- What are the norms for setting up a medical device factory in China?
Good Manufacturing Practice for Medical Devices and YY0287-2017-Medical Devices-Quality Management Systems-Requirements for regulatory purposes / ISO 13485:2016 need to be followed.
- What is the current situation of centralized procurement of medical consumables?
In March 2018, China changed the National Health and Family Planning Commission to the National Health Commission, and the National Healthcare Security Administration established later is in charge of centralized procurement. Currently, there are ten modes of centralized procurement of medical consumables.
- What is the two-invoice system?
It refers to two invoices: one invoice is made out when pharmaceutical products are sold from the factory or importer to primary dealers, and the other invoice is made out when pharmaceutical products are sold from dealers to hospitals, so as to replace the seven or eight invoices commonly seen currently with two invoices. The two-invoice system will change the current problems of excessive circulation links of drugs and price increase layer-by-layer, and alleviate the public’s pain caused by the high cost of medical treatment.
- What is the implementation status of China’s medical device GDP system?
In the Guideline for the Management announced on September 22, 2016, it is stipulated that medical devices always meet the temperature requirement as indicated in the instructions for use and labels of medical devices in the process of transportation and storage by the medical device manufacturer, distributor and the user.