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ID
HIGHLIGHTED ONES FOR HE
PRODUCTS
DateJurisdictionTypeLinkTitleComment/Summary
2
HE-Reg-Exc-0001ORG2020-01-09
World Health Organisation (WHO)
Guidance/Recommendation
National capacities review tool for a novelcoronavirus
National capacities review tool for a novelcoronavirus
3
HE-Reg-Exc-0002ALL2020-01-11
World Health Organisation (WHO)
Guidance/Recommendation
Operational Support & Logistics Disease Commodity Packages
Not really applicable to us (referred to by the UK one) but stil interesting
4
HE-Reg-Exc-0003ORG2020-01-25
World Health Organisation (WHO)
Guidance/Recommendation
Protocol for assessment of potential risk factors for 2019-novel coronavirus (2019-nCoV) infection among...
Protocol for assessment of potential risk factors for 2019-novel coronavirus (2019-nCoV) infection among...
5
HE-Reg-Exc-0004ORG2020-01-25
World Health Organisation (WHO)
Guidance/Recommendation
Household transmission investigation protocol for 2019-novel coronavirus (2019-nCoV) infection
Household transmission investigation protocol for 2019-novel coronavirus (2019-nCoV) infection
6
HE-Reg-Exc-0005ORG2020-01-25
World Health Organisation (WHO)
Guidance/Recommendation
Infection prevention and control during health care when novel coronavirus (nCoV) infection is suspected
Infection prevention and control during health care when novel coronavirus (nCoV) infection is suspected
7
HE-Reg-Exc-0006ORG2020-01-26
World Health Organisation (WHO)
Guidance/Recommendation
Risk communication and community engagement (RCCE) readiness and response to the 2019 novel coronavirus...
Risk communication and community engagement (RCCE) readiness and response to the 2019 novel coronavirus...
8
HE-Reg-Exc-0007ORG2020-01-29
World Health Organisation (WHO)
Guidance/Recommendation
The First Few X (FFX) Cases and contact investigation protocol for 2019-novel coronavirus (2019-nCoV)...
The First Few X (FFX) Cases and contact investigation protocol for 2019-novel coronavirus (2019-nCoV)...
9
HE-Reg-Exc-0008ALL2020-01-30China (NMPA)Notice/Regulation
Notice regarding the adjustment of medical device acceptance and consultation business arrangements during the pneumonia outbreak of new coronavirus infection
Notice regarding the adjustment of medical device acceptance and consultation business arrangements during the pneumonia outbreak of new coronavirus infection
10
HE-Reg-Exc-0009ORG2020-02-04
World Health Organisation (WHO)
Guidance/Recommendation
Home care for patients with suspected novel coronavirus (nCoV) infection presenting with mild symptoms...
Home care for patients with suspected novel coronavirus (nCoV) infection presenting with mild symptoms...
11
HE-Reg-Exc-0010ALL2020-02-07Australia (TGA)Notice/Regulation
Warning about products claiming to treat or prevent the novel coronavirus
Warning about products claiming to treat or prevent the novel coronavirus
12
HE-Reg-Exc-0011TEST2020-02-12China (NMPA)
Guidance/Recommendation
Key Points for Review of New Coronavirus Nucleic Acid Detection Reagent Registration Technology
Key Points for Review of New Coronavirus Nucleic Acid Detection Reagent Registration Technology
13
HE-Reg-Exc-0012ORG2020-02-24
World Health Organisation (WHO)
Guidance/Recommendation
Operational considerations for managing COVID-19 cases/outbreak on board ships
Operational considerations for managing COVID-19 cases/outbreak on board ships
14
HE-Reg-Exc-0013ORG2020-02-27
Panama (Ministerio de Salud)
Guidance/Recommendation
Action Plan Before an Outbreak or Covid-19 Epidemic in National Territory
Action Plan Before an Outbreak or Covid-19 Epidemic in National Territory
15
HE-Reg-Exc-0014ORG2020-02-27
World Health Organisation (WHO)
Guidance/Recommendation
Global Surveillance for human infection with coronavirus disease (COVID-19)
Global Surveillance for human infection with coronavirus disease (COVID-19)
16
HE-Reg-Exc-0015ORG2020-03-01
World Health Organisation (WHO)
Guidance/Recommendation
Guidance for laboratories shipping specimens to WHO reference laboratories that provide confirmatory...
