On May 19, Singapore’s Health Sciences Authority (HSA) started a public consultation on a proposed exemption to the existing regulatory requirements for Artificial Intelligence – Software as a Medical Device (AI-SaMD) that is developed in the public healthcare sector. Under the Health... Read More
This article was originally posted on MedTech Intellligence Oftentimes, obtaining the right medical device reimbursement in Japan is more important than both the expected need/demand for your product and medical device registration. Of course, all three things are important. However, if the... Read More
Registering a medical device in Korea involves navigating a stringent regulatory process governed by the Ministry of Food and Drug Safety (MFDS). While much has been written about Korea’s classification system and regulatory pathways, one critical aspect often overlooked is the documentation... Read More
Securing Korea Good Manufacturing Practice (KGMP) certification is a key regulatory milestone for medical device registration in Korea. The KGMP system, overseen by the Ministry of Food and Drug Safety (MFDS), ensures that medical devices are consistently produced and controlled according to... Read More
On May 14, 2025, the Japanese government amended the Pharmaceutical and Medical Device Act 2025. Prior to this update, the PMD Act only outlined the roles and responsibilities of the MAH’s key responsible people. It did not have any specific penalties or rules... Read More
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a substantial increase in unannounced inspections at foreign manufacturing facilities that manufacture medical products for U.S. import. This initiative is a result of a White House Executive Order directing agencies... Read More
In December of last year, we published a news brief explaining that Foreign Reference Pricing is becoming less important in Japan for device reimbursement. Today, Japan’s medical device reimbursement normally closely follows the reimbursement in Europe, not the US and Australia, which are... Read More
On May 13, China’s NMPA promulgated a new list of medical devices exempt from clinical trials. This new list, an update to the 2023 list, identifies 27 medical devices, including seven Class 3 products and 20 Class 2 products. In total, 1047 medical... Read More
As mentioned in our newsletter over the last 18 months, Japan is now taking a more aggressive posture to tackle the issue that many drugs in the West are not yet available in Japan. To help speed up the process, the MHLW has... Read More
Western drug companies are demanding improvements to Korea’s “Innovative Company” criteria. Up until now, the Korean government has been choosing innovative firms every two years. Since the program started, there have been 49 designated innovative drug companies, but only 4 of these were... Read More