إجراء مقترح من تايلاند: الأجهزة الطبية

The Minister of Public Health hereby issues the draft notification on refurbished medical devices as follows: • Definitions of ‘Refurbished medical device’, ‘Product owner’ and ‘Authorized representative’ • Refurbished medical devices shall be refurbished by the product owner or its authorized representative. • Refurbished medical devices specified in the annex to the notification shall comply with IEC 63077, applicable quality management system requirements, including ISO 13485 (within the scope of refurbishment), and labeling requirements.