Guidance for laboratories shipping specimens to WHO reference laboratories that provide confirmatory...
17
HE-Reg-Exc-0016ALL2020-03-02Australia (TGA)Notice/Regulation
Exemption for coronavirus (COVID-19) medical devices
Exemption for coronavirus (COVID-19) medical devices
18
HE-Reg-Exc-0017TEST2020-03-02USA (FDA)Notice/Regulation
Accelerated Emergency Use Authorization Template for SARS-COV-2 (covid-19) Molecular Testing of Respiratory Specimens in CLIA Certified High-Complexity Laboratories
Accelerated Emergency Use Authorization Template for SARS-COV-2 (covid-19) Molecular Testing of Respiratory Specimens in CLIA Certified High-Complexity Laboratories
19
HE-Reg-Exc-0018ORG2020-03-05
World Health Organisation (WHO)
Guidance/Recommendation
The COVID-19 Risk Communication Package For Healthcare Facilities
The COVID-19 Risk Communication Package For Healthcare Facilities
20
HE-Reg-Exc-0019ORG2020-03-06
World Health Organisation (WHO)
Guidance/Recommendation
Disease commodity package - Novel Coronavirus (nCoV)
Disease commodity package - Novel Coronavirus (nCoV)
21
HE-Reg-Exc-0020ORG2020-03-07
World Health Organisation (WHO)
Guidance/Recommendation
Responding to community spread of COVID-19
Responding to community spread of COVID-19
22
HE-Reg-Exc-0021TEST2020-03-09Philippines (FDA)Notice/Regulation
FDA allows use of COVID 19 Test Kits developed by Local Scientist
FDA allows use of COVID 19 Test Kits developed by Local Scientist
23
HE-Reg-Exc-0022TEST2020-03-12Philippines (FDA)Notice/Regulation
FDA Circular No. 2020-006 || Issuance of Special Certification for Imported Test Kits of COVID-19
FDA Circular No. 2020-006 || Issuance of Special Certification for Imported Test Kits of COVID-19
24
HE-Reg-Exc-0023ORG2020-03-13
World Health Organisation (WHO)
Guidance/Recommendation
Considerations in the investigation of cases and clusters of COVID-19
Considerations in the investigation of cases and clusters of COVID-19
25
HE-Reg-Exc-0024ORG2020-03-13
World Health Organisation (WHO)
Guidance/Recommendation
Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected
Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected
26
HE-Reg-Exc-0025ORG2020-03-13
United Kingdom (MHRA)
Guidance/Recommendation
COVID-19: stay at home guidance
COVID-19: stay at home guidance
27
HE-Reg-Exc-0026TEST2020-03-13Brazil (ANVISA)Notice/Regulation
Covid-19: diagnostic products will have priority
Covid-19: diagnostic products will have priority
28
HE-Reg-Exc-0027TEST2020-03-13USA (FDA)Notice/Regulation
FAQs on Diagnostic Testing for SARS-CoV-2
FAQs on Diagnostic Testing for SARS-CoV-2
29
HE-Reg-Exc-0028ORG2020-03-14EU (Spain - AEMPS)Notice/Regulation
Royal Decree 463/2020, of March 14, declaring the state of alarm for the management of the health crisis situation caused by COVID-19.
Royal Decree 463/2020, of March 14, declaring the state of alarm for the management of the health crisis situation caused by COVID-19.
30
HE-Reg-Exc-0029ALL2020-03-16
EU (European Commission)
Notice/Regulation
Regulation (EU) 2020/402 of 14 March 2020 making the exportation of certain products subject to the production of an export authorisation
Making the exportation of certain products subject to the production of an export authorisation
31
HE-Reg-Exc-0030TEST2020-03-16USA (FDA)
Guidance/Recommendation
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency
32
HE-Reg-Exc-0031ALL2020-03-17Ecuador (ARCSA)Notice/Regulation
Resolution Arcsa-de-009-2020-ldcl - the Technical Sanitary Regulation, for the Registration of Products Authorized for Use by Health Emergency.
Resolution Arcsa-de-009-2020-ldcl - the Technical Sanitary Regulation, for the Registration of Products Authorized for Use by Health Emergency.
