US: The FDA answers device´s importers questions during COVID-19
The Food and Drug Administration has published two new webpages with instructions on medical device importation, registration and listing amid COVID-19. Meditrial is there to help! – Reach out to us for any kind of assistance in regard of COVID-19 issues related to your device clinical trial or documentation in the US or Europe.
Registration and Listing of Medical Devices during the COVID-19 Pandemic
This webpage includes answers to FAQs about what is required, and what procedures should be followed during the pandemic in regard of registration of medical devices. Device-specific guidances are available for some ventilators and personal protective equipment. Moreover, this page also directs industry to its list of emergency use authorizations (EUAs); facilities whose devices have an EUA “should review the EUA letter of authorization to determine whether the FDA requires you to register and list”.
Importing Medical Devices During the COVID-19 Pandemic
This webpage includes answers to FAQs about importing medical devices during the COVID-19 pandemic. Information is provided in regard to importation of National Institute of Health and Safety (NIOSH)-approved N95 respirators under an EUA specific to those devices.
Among others, The FAQs also discuss other scenarios related to mask importation, such as appropriate product codes to use for various types of masks and how respirators may be imported under the EUA for face masks.
For more details, please see the following pages from the FDA:
Registration and Listing of Medical Devices during the COVID-19 Pandemic
Importing Medical Devices During the COVID-19 Pandemic
Meditrial can help, Contact us now
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
Table of Contents
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
