Conditional drug approval in China can be granted if the drug meets certain criteria – 1. it helps patients more than approved therapies, 2. has the same efficacy as existing drugs but has fewer side effects, 3. can help with a public... Read More
The PMDA has released a list of new medical devices approved from April to September 2022. This updated list was published on the PMDA website on December 28, 2022. Please click on the link below for details. 000249403.pdf (pmda.go.jp) This latest version... Read More
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More
Late last year, Vietnam’s MOH issued a draft letter addressing device registration. First, Class C and D device applications will now be submitted initially to Conformity Assessment Bodies (CABs) starting on September 1, 2023. Certificates from CABs will go into effect on... Read More
Due to the relaxation of China’s zero COVID policy and government investment in Chinese hospitals, the demand for medical devices in China should grow in 2023. With more Chinese getting COVID now, Chinese hospitals are seeing a dramatic rise in equipment needs.... Read More
Over the last 3 years, many AI healthcare products have been approved in the West. However, this has not been the case in Japan. AI healthcare approvals in Japan have been difficult to obtain and experienced a very slow approval process. Given... Read More
In late October, the Chinese CDE outlined a strong recommendation for the review of clinical trials in China before they occur. In the past, the CDE mentioned the need for clinical trial sponsors to consult with them but recently, this recommendation has... Read More
In our May newsletter, we mentioned that in July, Japan would start allowing online submissions. At that time, online submissions of new drugs, new medical devices, improved medical devices with clinical data, IVDs for new products, and IVDs with clinical data were acceptable. Now, as of... Read More
Cybersecurity risks are now heightened by medical devices which are connected via the Internet and Intranet in hospitals and home networks. The Cybersecurity Agency Scheme for Medical Devices rates each device according to its cybersecurity risk. This scheme includes four designations of... Read More
Technical testing is an integral component of the medical device registration process in China. In October 2022, the China NMPA announced that the new Chinese standard related to the safety of electric medical devices – BG 9706.1-2020 – will come into effect on... Read More