice
2020-05-29 United Kingdom (MHRA) Notice Action taken to halt sales of fingerprick coronavirus (COVID-19) antibody testing kits
2020-05-29 Argentina (ANMAT) Event Third cycle of webinars on critical medical products for COVID-19
2020-05-28 Canada (HC) Notice Medical devices for COVID-19: Conducting a clinical trial
2020-05-28 Canada (HC) Notice Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice
2020-05-26 Canada (HC) Guidance Applications for medical device clinical trials under the Interim Order: Guidance document
2020-05-26 USA (FDA) Guidance Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff
2020-05-26 USA (FDA) Guidance Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-05-26 Philippines (FDA) Guidance Interim Guidelines of the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators to be used in the COVID-19 Pandemic
2020-05-25 EU (European Commission) Guidance How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context
2020-05-23 Canada (HC) Regulation Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19
2020-05-22 USA (FDA) Notice Medical Gloves for COVID-19
2020-05-22 USA (FDA) Guidance Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-05-21 Argentina (ANMAT) Event Second cycle of webinars on critical medical products for COVID-19
2020-05-21 Australia (TGA) Guidance Regulation of thermometers and other temperature measuring medical devices for COVID-19
2020-05-20 Australia (TGA) Guidance Reuse of face masks and gowns during the COVID-19 pandemic
2020-05-20 United Kingdom (MHRA) Guidance New section added to Guidance MHRA regulatory flexibilities resulting from coronavirus (COVID-19):  Making use of regulatory flexibilities
2020-05-20 Belgium (AFMPS) Guidance Coronavirus: recommendations for replacing closed suction systems
2020-05-19 Switzerland (Swissmedic) Notice Information regarding the responsibilities of placing protective masks, gloves, hand sanitisers and coronavirus tests on the market
2020-05-19 Japan (PMDA) Notice ICMRA statement on COVID-19
2020-05-19 Brazil (ANVISA) Notice Check rules for respiratory support equipment
2020-05-16  World Health Organisation (WHO) Guidance Cleaning and disinfection of environmental surfaces in the context of COVID-19
2020-05-15 USA (FDA) Report Contacts for Medical Devices During the COVID-19 Pandemic
2020-05-15 Ireland (HPRA) Media HPRA Infographic: Responding to COVID-19
2020-05-15 Brazil (ANVISA) Notice Lung ventilators: see information note
2020-05-15 Brazil (ANVISA) Guidance Tests for Covid-19: questions and answers
2020-05-14 Argentina (ANMAT) Notice On the use of antibody detection tests for COVID-19
2020-05-14 Argentina (ANMAT) Event First cycle of webinars on critical medical products for COVID-19
2020-05-13 World Health Organisation (WHO) Guidance Laboratory biosafety guidance related to coronavirus disease (COVID-19)
2020-05-13 United Kingdom (MHRA) Guidance How tests and testing kits for coronavirus (COVID-19) work
2020-05-13 Canada (HC) Notice Statement from Health Canada on COVID-19 Serological Tests
2019-05-13 Malaysia (MDA) Notice Coronavirus Disease (Covid-19): Special Access
2020-05-13 Japan (PMDA) Notice First Approval of Antigen Test for COVID-19
2020-05-12 Belgium (AFMPS) Guidance Coronavirus: updated guidelines to verify compliance and suitability of surgical mouth masks
2020-05-12 Brazil (ANVISA) Guidance Covid-19: all about face protection masks
2020-05-09 Mexico (COFEPRIS) Guidance Information on ventilators guidelines
2020-05-09 USA (FDA) Guidance Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)- Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
2020-05-08 Brazil (ANVISA) Guidance Covid-19: Learn how to report problems with tests
2020-05-08 Japan (PMDA) Regulation Special Approval for Emergency on Remdesivir for COVID-19
2020-05-08 Brazil (ANVISA) Notice Justice guarantees quick test in pharmacies
2020-05-08 Singapore (HSA) Guidance Guidance on 3-D Printing of Essential Medical Devices and Accessories for Use in COVID-19 (Coronavirus Disease 2019) Situation
2020-05-07 World Health Organisation (WHO) Guidance COVID-19 and the use of angiotensin-converting enzyme inhibitors and receptor blockers
2020-05-07 United Kingdom (MHRA) Guidance Medical devices clinical investigations during the coronavirus (COVID-19) outbreak: Added a new section on Clinical investigations about COVID-19
2020-05-06 USA (FDA) Guidance Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-05-05 USA (FDA) Guidance Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
2020-05-05 USA (FDA) Guidance Medical Gloves for COVID-19: Manufacturing, Purchasing, Importing and Donating Gloves During the Public Health Emergency
2020-05-05 Singapore (HSA) Notice Advisory on products claiming to prevent or treat COVID-19 (Coronavirus Disease 2019)
2020-05-05 Australia (TGA) Notice Australia, Canada, Singapore, Switzerland Consortium regulators pledge support to tackle COVID-19