33
HE-Reg-Exc-0032ALL2020-03-17Brazil (ANVISA)Notice/Regulation
Coronavirus: alternatives to GMP certification
Coronavirus: alternatives to GMP certification
34
HE-Reg-Exc-0033ALL2020-03-17Philippines (FDA)
Guidance/Recommendation
Guidance for Applications and Transactions at the FDA in light of the Community Quarantine Declaration
Guidance for Applications and Transactions at the FDA in light of the Community Quarantine Declaration
35
HE-Reg-Exc-0034ORG2020-03-17South Africa (SAHPRA)Notice/Regulation
SAHPRA responds to coronavirus (COVID-19): Medicines/medical
devices supply challenges
SAHPRA responds to coronavirus (COVID-19): Medicines/medical
devices supply challenges
36
HE-Reg-Exc-0035ORG2020-03-17
World Health Organisation (WHO)
Guidance/Recommendation
Population-based age-stratified seroepidemiological investigation protocol for COVID-19 virus infection
Population-based age-stratified seroepidemiological investigation protocol for COVID-19 virus infection
37
HE-Reg-Exc-0036ORG2020-03-17
World Health Organisation (WHO)
Guidance/Recommendation
Home care for patients with COVID-19 presenting with mild symptoms and management of their contacts
Home care for patients with COVID-19 presenting with mild symptoms and management of their contacts
38
HE-Reg-Exc-0037ORG2020-03-17
United Kingdom (MHRA)
Guidance/Recommendation
Find guidance about coronavirus (COVID-19) for health professionals and other organisations.
Find guidance about coronavirus (COVID-19) for health professionals and other organisations.
39
HE-Reg-Exc-0038ORG2020-03-17USA (FDA)
Guidance/Recommendation
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency
Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency
40
HE-Reg-Exc-0039####ALL2020-03-18
EU (European Commission)
Guidance/Recommendation
Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
41
HE-Reg-Exc-0040ALL2020-03-18USA (FDA)
Guidance/Recommendation
Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
42
HE-Reg-Exc-0041ORG2020-03-18Brazil (ANVISA)Notice/Regulation
Companies must report on risk of shortages
Companies must report on risk of shortages
43
HE-Reg-Exc-0042ORG2020-03-19
World Health Organisation (WHO)
Guidance/Recommendation
Critical preparedness, readiness and response actions for COVID-19
Critical preparedness, readiness and response actions for COVID-19
44
HE-Reg-Exc-0043PPE2020-03-19
World Health Organisation (WHO)
Guidance/Recommendation
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
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
45
HE-Reg-Exc-0044TEST2020-03-19
World Health Organisation (WHO)
Guidance/Recommendation
Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases
Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases
46
HE-Reg-Exc-0045TEST2020-03-19India (CDSCO)Notice/Regulation
Notice regarding Regulatory pathway for R&D of IVD kit for diagnosis of COVID-19
Notice regarding Regulatory pathway for R&D of IVD kit for diagnosis of COVID-19
47
HE-Reg-Exc-0046ALL2020-03-20Canada (HC)Notice/Regulation
Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19
Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19
48
HE-Reg-Exc-0047ALL2020-03-20USA (FDA)
Guidance/Recommendation
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
49
HE-Reg-Exc-0048DISINFECT2020-03-20Australia (TGA)Notice/Regulation
Surrogate viruses for use in disinfectant efficacy tests to justify claims against COVID-19
Surrogate viruses for use in disinfectant efficacy tests to justify claims against COVID-19
50
HE-Reg-Exc-0049MONITOR2020-03-20USA (FDA)
Guidance/Recommendation
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 ) Public Health Emergency
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 ) Public Health Emergency
51
HE-Reg-Exc-0050ORG2020-03-20Brazil (ANVISA)Notice/Regulation
Ordinance guides the confrontation of Covid-19 at Anvisa
Ordinance guides the confrontation of Covid-19 at Anvisa
52
HE-Reg-Exc-0051TEST2020-03-20Australia (TGA)Notice/RegulationSupplying COVID-19 tests
Supplying COVID-19 tests
53
HE-Reg-Exc-0052ALL2020-03-22USA (FDA)
Guidance/Recommendation
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals
Risk Mitigations
54
HE-Reg-Exc-0053PPE2020-03-22Australia (TGA)Notice/Regulation
https://www.legislation.gov.au/Series/F2020N00033
Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020
Only record keping/audirable requirement if supply "under a contract between the person and the Australian Government Department of Health, or another agency of the Commonwealth acting on behalf of Australian Government Department of Health
55
HE-Reg-Exc-0054ORG2020-03-23Mexico (COFEPRIS)Notice/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).
