In order to strengthen the supervision and management of medical device production, standardise the quality management of medical device production, according to the ‘supervision and management regulations of medical devices’ (State Council Decree No. 650), ‘supervision and management of the production of medical devices’ (State Food and Drug Administration Decree No. 7), the State Food and Drug Administration revised the ‘Code for the Quality Management of Medical Device Production’.

QSR 820 system counselling in the United States, BGMP system counselling in Brazil, JGMP system counselling in Japan, KGMP system counselling in Korea, UKCA QMS system counselling in the United Kingdom, FDA factory inspection counselling in the United States; and medical device system counselling in other countries.

MDSAP, Medical Device Single Audit Program MDSAP is a third party audit and assessment programme developed by the IMDRF organisation in 2014 to improve the safety and surveillance of medical devices for trade, resources and services. The aim is to achieve uniform recognition among different MDSAP member countries (TGA Australia, ANVISA Brazil, FDA USA, HC Canada, MHLW & PMDA Japan) through a single audit process.

ISO13485 in Chinese is called ‘medical device quality management system for regulatory requirements’ As medical devices are special products to save lives, prevent diseases and cure diseases, it is not enough to regulate them only according to the general requirements of ISO9000 standard, for this reason, ISO organisation has issued the standard of ISO13485:1996 (YY/T0287 and YY/T0288) to put forward special requirements for the quality management system of medical device manufacturers to achieve safety and effectiveness. T0287 and YY/T0288), which puts forward special requirements for the quality management system of medical device manufacturers and plays a good role in promoting the quality of medical devices to be safe and effective.
The executive version from November 2017 till now is ISO13485:2016 ‘Requirements for the use of quality management systems for medical devices for regulatory purposes’. The name and content have been changed compared to the previous version.