2020-05-04 United Kingdom (MHRA) Notice Coronavirus: new website for reporting medicines side-effects and equipment incidents
2020-05-04 Brazil (ANVISA) Regulation Covid-19: updated medical device standard (RDC 379/2020)  
2020-05-04 Brazil (ANVISA) Regulation Norm published on import of ICU equipment (RDC 378/2020)
2020-05-01 Swirzerland (SWISSMEDIC) Guidance Placing on the market of important non-conforming medical devices for combating the COVID-19 pandemic
2020-05-01 Australia (TGA) Notice Post-market review of face masks
2020-04-30 Canada (HC) Notice Engaging with international partners on COVID-19
2020-04-29 Brazil (ANVISA) Notice Note clarifies about quick tests
2020-04-28 Brazil (ANVISA) Notice Import of used ICU equipment allowed
2020-04-28 Canada (HC) Guidance Requirements for serological antibody tests submitted under the COVID-19 Interim Order: guidance
2020-04-28 United Kingdom (MHRA) Notice Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak: Added information that we are not currently able to proceed with any new applications to provide ventilators that have not already started.
2020-04-27 EU (European Commission) Guidance MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
2020-04-25 Australia (TGA) Regulation Exemption to enable the domestic manufacture and supply of ventilators
2020-04-24 USA (FDA) Guidance Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry, Clinical Laboratories, Healthcare Facilities, Pathologists, and Food and Drug Administration Staff
2020-04-24 USA (FDA) Guidance Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-04-24 USA (FDA) Guidance Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-04-24 Australia (TGA) Notice Domestic Good Manufacturing Practice (GMP) inspections during the COVID-19 pandemic
2020-04-23 Australia (TGA) Notice COVID-19 point-of-care tests
2020-04-23 Brazil (ANVISA) Notice Covid-19: learn more about rapid tests
2020-04-21 Colombia (INVIMA) Notice Requirements for the assessment of mechanical ventilators prototype of national manufacturing during emergency COVID-19
2020-04-21 Mexico (COFEPRIS) Notice Extraordinary measures in relation to Clinical Studies due to the COVID-19 Pandemic
2020-04-21 Mexico (COFEPRIS) Guidance Provisions for the acquisition and manufacture of ventilators, during the 2019 coronavirus public health emergency (COVID-19)
2020-04-21 Japan (PMDA) Notice Four IVDs Approvals for COVID-19 and Response to the Increased Ventilator Demand
2020-04-20 Kenya (Pharmacy and Poisons Board) Regulation Requirements for Emergency use Authorization of COVID-19 Rapid Test Kits
2020-04-20 Kenya (Pharmacy and Poisons Board)  Guidance Guidance to Sponsors and Investigators for Conduct of Clinical Trials During the Covid-19 Pandemic In Kenya
2020-04-20 Saudi Arabia (SFDA) Guidance Guidance on Requirements for Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories – Recognized Standards
2020-04-20 Philippines (FDA) Notice Varying Specifications and Use of COVID-19 Rapid Antibody Test Kits
2020-04-17 EU (European Commission) Guidance Current performance of COVID-19 test methods and devices and proposed performance criteria - Working document of Commission services
- Annex 1: Commercial devices
- Annex 2: Scientific literature
- Annex 3: Search on validation studies
2020-04-17 Canada (HC) Notice Ventilators for patients with COVID-19
2020-04-17 Brazil (ANVISA) Guidance Pulmonary ventilator: basic step by step for production
2020-04-17 Australia (TGA) Regulation Regulation of thermometers for COVID-19
2020-04-17 Australia (TGA) Guidance Reuse of face masks and gowns during the COVID-19 pandemic
2020-04-17 Australia (TGA) Notice Ventilators and other devices intended for respiratory support for COVID-19
2020-04-17 USA (FDA) Guidance Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
2020-04-17 World Health Organisation (WHO) Guidance Preparedness, prevention and control of coronavirus disease (COVID-19) for refugees and migrants in non-camp settings
2020-04-17 Malaysia (MDA) Guidance MDA/GD/0056: Special access - Requirements for Ventilator during emergency situation
2020-04-16 Canada (HC) Notice Reprocessing of N95 Respirators for Healthcare Professionals
2020-04-16 Canada (HC) Notice Health Product Advertising Incidents related to COVID-19
2020-04-15 Argentina (ANMAT) Regulation Emergency mechanism for the registration of critical medical products class I and II related to the COVID-19 pandemic
2020-04-15 USA (FDA) Guidance Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-04-15 EU (European Commission) Guidance Guidelines on COVID-19 in vitro diagnostic tests and their performance
2020-04-13 Argentina (ANMAT) Regulation Surface disinfectants: extraordinary criteria and procedures for registration in the context of the health emergency by covid-19
2020-04-13 United Kingdom (MHRA) Guidance New opportunities to submitting your proposals for test kits, even when your proposals don't meet our specifications.
