RAPS Webcast: Japan 2023 Medical Device Regulatory Update
The recording of the webcast can be accessed here. Read More
The recording of the webcast can be accessed here. Read More
Recently, China has shifted towards electronic submissions in an effort to expedite the review and approval process for drugs. At the end of November 2022, the China NMPA announced that starting January 1, 2023, all drug registration applications as well as supplementary information need... Read More
Japan has been very apprehensive about the so-called “drug loss” for its citizens. Many new foreign biotech companies seem to be declining Japan’s entrance due to limited reimbursement pricing mechanisms for expensive new products, especially for drugs for children, rare, and intractable... Read More
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
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
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