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We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

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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...
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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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.