On April 22, the NMPA‘s Center for Medical Device Evaluation (CMDE) and the Hainan Medical Product Administration (MPA) announced the Hainan Communication Standard Operating Procedure (SOP) for Medical Device Clinical Real-World Data Applications. This announcement details the regulatory process to register non-approved... Read More
Starting May 1, the China National Supervision Administration updated the 2014 Measures on the Supervision and Administration of Medical Devices Manufacturing. These measures put in effect more rigorous regulatory manufacturing requirements and increased the responsibilities of medical device manufacturers and third-party OEMs. While... Read More
Contact us to learn about how we can help you in the Chinese MedTech market. This article was first published on MedTech Intelligence. Everyone knows China has a large medical device market. Over the last 30 years and up until a few... Read More
In the past, hospitals made money in China by marketing up drugs, devices, procedures, and doing many diagnostic tests. Those days are over. As mentioned in our previous newsletters, China’s Volume Based Procurement (VBP) has cut the reimbursements for many high priced... Read More
Last summer, the Japanese MHLW issued guidelines saying the PMDA and the prefectural authorities should do surprise GMP inspections on factories that have had many previous problems. The surprise GMP inspections were to stop factories from covering up sensitive issues before inspections.... Read More
On March 21, 2022, China’s Ministry of Science and Technology (MOST) released the draft version of the Implementing Rules for Human Genetic Resources Management to seek public opinion by late April. The release of this document signals the Chinese authorities’ intention to help facilitate clinical... Read More
On March 31, the Japanese MHLW issued a notification allowing CDxs in Japan to be used for more than one drug, in addition to the initial treatments they were originally approved for. In the past, different CDxs were available for unique drugs... Read More
In an effort to accelerate the medical device registration process, the Taiwan Food and Drug Administration (TFDA) has launched in January the TFDA Medical Device Pre-Market E-Submission System, which enables manufacturers to submit documents for their pre-market applications and renew licenses digitally. The new online... Read More
Singapore’s Health Science Authority (HSA) recently announced regulatory updates pertaining to the two Special Access Routes GN-26 and GN-27. GN-26 allows licensed healthcare providers to import unregistered medical devices to use on their patients. GN-27 allows licensed importers to import unregistered medical... Read More
The China NMPA recently announced that the updated China Good Clinical Practice (GCP) for Medical Devices will come into effect on May 1, 2022. The GCP was promulgated in 2016 in order to ensure the quality of medical device clinical trial management,... Read More