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).
56
HE-Reg-Exc-0055TEST2020-03-23
United Kingdom (MHRA)
Procedure/Form/Template
Form Regulatory approval for Coronavirus (COVID-19) test kits
Form Regulatory approval for Coronavirus (COVID-19) test kits
57
HE-Reg-Exc-0056TEST2020-03-23Australia (TGA)
Guidance/Recommendation
Legal supply of COVID-19 diagnostic tests
Legal supply of COVID-19 diagnostic tests
58
HE-Reg-Exc-0057VENT2020-03-23USA (FDA)
Guidance/Recommendation
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
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
59
HE-Reg-Exc-0058ALL2020-03-24USA (FDA)Notice/RegulationLetter to Industry on COVID-19
Letter to Industry on COVID-19
60
HE-Reg-Exc-0059ORG2020-03-24
World Health Organisation (WHO)
Guidance/Recommendation
Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease (COVID-19)
Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease (COVID-19)
61
HE-Reg-Exc-0060ORG2020-03-24USA (FDA)
Guidance/Recommendation
CVM GFI #269 - Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak
CVM GFI #269 - Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak
62
HE-Reg-Exc-0061PPE2020-03-24Canada (HC)
Guidance/Recommendation
Optimizing the use of masks and respirators during the COVID-19 outbreak
Optimizing the use of masks and respirators during the COVID-19 outbreak
63
HE-Reg-Exc-0062ALL2020-03-25Brazil (ANVISA)Notice/Regulation
Clarifications on CBPF and product prioritization
Clarifications on CBPF and product prioritization
64
HE-Reg-Exc-0063ALL2020-03-25
United Kingdom (MHRA)
Guidance/Recommendation
Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
65
HE-Reg-Exc-0064ORG2020-03-25
World Health Organisation (WHO)
Guidance/Recommendation
Handbook for public health capacity-building at ground crossings and cross-border collaboration
Handbook for public health capacity-building at ground crossings and cross-border collaboration
66
HE-Reg-Exc-0065PPE2020-03-25Brazil (ANVISA)Notice/Regulation
Simplified rules for medical devices
The list includes products such as surgical masks, goggles, face shields, respirators and disposable hospital gowns, among others.
Simplified rules for medical devices
The list includes products such as surgical masks, goggles, face shields, respirators and disposable hospital gowns, among others.
67
HE-Reg-Exc-0066PPE2020-03-25USA (FDA)
Guidance/Recommendation
FDA Statement: Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers
FDA Statement: Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers
68
HE-Reg-Exc-0067TEST2020-03-25
United Kingdom (MHRA)
Guidance/Recommendation
How to place a Coronavirus (COVID-19) test kit on the market
How to place a Coronavirus (COVID-19) test kit on the market
69
HE-Reg-Exc-0068ALL2020-03-26USA (FDA)
Guidance/Recommendation
FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
70
HE-Reg-Exc-0069ALL2020-03-26Canada (HC)
Guidance/Recommendation
Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 - Guidance Document
Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 - Guidance Document
71
HE-Reg-Exc-0070ALL2020-03-26
World Health Organisation (WHO)
Guidance/Recommendation
COVID-19: Operational guidance for maintaining essential health services during an outbreak
COVID-19: Operational guidance for maintaining essential health services during an outbreak
72
HE-Reg-Exc-0071ALL2020-03-26
United Kingdom (MHRA)
Guidance/Recommendation
Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
73
HE-Reg-Exc-0072DISINFECT2020-03-26Australia (TGA)Notice/Regulation
Regulation of cleaners and disinfectants: Information for sponsors and manufacturers
Regulation of cleaners and disinfectants: Information for sponsors and manufacturers
74
HE-Reg-Exc-0073DISINFECT2020-03-26Australia (TGA)Notice/RegulationHand sanitisers and COVID-19
Hand sanitisers and COVID-19
75
HE-Reg-Exc-0074Other2020-03-26USA (FDA)
Guidance/Recommendation
Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency
Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency
76
HE-Reg-Exc-0075PPE2020-03-26USA (FDA)
Guidance/Recommendation
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
"FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available."
