The August 2019 edition of Global Regulatory Press’ Journal of Medical Device Regulation  features a Vietnam overview authored by two of Tilleke & Gibbins’ regulatory affair specialists in the jurisdiction—Hien Thi Thu Vu, head of the regulatory affairs team in Vietnam, and Mai Thi Le, regulatory affairs consultant in Vietnam. Their in-depth overview provides an insider’s perspective into the regulatory world

• Market Overview: Locally manufactured medical devices vs. imported devices, and expanding medical device regulationsa
• Legislative Framework: List of relevant legislation regulating medical devices
• Regulatory Controls: Manufacturing and trading requirements, medical device registration and classifications, medical device importation, and advertising
• Labeling and Language: List of compulsory content for medical device labels, and language specifications
• Clinical Trials: Requirements for conducting clinical trials and expected timeline
• Vigilance and Post-Market Surveillance: Traceability, and medical devices that cause of harm of post serious threats
• Future Developments: Expected upsurge in competition as demand grows from increasing average life expectancy

To read the full Vietnam overview, please visit the Global Regulatory press website, or follow the link to the PDF below.

The regional Tilleke & Gibbins team also authored the Thailand overview for the Journal of Medical Device Regulation .

Reproduced with the kind permission of Global Regulatory Press from the Journal of Medical Device Regulation, 2019, 16(3), 35-47 (http://www.globalregulatorypress.com/).