2020-04-13 Australia (TGA) Notice Expedited recall system for faulty or unauthorised COVID-19 devices
2020-04-11 Pakistan (DKA) Guidance Fast Track Acceptance Test Procedure for Locally Manufactured Mechanical Ventilators for ICU
2020-04-10 Brazil (ANVISA) Notice Lung ventilators: Brazil expands production
2020-04-09 Nigeria (NAFDAC) Regulation NAFDAC Grants Conditional Emergency Use Approval of Medical Devices (COVID-19 Antibody and Antigen Test Kits, PPEs, etc.) Companies
2020-04-08 EU (European Commission) Guidance Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
2020-04-08 Philippines (FDA) Guidance Interim Guidelines on the Manufacture of Personal Protective Equipment (PPE), Ventilators, and Respirators in Light of COVID-19 Situation
2020-04-08 Australia (TGA) Guidance Manufacturing medical devices for COVID-19 including 3-D printing
2020-04-08 Australia (TGA) Regulation Exemption to enable the domestic manufacture and supply of ventilators
2020-04-07 Argentina (ANMAT) Notice
2020-04-07 Iran (IMED) Guidance Amendments to the instructions for urgent import of medical equipment and supplies needed to control the new corona disease / Types of masks (surgery and filtration), uniform clothing, face protector, thermometer, pulse oximeter, respiratory aids, Corona diagnosis kit
2020-04-07 Singapore (HSA) Regulation HSA's Regulatory Position on Respiratory Devices: Supply for Management of COVID-19 Patients
2020-04-07 India (CDSCO) Regulation Granting permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in the light of Covid-19
2020-04-07 World Health Organisation (WHO) Guidance Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages
2020-04-07 World Health Organisation (WHO) Guidance Advice on the use of masks in the context of COVID-19
2020-04-07 Canada (HC) Notice Medical device shortages
2020-04-07 Canada (HC) Guidance Exceptional importation and sale of medical devices against COVID-19
2020-04-07 Australia (TGA) Guidance COVID-19 point-of-care test
2020-04-07 Australia (TGA) Guidance Ventilator for COVID-19 use in Australia
2020-04-07 USA (FDA) Guidance Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-04-07 USA (FDA) Guidance Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-04-06 Mexico (COFEPRIS) Regulation Provisions for the acquisition and manufacture of ventilators, during the 2019 coronavirus public health emergency (COVID-19)
2020-04-06 Germany (BfArM) Guidance Information for manufacturers, importers and distributors on the special approval of medical mouth and nose protection (MNS) and filtering half masks (FFP2 and FFP3)
2020-04-06 World Health Organisation (WHO) Guidance Coronavirus disease (COVID-19) technical guidance: COVID-19 Critical Items
2020-04-06 EU (European Commission) Guidance Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
2020-04-06 EU (European Commission) Standards IMDRF Standards Checklist modified in scope of COVID-19
2020-04-06 USA (FDA) Guidance Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-04-06 USA (FDA) Guidance Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-04-03 Brazil (ANVISA) Regulation Simplified requirements for surgical masks
2020-04-03 United Kingdom (MHRA) Guidance Guidance on coronavirus (COVID-19) tests and testing kits
2020-04-02 Iran (IMED) Guidance Guide to Classifying Masks / Structures, Applications and Grades of Masks by International Standards
2020-04-02 Japan (PMDA) Workshop Global regulatory workshop on COVID-19 therapeutic development
2020-04-02 Colombia (INVIMA) Guidance Products for the prevention, diagnosis and treatment of COVID-19 with flexible requirements or that do not require approval from Invima for production and importation in the country
2020-04-02 Canada (HC) Notice Personal protective equipment against COVID-19 [2020-04-02]
2020-04-02 Canada (HC) Guidance Important regulatory considerations for the supply of medical gowns – Guidance to Industry [2020-04-02]
2020-04-02 Canada (HC) Notice COVID-19 health product industry 
2020-04-02 USA (FDA) Notice Medical Devices and the COVID-19 (Coronavirus) Pandemic
2020-04-01 United Kingdom (MHRA) Guidance MHRA regulatory flexibilities resulting from coronavirus (COVID-19)
