Japan has been slow to approve SaMDs but hopes to finalize its registration system for these products in 2024. On May 29, after a working group session that included the PMDA and Chuikyo (Japan’s reimbursement agency) to discuss SaMD registration, a guidance... Read More
Singapore’s HSA‘s last update on GN-14 was made in 2018. Now, a new draft was announced on May 2. This document outlines and revises the risk classification of IVD medical devices in Singapore. For example, IVD medical devices that recognize the existence... Read More
While LDTs have been used in the US for over 30 years, they have not been utilized in China. In 2021, China issued its first LDT regulations, but they were vague and led to uncertainty. Recently, China has issued some new regulations... Read More
To register devices in Malaysia, you must make a dossier submission according to the required items in the Medical Device Act of 2012, and the specific instructions outlined on the Malaysia Medical Device Authority (MDA) website. Starting May 1, the MDA changed... Read More
Before 2013, there were hundreds of clinical trials done in India that resulted in faulty data, lawsuits, and significant problems. From 2013 to 2019, the number of clinical trials in India dropped significantly. However, in 2019, India implemented New Drug and Clinical... Read More
In the past, Malaysia’s medical device authority (MDA) issued only paper physical Medical Device Registration Certificates. Starting May 2, the MDA started issuing registration certificates electronically. During the transition period from May 2 to December 31 this year, the MDA will issue... Read More
According to China’s Drug Administration Law, Chinese Marketing Authorization Holders (MAHs) have the right to outsource drug manufacturing to contract manufacturers. Recently, China issued a draft notice to MAHs to increase the quality of drugs made by third parties. Specifically, provincial NMPA... Read More
Last month, officials from Korea and the US issued a Memorandum of Cooperation (MoC) on AI used in medical and healthcare products. According to the MoC, the two countries will try and harmonize regulations on AI medical products. The Korean government also... Read More