China’s law (Implementing Regulations of the Drug Administrative Law) is currently being updated and out for public comments until June 9. The draft regulation includes over 181 articles or over 100 more articles than the current law. Some possible changes among other... Read More
On May 9, the MHLW issued a notice that they will accept online applications for drugs, medical devices, and regenerative medicine products. Other types of products that can be submitted online include applications for API master files, GCP/GPSP onsite inspections, and partial... Read More
On April 1, Malaysia’s Medical Device Authorities (MDA) issued a guidance document further classifying devices into 3 categories – 1. Non-invasive medical devices, 2. Invasive medical devices, and 3. Active medical devices. In addition to these categories, a number of new rules... Read More
As software as a medical device (SaMD) gains significant traction in Singapore, the HSA has recently issued Guidelines on the Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software. This guideline, which references the International Medical Device Regulatory Forum’s (IMDRF)... Read More
Historically, Japanese drug registration lagged approval in the West by a number of years. However, in the last 7 years or so, regulatory changes in Japan have expedited approval there. These changes include more drug reviewers, a simplified approval process, an updated... Read More
Japan is planning to establish a new system (Kin-kyu-sho-nin) in case of emergencies that will allow new drugs and devices to be urgently approved without going through an efficacy confirmation process. Under this new approval system, manufacturers of new drugs only need to provide existing... Read More
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
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 years ago, opportunities for device sales in China were good for many Western device companies.... 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