2020-03-31 Japan (PMDA) Notice PMDA pledge to tackle COVID-19 Pandemic
2020-03-30 Argentina (ANMAT) Notice Chinstraps and masks: Information for registration and authorization
2020-03-30 South Africa (SAHPRA) Notice COVID-19 – The Appropriate place for Rapid Test Kits
2020-03-29 World Health Organisation (WHO) Guidance Modes of transmission of virus causing COVID-19:implications for IPC precaution recommendations
2020-03-27 Mexico (COFEPRIS) Regulation DECREE declaring extraordinary actions in the affected regions throughout the national territory in terms of general health to combat the serious disease of priority attention generated by the SARS-CoV2 virus (COVID-19)
2020-03-23 Mexico (COFEPRIS) Regulation DECREE that establishes the Agreement establishing the preventive measures that must be implemented to mitigate and control the health risks of the disease caused by the SARS-CoV2 virus (COVID-19).
2020-03-31 Australia (TGA) Notice Expedited COVID-19 medical device application process
2020-03-31 Australia (TGA) Notice Clinical trial processes
2020-03-30 EU (European Commission) Guidance Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
2020-03-30 EU (European Commission) Guidance Conformity assessment procedures for protective equipment
2020-03-30 EU (European Commission) Guidance Guidance gel hydroalcolic
2020-03-30 EU (European Commission) Notice Commission launches “COVID-19 Clinical Management Support System”
2020-03-30 United Kingdom (MHRA) Guidance Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak
2020-03-30 United Kingdom (MHRA) Guidance Medical devices clinical investigations during the coronavirus (COVID-19) outbreak
2020-03-30 USA (FDA) Guidance Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-03-30 World Health Organisation (WHO) Guidance Modes of transmission of virus causing COVID-19:implications for IPC precaution recommendations
2020-03-27 Spain (AEMPS) Guidance Information on Prototypes of Respirators: Safety Tests and Clinical Investigation Requirements
2020-03-27 World Health Organisation (WHO) Guidance Severe Acute Respiratory Infections Treatment Centre
2020-03-27 Australia (TGA) Guidance How testing works for COVID-19
2020-03-27 Australia (TGA) Notice COVID-19 testing in Australia - information for health professionals
2020-03-27 Australia (TGA) Notice Appropriate use of disinfectants: Information for consumers, health professionals and healthcare facilities
2020-03-26 USA (FDA) Guidance Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
2020-03-26 USA (FDA) Document FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
2020-03-26 Canada (HC) Guidance Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 - Guidance Document
2020-03-26 Canada (HC) Notice Considerations in the use of homemade masks to protect against COVID-19
2020-03-26 Australia (TGA) Notice Regulation of cleaners and disinfectants: Information for sponsors and manufacturers
2020-03-26 Australia (TGA) Notice COVID-19 information for clinicians on ventilators and alternative strategies when in short supply
2020-03-26 Australia (TGA) Notice Hand sanitisers and COVID-19
2020-03-26 World Health Organisation (WHO) Guidance COVID-19: Operational guidance for maintaining essential health services during an outbreak
2020-03-26 United Kingdom (MHRA) Guidance Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
2020-03-26 United Kingdom (MHRA) Guidance Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak
2020-03-26 Saudi Arabia (SFDA) Guidance Guidance on Requirements for Medical Masks - Recognized Standards
2020-03-25 Brazil (ANVISA) Rule Clarifications on CBPF and product prioritization
2020-03-25 United Kingdom (MHRA) Guidance Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
2020-03-25 World Health Organisation (WHO) Guidance Handbook for public health capacity-building at ground crossings and cross-border collaboration
2020-03-25 United Kingdom (MHRA) Guidance How to place a Coronavirus (COVID-19) test kit on the market
2020-03-25 Brazil (ANVISA) Rule Simplified rules for medical devices
The list includes products such as surgical masks, goggles, face shields, respirators and disposable hospital gowns, among others.
