The Korean Ministry of Food and Drug Safety (MFDS) published a draft amendment to the Medical Device Act that mandates a new Management System for Controlling Medical Device Information (MCMI) to record information on the overall life cycle of the medical devices from manufacturing to end-use.
Any company applying for new or renewal KGMP certificates after July 1, 2019 will be subject to several new requirements. This change has the potential to add significant time and cost to the compliance requirements for manufacturers that employ multiple outsourced manufacturing facilities.
US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
The South Korean regulator, the Ministry of Food and Drug Safety (MDFS), recently released multiple guidance documents related to software using AI, Big Data and Machine Learning.
Korea’s Ministry of Food and Drug Safety (MFDS) recently published final revisions regarding importing non-registered medical devices under special circumstances, including for research and personal use only, scarce or urgently needed, to be used by a Korean laboratory, clinical trials and/or orphan products.
The Korean government has announced intentions to increase the official fees charged by the Ministry of Food and Drug Safety (MFDS) and Medical Device Information and Technology Assistance Center (MDITAC) for processing medical device conformity assessment applications.
The Korean government increased fees charged by the Ministry of Food and Drug Safety (MFDS) and Medical Device Information and Technology Assistance Center (MDITAC) for processing medical device conformity assessment applications in May of 2017. Fees are now US$1,000 for a Safety and Efficacy Review (SER) and US$500 for a Substantial Equivalent (SE) review. Processing fees for a device license amendment will be increased to US$700 for an SER device and US$400 for an SE device.
Official fees for Class 2 technical document review and KGMP certification will maintain at the same level, but the official fees for Class 1 devices and for minor changes will increase slightly (by US$3/application).