Our company is committed to providing clients with end-to-end consulting services and regulatory support for drug registration in China until approval from National Medical Products Administration (NMPA).

Proregulations is excited to announce its participation in the 29th CBA Annual Conference, which will be held at the Marriott Washingtonian Center (9751 Washingtonian Blvd, Gaithersburg, MD 20878), on June 9, 2024, 07:45 am - 5:30 pm. About CBA The Chinese Biopharmaceutical Association (CBA), founded in 1995, is an independent, non-political, non-profit professional organization with more than 700 active members and 100 institutional members. As a biopharma organization that gathers industry elites and shares cutting-edge wisdom, CBA aims to promote scientific research, technology development and commercial cooperation in the field of biomedicine. The CBA Annual Conference is its signature event, attracting thousands of scientists, entrepreneurs, policy makers and industry leaders from around the world each year, and is one of the largest annual gatherings of the biopharmaceutical industry between the United States and China. For further information on CBA, please visit cba-usa.org

People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device which is on the market. Proregulations provides a range of U.S. medical device 510(k) premarket notification services to help customers reach their goal of selling in the U.S. market as quickly as possible.

Our company provides comprehensive services for the approval of your medical device to enter the North American market, which include regulatory consultation, determination of classification, submission of applications, etc. We are committed to avoiding registration risk and saving time.