What documents are required to file?

All documents submitted must be in both Chinese and English. Documents that are needed for registration can be grouped into three categories:

・Manufacturer's eligibility by the home country: this means the company's business license issued by the government, permissions by the healthcare and medical device regulatory agencies, etc.
・Product information: product standard, user's manual, permission to market from the home country's government agencies.
・Third party verifications - Type testing report or clinical trial report: SFDA request additional validation of the products by its authorized testing centers in China . Class II products need to have type testing reports issued by authorized testing centers. Class III products may need clinical trial reports. There are authorized hospitals who can perform clinical trials as well.

ecause CFDA constantly modifies its regulations, it is advisable to contact Whitney Consulting for more details. Lack of document or mistakes in document will only delay the process. Whitney emphasize on “doing it right the first time”.