This past summer, Korea issued article 43-6 of the Medical Device Act, requiring medical device manufacturers and importers to obtain liability insurance for patient claims of injury or death. For now, only manufacturers or importers of implantable device products are required to... Read More
International KGMP biopharmaceutical inspections were halted in Korea in early 2021 because of the COVID-19 pandemic. However, in September, the Ministry of Food and Drug Safety (MFDS) announced that they will proceed with these KGMP inspections in 2023. Since there is now... Read More
Following quicker approval times for biopharmaceuticals in Korea, the Ministry of Food and Drug Safety (MFDS) will review and plan to expedite registration for innovative medical devices. Various government departments and medical institutions will determine within 30 days if the device meets... Read More
The Korean government plans to increase Korea’s drug and biotechnology markets by adopting more global standards, implementing positive regulatory policies, and increasing investment. The Korean government hopes to develop a super fund to support its vaccine and new drug development. First, Korea... Read More
A recent report from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association criticizes the government for continuing to lower drug prices in Korea which hinders the growth of new drug development. The report claims that this government policy only incentivizes drug companies to... Read More
Due to the COVID-19 pandemic several years ago, the Korean Ministry of Food and Drug Safety (MFDS) stopped its on-site inspections of drug maker’s foreign manufacturing plants. In March 2022 however, the Ministry announced that it was going to resume in-person inspections... Read More
The government of South Korea is beginning to offer insurance reimbursement for the use of several ultra high-priced drugs, a development that could be both lucrative for pharmaceutical companies and provide relief to Korean consumers. Pharmaceutical treatments, under review by Korea’s Health... Read More
Contact us today for a free consultation with an Asia regulatory affairs consultant to discuss your specific needs. This article was originally published on MedTech Intelligence. 3-D printing has revolutionized product customization and digital manufacturing in various industries. In many instances, it... Read More
As interest has grown in Korea in the rapidly developing applications of medical software to diagnose, treat, cure or prevent disease, regulators have increasingly turned their attention to digital healthcare, particularly Software as a Medical Device (SaMD) technologies. With clinical trials of... Read More
As the use of digital therapeutic technologies (DTx) grows in Korea, investment in the technologies is on the rise, and government regulators are taking a closer look at how to evaluate and ensure the safety and performance of the products. In December,... Read More