2020-03-25 USA (FDA) Notice FDA Statement: Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers
2020-03-25 Brazil (ANVISA) Notice ABNT technical standards are free to access
2020-03-24 Canada (HC) Guidance Optimizing the use of masks and respirators during the COVID-19 outbreak
2020-03-24 World Health Organisation (WHO) Guidance Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease (COVID-19)
2020-03-24 USA (FDA) Notice Letter to Industry on COVID-19
2020-03-23 United Kingdom (MHRA) Guidance Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak
2020-03-23 United Kingdom (MHRA) Form Form Regulatory approval for Coronavirus (COVID-19) test kits
2020-03-23 USA (FDA) Guidance Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
2020-03-23 Australia (TGA) Guidance Legal supply of COVID-19 diagnostic tests
2020-03-20 USA (FDA) Guidance Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 ) Public Health Emergency
2020-03-20 Brazil (ANVISA) Notice Ordinance guides the confrontation of Covid-19 at Anvisa
2020-03-20 Canada (HC) Notice Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19
2020-03-20 Australia (TGA) Notice Supplying COVID-19 tests
2020-03-20 Australia (TGA) Notice Surrogate viruses for use in disinfectant efficacy tests to justify claims against COVID-19
2020-03-20 USA (FDA) Guidance Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
2020-03-19 World Health Organisation (WHO) Guidance Critical preparedness, readiness and response actions for COVID-19
2020-03-19 World Health Organisation (WHO) Guidance Advice on the use of masks in the community, during home care and in healthcare settings in the context of the novel coronavirus (COVID-19) outbreak
2020-03-19 World Health Organisation (WHO) Guidance Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases
2020-03-19 World Health Organisation (WHO) Guidance Infection prevention and control during health care when novel coronavirus (nCoV) infection is suspecte
2020-03-19 India (CDSCO) Notice Notice regarding Regulatory pathway for R&D of IVD kit for diagnosis of COVID-19
2020-03-18 EU (European Commission) Document Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
2020-03-18 USA (FDA) Guidance Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
2020-03-18 Brazil (ANVISA) Notice Companies must report on risk of shortages
2020-03-17 Iran (IMED) Guidance  Guide to Classifying Masks / Structures, Applications and Grades of Masks by International Standards
2020-03-17 Iran (IMED) Guidance  Publication of the guide for the production of nationwide medical clothing (cover clothing) / specifications and features
2020-03-17 Iran (IMED) Guidance Publication of medical mask production guide
2020-03-17 Ecuador (ARCSA) Regulation Resolution Arcsa-de-009-2020-ldcl - the Technical Sanitary Regulation, for the Registration of Products Authorized for Use by Health Emergency. 
2020-03-17 South Africa (SAHPRA) Notice SAHPRA responds to coronavirus (COVID-19): Medicines/medical
devices supply challenges 
2020-03-17 World Health Organisation (WHO) Guidance Population-based age-stratified seroepidemiological investigation protocol for COVID-19 virus infection
2020-03-17 World Health Organisation (WHO) Guidance Home care for patients with COVID-19 presenting with mild symptoms and management of their contacts
2020-03-17 Brazil (ANVISA) Notice Coronavirus: alternatives to GMP certification
2020-03-17 United Kingdom (MHRA) Guidance Find guidance about coronavirus (COVID-19) for health professionals and other organisations.
2020-03-17 Philippines (FDA) Guidance Guidance for Applications and Transactions at the FDA in light of the Community Quarantine Declaration
2020-03-16 World Health Organisation (WHO) Guidance Risk Communication and Community Engagement (RCCE) Action Plan Guidance COVID-19 Preparedness and Response
2020-03-16 World Health Organisation (WHO) Guidance Critical preparedness, readiness and response actions for COVID-19
2020-03-16 EU (European Commission) Rule Regulation (EU) 2020/402 of 14 March 2020 making the exportation of certain products subject to the production of an export authorisation
2020-03-16 USA (FDA) Guidance Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency
2020-03-14 Spain (AEMPS) Rule Royal Decree 463/2020, of March 14, declaring the state of alarm for the management of the health crisis situation caused by COVID-19.
