While China’s device market is still growing in double digits, several factors have made it harder for foreign companies to succeed there. China wants to make more of its own devices and export them to the rest of the world. The Chinese... Read More
Starting on March 1st, 2023, China’s Provisions on the Supervision and Administration of Drug Market Authorization Holder Implementation of the Main Responsibilities of Drug Quality Safety, was implemented. The goal of these provisions is to require drug market authorization holders (MAHs) to... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
If your company wants to enter the Japanese market and is interested in our DMAH service, contact us today for a free consultation. Currently the third largest medical device market in the world, Japan presents many opportunities for foreign medical device companies. However, only... Read More
Contact us today for a free consultation with our Japan DMF expert. Currently the third-largest pharmaceutical market in the world, Japan presents many opportunities for foreign drug companies. Major factors such as a rising incidence of chronic diseases and a rapidly aging population... Read More
Qualified research institutions that develop their own pharmaceuticals will be eligible to hold marketing authorization permits in China under new legal guidance that went into effect in late September. Since 2015, when China first began implementing its Marketing Authorization Holder (MAH) system,... Read More
Introduction to China’s Drug Market Everyone has been talking about opportunities in China’s drug market the last 5 years. While the size of the drug market in China varies, we estimate it at about $140 billion dollars now and growing about 10%... Read More
Changes to pharmaceutical registration regulations in China that went into effect July 1 make clear that Market Authorization Holders designated by the country’s regulatory authority to market or distribute a product are responsible for the safety, quality, and efficacy of that product... Read More
This article was also published on MedTech Intelligence. All medical device companies that are interested in the Japanese medical market need to determine the most effective way to either enter Japan or expand their presence there. However, Western device executives often try... Read More
在日本没有分部的外国生产商必须委任一家上市许可持有商（以下简称MAH）或一家上市许可持有代理商（以下简称dMAH）来管理医疗器械注册事宜并与日本药品和医疗器械综合管理机构（PMDA）进行沟通。 Read More