China's medical device makers will implement a standardized quality management system, according to an announcement from China's State  Food  and Drug Administration (SFDA) yesterday.

The SFDA will promote a series of production management regulations on a trial basis. The trials will first be made on 22 sterile medical device manufacturers in Shanghai and the provinces of Zhejiang, Guangdong, Shaanxi. Also 29 mimplanted medical device manufactures in  Beijing, Jiangsu Province, Sichuan Province and Tianjin will take part.

Ten products will be involved, including blood bags, syringes, plasma separators, cardiac pacemakers and inter-uterine devices.

The quality  management  system  will cover company resource management, documents  and records, design and development, purchase and production, surveillance  and  measurement,  sales procedures, nonconforming product controls, and adverse event monitoring.

The SFDA said it would request that local drug administrations make on-site inspections on manufacturers from January to April, with the SFDA making a summary next May.

Source:佚名