77
HE-Reg-Exc-0076PPE2020-03-26Canada (HC)Notice/Regulation
Considerations in the use of homemade masks to protect against COVID-19
Considerations in the use of homemade masks to protect against COVID-19
78
HE-Reg-Exc-0077PPE2020-03-26Saudi Arabia (SFDA)
Guidance/Recommendation
Guidance on Requirements for Medical Masks - Recognized Standards
Guidance on Requirements for Medical Masks - Recognized Standards
79
HE-Reg-Exc-0078VENT2020-03-26Australia (TGA)Notice/Regulation
COVID-19 information for clinicians on ventilators and alternative strategies when in short supply
COVID-19 information for clinicians on ventilators and alternative strategies when in short supply
80
HE-Reg-Exc-0079VENT2020-03-26
United Kingdom (MHRA)
Guidance/Recommendation
Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak
Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak
ANR
81
HE-Reg-Exc-0080DISINFECT2020-03-27Australia (TGA)Notice/Regulation
Appropriate use of disinfectants: Information for consumers, health professionals and healthcare facilities
Appropriate use of disinfectants: Information for consumers, health professionals and healthcare facilities
82
HE-Reg-Exc-0081DISINFECT2020-03-27USA (FDA)
Guidance/Recommendation
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
83
HE-Reg-Exc-0082DISINFECT2020-03-27USA (FDA)
Guidance/Recommendation
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
84
HE-Reg-Exc-0083ORG2020-03-27Mexico (COFEPRIS)Notice/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)
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)
85
HE-Reg-Exc-0084ORG2020-03-27
World Health Organisation (WHO)
Guidance/Recommendation
Severe Acute Respiratory Infections Treatment Centre
Severe Acute Respiratory Infections Treatment Centre
86
HE-Reg-Exc-0085ORG2020-03-27USA (FDA)
Guidance/Recommendation
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry
87
HE-Reg-Exc-0086PPE2020-03-27EU (Spain - AEMPS)
Guidance/Recommendation
Information on Prototypes of Respirators: Safety Tests and Clinical Investigation Requirements
Information on Prototypes of Respirators: Safety Tests and Clinical Investigation Requirements
88
HE-Reg-Exc-0087TEST2020-03-27Australia (TGA)
Guidance/Recommendation
How testing works for COVID-19
How testing works for COVID-19
89
HE-Reg-Exc-0088TEST2020-03-27Australia (TGA)Notice/Regulation
COVID-19 testing in Australia - information for health professionals
COVID-19 testing in Australia - information for health professionals
90
HE-Reg-Exc-0089VENT2020-03-27USA (FDA)
Procedure/Form/Template
Ventilator Emergency Use Authorization (EUA) Interactive Review Memo
To contact the FDA via review template to authorize modificaiton of existing Vents or other nmachines (BiPAP)
91
HE-Reg-Exc-0090ALL2020-03-27USA (FDA)
Guidance/Recommendation
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
92
HE-Reg-Exc-0091DISINFECT2020-03-27USA (FDA)
Guidance/Recommendation
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
93
HE-Reg-Exc-0092DISINFECT2020-03-29USA (FDA)
Guidance/Recommendation
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
94
HE-Reg-Exc-0093ALL2020-03-30
EU (European Commission)
Guidance/Recommendation
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
95
HE-Reg-Exc-0094ALL2020-03-30
United Kingdom (MHRA)
Guidance/Recommendation
Medical devices clinical investigations during the coronavirus (COVID-19) outbreak
Medical devices clinical investigations during the coronavirus (COVID-19) outbreak
96
HE-Reg-Exc-0095DISINFECT2020-03-30
EU (European Commission)
Guidance/Recommendation
Guidance gel hydroalcolic
Guidance gel hydroalcolic
97
HE-Reg-Exc-0096ORG2020-03-30
EU (European Commission)
Notice/Regulation
Commission launches “COVID-19 Clinical Management Support System”
Commission launches “COVID-19 Clinical Management Support System”
98
HE-Reg-Exc-0097PPE2020-03-30
EU (European Commission)
Guidance/Recommendation
Conformity assessment procedures for protective equipment
Conformity assessment procedures for protective equipment
99
HE-Reg-Exc-0098PPE2020-03-30
World Health Organisation (WHO)
Guidance/Recommendation
Modes of transmission of virus causing COVID-19:implications for IPC precaution recommendations
Modes of transmission of virus causing COVID-19:implications for IPC precaution recommendations
100
HE-Reg-Exc-0099PPE2020-03-30USA (FDA)
Guidance/Recommendation
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency