The Flanders-China Chamber of Commerce, in collaboration with Smart Hub Flemish Brabant and Flanders Investment & Trade, organized the Masterclass: “Understanding China's Healthcare sector”. The Chinese healthcare market is experiencing an unprecedented growth that is presenting burgeoning opportunities for Flemish companies. China is now the second largest market in the world for medical devices and pharmaceuticals. China’s healthcare service market is also quickly becoming one of the largest in the world.
Additional session on May 18, 2022: “Registration of Medical Devices in China”.
Ms Gwenn Sonck, Executive Director, Flanders-China Chamber of Commerce and EU-China Business Association, introduced the speaker, Mr John Balzano, Partner at Covington & Burling, who gave a presentation on how to successfully register your medical devices in China. Mr Balzano lives in New York, and in pre-Covid times used to travel frequently to the company's offices in Beijing and Shanghai. He is an expert on medical device registration in China, from the development through the approval for marketing.
China has revised his medical device framework regulation in 2021 and the main agency for regulating devices is the National Medical Products Administration (NMPA). Devices in China are divided into three classes, the higher risk devices are subject to higher requirements. China has two broad pathways: one for devices that are imported and one for domestically produced products. Mr Balzano explained the approvals, licenses or filings needed in each case. For some devices clinical trials in China are required. Your device will need to comply with Chinese mandatory standards and you need to check with your company's engineers whether you can meet them. The translation in Chinese of the product technical requirements needs to be perfect. China has several medical tourist zones such as the Hainan Bo'ao Medical Tourism Zone, where certain devices which have been approved abroad can be approved early. Materials for device registration or filing are the same but it is the level of review that is different. Once you get registered, you become a market authorization holder.
Members can obtain a copy of all sessions. If you are interested, please send your request to info@flanders-china.be
