Taiwan Medical Devices Act: Highlights and Challenges

About the webinar Hide

The Medical Device Act covers medical device tracking management, Good Distribution Practice (GDP) for medical devices, and online registration for low-risk medical devices.

The presentation will be conducted by Rolen Liu, a consultant from ERM Taiwan. Rolen is an expert in the medical device regulatory sector and has firsthand experience in handling regulatory registration-related cases. This session will be moderated by Maryann Sanders

Maryann will be moderator and Rolen will be speaking at this webinar.

ERM speakers and moderators Hide

Maryann Sanders

Technical Director, Scientist

Maryann leads multidisciplinary problem-solving teams to assist ERM clients in meeting their business goals through effective systems and process that allow them to meet regulatory requirements and customer expectations. Her work ranges from assisting clients in building and auditing global product stewardship programs to using her skills in toxicology, microbiology and regulatory affairs to help clients meet the needs of the value chain and the myriad of global regulatory requirements that impact them. Maryann is an active member of the Product Stewardship Society and an adjunct professor in the Master of Science in Product Stewardship program at Indiana University, where she teaches a course in regulatory affairs.

Rolen Liu

Consultant

Rolen Liu is a consultant who has over 8 years in the medical device, clinical trial, and pharma field with a pharmacy background and is based in ERM Taiwan. His expertise lies in medical device registration, coordinating device constituents of combination products, reviewing, and assembling for customer regulatory submissions (NDAs, INDs), reviewing post-approval supplements, including evaluation of documents for accuracy and conformance with reference to applicable regulations, as well as planning and executing registration strategies to meet initiatives and timeline.

ERM Contact Hide

ERM Contact

For further information please contact, Parishrut Tripathi at Parishrut.Tripathi@erm.com