Registration of Class IIa Medical Device for Gastroesophageal Reflux at the Department of Health in Hanoi, Vietnam The Department of Health in Hanoi, Vietnam officially registered our Class IIa medical device. Additionally, it’s important to note that the device holds an MDD certificate extension. The device is an oral emulsion composed of key actives: low…
Extension of MDD Certificate for Our Medical Devices for the Treatment of Gastroesophageal Reflux Disease (GERD) Based on Alginates The MDR regulation, effective from May 2017 and applicable from May 2021, governs medical devices in Europe. Deadline extensions allow the marketing of devices compliant with the Medical Devices Directive (MDD) until December 31, 2027, for…
Legacy Devices: Guidance on significant changes according to the EU Medical Device Regulation (MDR) 2017/745 Article 120, paragraph 3, of the EU Medical Devices Regulation (MDR) 2017/745, amended by the latest Regulation (EU) 2023/607, states that devices that remain compliant with the AIMDD or MDD can be placed on the market until December 31, 2027,…