Our Voices

IP and General Legal Issues in the MedTech Industry in China

By Holly Y. Li

Regulatory Framework

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:

  • The Center for Medical Device Evaluation (CMDE): responsible for conducting the dossier review during the medical device registration process.
  • The General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ): conducts mandatory safety registration, certification, and inspection for certain devices.

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:

Data Privacy and Protection

  1. Consumer health and personal data:
  2. Health improvement outcomes and cost-effective data:

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.

Intellectual Property (IP) protection

IP issues abound in China. Again, each situation requires the right expertise. Questions such as:

  1. What areas of IP law afford the best protection for MedTech?
  2. Does patent law provide an effective protection mechanism preventing infringement and misappropriation of your technology?
  3. Is there a requirement to transfer ownership of IP rights to a state-owned Chinese company in order to do business with it?
  4. How to prevent cyber-attack in a country where many of the best hackers reside?
  5. What is the current state of the affairs for encryption technologies in China?

Choice of Law and Jurisdiction

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.

  1. Where should this MedTech company file its patent application, China or the US?
  2. Is the extension technology developed in China or the US?
  3. Do you need a foreign filing license to file an application in either country?
  4. When enforcing in China, which city or province should you file your IP infringement lawsuit, given that there are numerous IP courts being established in China in the recent years?

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.

Holly Y. Li
Ross Epstein
Wei Zhang