Starting May 1, the China National Supervision Administration updated the 2014 Measures on the Supervision and Administration of Medical Devices Manufacturing. These measures put in effect more rigorous regulatory manufacturing requirements and increased the responsibilities of medical device manufacturers and third-party OEMs. While... Read More
This article was first published on MedTech Intelligence. Everyone knows China has a large medical device market. Over the last 30 years and up until a few years ago, opportunities for device sales in China were good for many Western device companies.... 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
Plans by China to create a free trade port in Hainan province, which have moved forward swiftly this year, bolster opportunities for the growth of the country’s pharmaceutical industry. They are also likely to lower prices on imports for Chinese consumers who... Read More
Advanced Therapy Products (ATPs) will be subject to tighter regulation in Hong Kong under an ordinance passed by the legislative council of the special administrative region of China. The ordinance, expected to go into effect next year, requires facilities to obtain a... Read More
New requirements issued in May mandate that pharmaceuticals produced in Indonesia contain at least 30% or more raw materials that are domestically produced. The requirements from the Indonesian Ministry of Industry have been in development for months and have yet to be... Read More
Driven by the urgent need to develop more and better ventilators and other devices to treat Covid-19 patients, South Korea plans to bolster private-sector medical device research in the country with an infusion of government cash and expertise. The research and development... Read More
China’s National Medical Products Administration (NMPA) is seeking public comments on new regulations it is drafting on drug registration, drug distribution, and manufacturing. The new regulations, updated in October by the Ministry of Justice, reflect changes made to the Drug Administration Law... Read More
Spiraling trade tensions between the U.S. and China are injecting uncertainty into what was already a complex environment for MedTech manufacturers. Accelerating steps, some medical technology firms have already been starting to move their operations to other countries in the region. Directly... Read More
Four years after China established a pilot program enabling drug license holders to use third parties to manufacture their products, the National Medical Products Administration in August launched a database to allow drug makers and the public to more easily access information... Read More