Late last year, the US and China held their 27th annual Joint Commission on Commerce and Trade (JCCT) meetings in Washington, DC. The US and China are the world’s two largest economies and are key trading partners. China has the second largest pharmaceutical market and the third largest medical device market in the world. The US is the largest supplier of medical devices to China. Therefore, it is important for the US and China to ensure economic prosperity through business with each other. During the meetings, the US and China agreed on new commitments, and focused on implementing past JCCT agreements.
The US and China agreed to continue the following for medical devices and pharmaceuticals:
- China will encourage domestic medical device development, but will also not discriminate against foreign products. China will also promote collaborative efforts in medical device development.
- China has already released some clinical trial exemptions for Class II and Class III medical devices that will be registered in China. They will continue developing clinical trial exemption lists and will consider key industry leader opinions during the process.
- China will continue to improve the drug registration and approval process.
The US and China also agreed to these new provisions concerning medical devices and pharmaceuticals:
- Currently, it may be difficult for the CFDA to obtain relevant updated information about a foreign company, which often delays review. The US and China agreed during the JCCT meetings to establish a form of communication to help with verifying this information.
- In 2015, China announced amendments to medical device classification rules, resulting in the downgrade of many medical device classifications. China will continue working on these amendments and re-classifications.