Dr. Atthachai Homhuan, manager of regulatory affairs at Tilleke & Gibbins, recently contributed the Thailand overview for the May 2019 edition of Global Regulatory Press’ Journal of Medical Device Regulation —an industry-specific journal that provides an insider’s perspective into the regulatory world surrounding medical devices in jurisdictions around the world.
In the Thailand overview, Dr. Atthachai covers the following topics:
- Introduction: Growth of medical devices through technology, and improvement of local regulations
- Legislative Framework: Overview of relevant legislation regulating medical devices
- Regulatory Controls: Definition, classifications, and advertising
- Vigilance Requirements: Reporting duties for defective products or adverse effects
- Post-Marketing Surveillance: Annual reporting duties, site inspections, and advertisement and label monitoring
- Clinical Trials: Adherence to the Good Clinical Practice guidelines (ICH-GCP)
- Labeling and Language: Requirements for language and content on medical device labels
- Future Changes: ASEAN Medical Device Directive, a new classification system underway, proposed implementation of the Good Distribution Practice, and effects of Thailand’s Personal Data Protection Act
To read the full Thailand overview, please visit the Global Regulatory Press website, or follow the link to the PDF below.
Reproduced with the kind permission of Global Regulatory Press from the Journal of Medical Device Regulation, 2019, 16(2), 28-41 (www.globalregulatorypress.com ).