Resources

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Brazil registration webinar 2018
WATCH NOW: Brazil ANVISA Medical Device Registration
Brazil’s medical device industry faced a number of challenges in recent years: a complex regulatory process created long delays for approvals and a
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Brazil's medical device regulatory update
In recent years, ANVISA released numerous regulatory updates to make Brazil a more accessible medical device market. Currently, the medical device
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WATCH NOW: Overview of the MDSAP Certification Process
WATCH NOW: Overview of the MDSAP Certification Process
The Medical Device Single Audit Program (MDSAP) offers a way to streamline the pre- and post-market audit process required by medical device
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NMPA Expectations for Applying Human Factors Engineering (HFE) to Medical Devices
Yvonne Limpens and Ryan Zhang from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights about the NMPA’s HFE
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Medical device registration in China webinar
NMPA medical device registration requirements in China
China represents a vast market for medical devices, but its regulatory system can be difficult to navigate. A recent report published by China’s
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Illustration of a calendar with one date circled
Clinical Evaluation Reports (CER) for Medical Devices
The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR). This scrutiny leaves
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EU flag on a key on a keyboard
2022 Outlook – Updates for Europe’s Regulatory Landscape: Recent Changes in the EU, United Kingdom and Switzerland
Watch this webinar to learn the anticipated updates to the EU IVDR 2017/746 and EU MDR 2017/745, what to look out for from the UK Medicines and
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Illustration of a calendar with one date circled
Extended MDR Date of Application: Optimizing your PMS and clinical activities
Now that the European Medical Devices Regulation (MDR) final date of application has been pushed to May 2021, medical device manufacturers should
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Two human factors researchers wearing surgical masks observe a human factors study of a medical device occurring in an observation room.
Conducting Safe In-person Testing During COVID-19
The experts from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights learned from creating a safe setting to
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