Medical network - July 21, to strengthen the supervision and administration of medical devices clinical trials, according to the implementation of supervision and spot check medical instrument clinical trial in 2017 notice "(the state food and drug administration bureau in 2017, no. 103) clear selectiving examination scope and relevant principles, the state food and drug administration and extracting the microwave therapy apparatus (1600084) accepted number: CQZ 10 registration items, such as to the authenticity of the clinical trial data and compliance to implement supervision and inspection on site. The acceptance number of the application, the name of the product, the applicant and the clinical trial shall bear the appendix. The examination and inspection center of the food and drug administration of the state administration of food and drug administration shall be notified separately by the state food and drug administration. 

 

Hereby notify. 

 

Attachment: the first batch of clinical trial supervision of medical devices in 2017