The People’s Republic of China, a communist nation in East Asia, is the world’s most populous country. While it accounts for 20% of the world’s population, it consumes only 1.5% of the global drug market! As more of its citizens are acquiring health insurance, the pharmaceutical and medical device industries are expected to undergo major growth.
On November 23rd, 2015, the U.S. Department of Commerce released its Fact Sheet on the 26th U.S.-China Joint Commission on Commerce and Trade. The fact sheet spelled out great news for U.S. Pharmaceutical and Medical Device industries regarding regulatory requirements for entering the Chinese market. Here is what the fact sheet stated:
PHARMACEUTICALS AND MEDICAL DEVICES
According to industry data, the U.S. pharmaceuticals industry directly employs more than 810,000 workers, supports a total of 3.4 million jobs in the United States, and provides annual compensation to its workers at approximately twice the average for all U.S. workers. China is the second largest market for pharmaceuticals in the world, with the size of its market being estimated at $83 billion in 2013. Exports of U.S. medical devices to China reached over $3 billion in 2014. According to industry data, the U.S. medical device industry includes over 7,000 companies, most with less than 100 employees, and supports 1.9 million U.S. jobs overall. Cutting red tape in China’s medical device approval process, as China has committed to do below, will allow better patient outcomes in, and more exports to, China, the industry’s largest growth market.
Pharmaceuticals and Medical Devices Registration and Approval
The United States and China affirm:
- That China publishes annual reports on drugs and medical devices evaluation that include their performance efforts.
- That in 2014 and 2015, China issued clinical trial exemption catalogues for Class II and Class III medical devices and the Medical Device Clinical Trial Evaluation Guidelines, and will conduct relevant training. In 2016, China will complete the drafting of the second batch of medical device clinical trial exemption catalogues in order to further expand the scope of the exemption catalogues.
- That China is currently refining mechanisms to communicate with registration applicants. For innovative medical devices, the China Food and Drug Administration (CFDA) will appoint dedicated personnel in the evaluation and approval process to provide guidance and promptly communicate with the applicant upon request. For other types of medical device registration applications, relevant departments of the CFDA will conduct weekly group consultations for applicants.
- That the State Council Opinions on Reforming the Review and Approval Systems for Drugs and Medical Devices (State Council 2015 No. 44) is the guideline for reforming China’s drug and medical device review and approval systems. China agrees that the CFDA will provide no less than a 30-day public comment period for implementing departmental rules and regulations, and will also abide by its technical barriers to trade (TBT) commitments.
In accordance with China’s medical device regulatory legal framework, China agrees that in the area of market access, it will give imported medical devices the same treatment as those manufactured or developed domestically.
Are you ready to take your pharmaceutical products and medical devices to China? If so, why take unnecessary risk? Read our white paper 5 Case Studies in Medical Translation & Localization, or register to attend the 15 minute free webinar.
You may also contact GlobalVision for a complementary professional consultation.