Oct 22, 2018
By Holly Y. Li
Today, along with digital revolution, medical device and pharmaceutical companies have revolutionized the medical and health industry. These revolutions have saved or improved the quality of lives tremendously. Along with such social and economical progress, US, European and China lawmakers and regulatory agencies have also been making systematic changes in the legal and regulatory system to address the concerns in the market place. In China, the Chinese regulatory body, China Food and Drug Administration (CFDA), presides over the registration and licensing system for Medical Devices. The Chinese registration process tends to be long and difficult for foreign device and pharmaceutical companies. In addition to CFDA, the following agencies also are involved in the registration and licensing process:
In China, working with an agent who is well versed in the CFDA process is the only practical way to navigate through them.
Regulatory approval for a medical device is one aspect of the commercialization process in China. Other legal issues can be more worrisome for MedTech companies. The following are concerns that have been increasing in importance in recent months and years:
Ownership of this valuable data remains unsettled. Whether a patient/consumer or the company who developed the data collecting device or technology depends on each unique factual pattern which must be carefully analyzed before a determination can be made.
IP issues abound in China. Again, each situation requires the right expertise. Questions such as:
If a US MedTech company distributes a medical device developed in China and collects data from local consumers to further develop its devices, what impact does that locally collected data have on important strategic questions.
In summary, doing business in China is a challenge on many fronts. Working with experts in these fields is the only way one can successfully navigate Chinse business. CKR Law is a global firm with local expertise including boots on the ground in China to help with cross-border transactions and other legal issues as they arise. Please do not hesitate to contact any of the attorneys listed below with questions or concerns for your medical device issues in China.