Clinical trials: studies of the absorption, distribution, metabolism and excretion of relevant drugs under controlled artificial conditions, using specific diseased or healthy populations as subjects, with the aim of discovering and confirming the effectiveness and safety of interventions for the treatment, prevention or diagnosis of specific diseases, as well as for confirming their effectiveness and safety
In clinical trials, the preliminary preparations generally include protocol development, preparation of trial materials, identification of study centres, and adequate training.
Coaching for the QSR 820 system in the United States, BGMP system in Brazil, JGMP system in Japan, KGMP system in South Korea, UKCA QMS system in the United Kingdom, and FDA factory inspection in the United States; as well as coaching for medical device systems 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.
To strengthen the supervision and management of medical device production and standardize the quality management of medical device production, the China Food and Drug Administration (CFDA) has organized the revision of the "Quality Management Standards for Medical Device Production" in accordance with the "Regulations on the Supervision and Administration of Medical Devices" (Decree No. 650 of the State Council) and the "Measures for the Supervision and Administration of Medical Device Production" (Decree No. 7 of the CFDA).
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