Rule 21 Hyaluronic Acid based eye drops
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EU MDR
Regulatory Resources
MedTech Regulatory & Quality Resource Hub
Digital Health Taiwan: Fostering the best ecosystem
Taiwan occupies a unique position in the Asia-Pacific region. As a middle-income society, it is a suitable environment for incubating novel digitalization concepts. The market size is ideal for a first launch in Asia, the population well versed in technology, internet access is considered a human ri
Digital Health
Unregulated: A Diverse Regulatory Affairs Professional Story
I recently read an article on increasing Diversity in the Regulatory Affairs Profession. I was quite excited at first, and even more so when I saw a section dedicated to utilizing “new immigrant” talent for diversity purposes, only to find in cliché statements such as multilingualism and knowledge
Medical Devices
Health Canada’s Annual Regulatory and Quality Conference: A personal digest
In a recent LinkedIn post, I spoke about Health Canada’s plan to make the REP (Regulatory Enrolment Process) mandatory 18 months after its projected implementation date (January 2024). In another post, I summarized the list of proposed amendments to the Canadian Medical Device Regulation, for which
Medical Devices
Taiwan’s Health Tech success lies in Global South Collaboration
Even though Taiwan’s health tech has prevented the pandemic, MedTech regulations specialist Hasnaa points out that establishing a closer connection with the global south is the key to make Taiwan a leader in innovation of health tech.
Medical Devices
EU-MDR workshop
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EU MDR
Post-Brexit Medical Device Regulations
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EU MDR