2020-03-13 Brazil (ANVISA) Notice Covid-19: diagnostic products will have priority
2020-03-13 World Health Organisatiob (WHO) Guidance Considerations in the investigation of cases and clusters of COVID-19
2020-03-13 World Health Organisatiob (WHO) Guidance Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected
2020-03-13 USA (FDA) Notice FAQs on Diagnostic Testing for SARS-CoV-2
2020-03-13 Brazil (ANVISA) Rule Coronavirus: alternatives to GMP certification: Resolution of the Collegiate Board (RDC) 346/2020
2020-03-13 United Kingdom (MHRA) Guidance COVID-19: stay at home guidance
2020-03-12 Philippines (FDA) Rule FDA Circular No. 2020-006 || Issuance of Special Certification for Imported Test Kits of COVID-19
2020-03-09 Philippines (FDA) Notice FDA allows use of COVID 19 Test Kits developed by Local Scientist
2020-03-07 World Health Organisatiob (WHO) Guidance Responding to community spread of COVID-19
2020-03-07 World Health Organisatiob (WHO) Guidance Critical preparedness, readiness and response actions for COVID-19
2020-03-06 World Health Organisatiob (WHO) Guidance Disease commodity package - Novel Coronavirus (nCoV)
2020-03-05 World Health Organisatiob (WHO) Guidance The COVID-19 Risk Communication Package For Healthcare Facilities
2020-03-02 USA (FDA) Rule Accelerated Emergency Use Authorization Template for SARS-COV-2 (covid-19) Molecular Testing of Respiratory Specimens in CLIA Certified High-Complexity Laboratories
2020-03-02 Australia (TGA) Rule Exemption for coronavirus (COVID-19) medical devices
2020-03-02 USA (FDA) Guidance Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff
2020-03-02 World Health Organisatiob (WHO) Guidance Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases
2020-03-01 World Health Organisatiob (WHO) Guidance Guidance for laboratories shipping specimens to WHO reference laboratories that provide confirmatory...
2020-02-27 Panama (Ministerio de Salud) Guidance Action Plan Before an Outbreak or Covid-19 Epidemic in National Territory
2020-02-27 World Health Organisatiob (WHO) Guidance Global Surveillance for human infection with coronavirus disease (COVID-19)
2020-02-24 World Health Organisatiob (WHO) Guidance Operational considerations for managing COVID-19 cases/outbreak on board ships
2020-02-12 China (NMPA) Guidance Key Points for Review of New Coronavirus Nucleic Acid Detection Reagent Registration Technology
2020-02-07 Australia (TGA) Notice Warning about products claiming to treat or prevent the novel coronavirus
2020-02-04 World Health Organisatiob (WHO) Guidance Home care for patients with suspected novel coronavirus (nCoV) infection presenting with mild symptoms...
2020-01-30 China (NMPA) Rule Notice regarding the adjustment of medical device acceptance and consultation business arrangements during the pneumonia outbreak of new coronavirus infection
2020-01-29 World Health Organisatiob (WHO) Guidance The First Few X (FFX) Cases and contact investigation protocol for 2019-novel coronavirus (2019-nCoV)...
2020-01-29 World Health Organisatiob (WHO) Guidance Advice on the use of masks in the community, during home care and in healthcare settings in the context...
2020-01-26 World Health Organisatiob (WHO) Guidance Risk communication and community engagement (RCCE) readiness and response to the 2019 novel coronavirus...
2020-01-25 World Health Organisatiob (WHO) Guidance Protocol for assessment of potential risk factors for 2019-novel coronavirus (2019-nCoV) infection among...
2020-01-25 World Health Organisatiob (WHO) Guidance Household transmission investigation protocol for 2019-novel coronavirus (2019-nCoV) infection
2020-01-25 World Health Organisatiob (WHO) Guidance Infection prevention and control during health care when novel coronavirus (nCoV) infection is suspected
2020-01-09 World Health Organisatiob (WHO) Guidance National capacities review tool for a novelcoronavirus