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The recording of the webcast can be accessed here. Read More

On December 12, 2022, the Ministry of Food and Drug Safety (MFDS) announced that they will resume KGMP on-site audits starting on January 1, 2023, for all Class 2, 3, and 4 devices for registration approvals in Korea. Over the COVID period,... 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

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