We know that many manufacturers and governments are navigating the regulatory environment for medical and personal protective equipment for the first time. We've put together a few documents that will help these organizations to enter this space and/or conduct quality assurance on imported items.
Face masks & coverings
These technical guides on medical and non-medical face masks provide general information, design and testing criteria, and regulatory requirements.
face shields
gowns & coveralls
n95 resources
paprs
ventilators
niv helmets
intubation shields
oxygen concentrators
additional regulatory guidance