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China
China Agent in-country representation for medical devices
ANSWERED ON THIS PAGE: What is the role of the China Agent? What should we consider when choosing a...
Europe
Usability engineering (UE) support for the EU transition to IVDR
ANSWERED ON THIS PAGE: Why should your company want to get an early start on IVDR transition? What...
Europe
In Vitro Diagnostics Regulation (EU IVDR) Training
ANSWERED ON THIS PAGE: What can our employees learn that will help them with IVDR compliance? What...
Europe
EU IVDR 2017/746 Gap Assessment and CE Transition Support for Medical Device Manufacturers
ANSWERED ON THIS PAGE: When does the change from IVDD to IVDR 2017/746 go into effect? What are the...
Mexico
Medical Device and IVD Emergency Use Routes in Mexico
COFEPRIS is the regulatory authority for medical devices and IVDs in Mexico. Approval of these...
Europe
European Authorized Representative for Clinical Trials
ANSWERED ON THIS PAGE: Do you need to select an Authorized Representative for clinical trials in...
Japan
Medical Device and IVD Emergency Use Routes in Japan
Medical devices and IVDs are regulated by the Ministry of Health, Labour, and Welfare (MHLW) in...
India
Medical Device and IVD Emergency Use Routes in India
In India, medical devices and IVDs are regulated by the Drug Controller General of India (DCGI)...
Canada
Canada Emergency Use Pathways for Medical Devices and IVDs
Medical devices and in vitro diagnostic devices (IVDs) are regulated By Health Canada (HC), under...
Europe
Medical Device and IVD Emergency Use Routes in Europe
The EU regulatory framework is based on Directive 93/42/EEC —the “Medical Devices Directive” (MDD...
United States
US FDA Emergency Use Pathways for Medical Devices and IVDs
The US FDA has declared the COVID-19 outbreak to be a public health emergency and invoked their...
Singapore
Singapore Emergency Use Pathways for Medical Devices and IVDs
Singapore Health Sciences Authority (HSA) regulates medical devices and IVDs under the Health...
Brazil
Brazil Emergency Use Pathways for Medical Devices and IVDs
Medical devices and IVDs are regulated by the National Health Surveillance Agency (ANVISA) in...
Australia
Australia Emergency Use Pathways for Medical Devices
Medical devices and IVDs are regulated by the Therapeutic Goods Administration (TGA) in Australia...
Malaysia
Malaysia Emergency Use Pathways for Medical Devices
Medical devices and IVDs are regulated by the Medical Device Authority in Malaysia. The standard...
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© 2021 EMERGO by UL. All Rights Reserved. Privacy Terms of Use Data Subject Access Request Portal

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.