Japan has always been a good orphan drug market with high reimbursement and oftentimes government financial support for development. However, in the past, it was not flexible on designation unless 3 criteria were met – 1. the drug had to treat fewer... Read More
Everyone knows China is a big medical market. Many large and small healthcare companies are still doing well there. However, for a variety of reasons, the China opportunity is tougher to capitalize on today. For medical devices, China’s policy – Buy China... Read More
On January 1, India’s Central Drugs Standard Control Organization (CDSCO) put forth a new NSWS program and portal to help monitor and administer healthcare products that it regulates. Drugs, medical devices, and other healthcare products that require product registrations, import/export licenses, control... Read More
Late last year, Hong Kong’s Medical Device Department made public Technical Reference TR – 007. The guidance defines and classifies Software in a Medical Device (SIMD) and Software as a Medical Device (SAMD). SIMD is used for medical purposes and controls or... Read More
As discussed in our recent news briefs, Japan is initiating a number of regulations to improve its drug market including increasing novel drug reimbursement, expediting its fast-track approval system further (Sakigake), etc. In late December, the Japanese government issued a report that will... Read More
During the last year, we have outlined the steps the PMDA is taking to expedite registration for Software as a Medical Device (SaMD). Besides expanding its SaMD review staff and offering more SaMD consultation sessions, the PMDA presented on January 22nd in... Read More
Last month the Thai FDA promulgated that the medical device application pre-screening time would be reduced from 30 days to 1 day. In addition, the time to review Class 2-4 device applications would decrease from 200 days to 120 days if an expert... Read More
According to a recent announcement by Korea’s Ministry of Food and Drug Safety (MFDS), AI medical devices with reduced risks can be registered without the MFDS’ clinical trial requirement. In addition, for other AI medical devices that do require a local clinical... Read More
On December 22, 2023, Hong Kong’s government issued a new update (GN-10) to its Medical Device Administrative Control System (MDACS). It is the Hong Kong local agent‘s job (local responsible person or LRP) to report product registration changes and update the MDACS.... Read More
On November 27, 2023, Taiwan issued an amendment to the – Regulations Governing Issuance of Medical Device License, Listing, and Annual Declaration. Medical device registration in Taiwan includes two separate applications – 1. a dossier on the product and 2. a Quality... Read More