A list of recently published and updated articles regarding medical device regulatory updates from the MFDS and other governing bodies in South Korea.

Medical Device Advertising Requirements in Asia

In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.

How New EU MDR Requirements Will Affect Registrations in Asia

As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.

Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.

Korea MFDS Implements Medical Device Monthly Reporting Requirements

The Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.

South Korea Releases Guidance for Software using Big Data, AI, and Machine Learning

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.

GUIDANCE ISSUED FOR IMPORTING UNREGISTERED MEDICAL DEVICES INTO KOREA

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.

MEDICAL DEVICES SHIPMENTS DURING THE COVID-19 PANDEMIC

COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.

4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

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.

KOREA CHANGES MEDICAL DEVICE QUALITY SYSTEM REQUIREMENTS

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.

Korea Intends to Increase Medical Device Registration Fees in 2017

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.