China Medical Device Regulations

China Medical Device RegulationsChina’s Food and Drug Administration (CFDA) is the administrative body responsible for the regulation of medical devices and pharmaceuticals on the Chinese mainland. The CFDA is separated into various departments that are individually responsible for the registration, tracking, and monitoring of medical devices. The Department of Medical Device Registration conducts registration for Class III devices, optimizes control procedures, organizes and implements classification administration, and supervises the implementation of best practices. The Department of Medical Device Supervision tracks and analyzes existing problems with medical devices, recommends system modifications, and conducts medical device adverse events monitoring and reevaluation. The Department of Medical Device Supervision also handles issues related to the manufacturing and distribution of devices within China.

Classification System

China’s medical device classification system shares some similarities with U.S. and European standards. Under the China medical device regulations, Class I devices are simple devices that can be effectively monitored through regular administration while Class III devices are complex implants or life supporting devices. Medical Device Classification rules were issued in State Drug Administration’s Order Number 15. The Center for Medical Device Evaluation (CMDE) is responsible for reviewing relevant documents during the registration process.

Regulatory Framework

The current China medical device regulations were originally implemented on April 1, 2000. Key provisions of the CFDA’s regulatory framework include:

  • The CFDA is responsible for supervising the manufacturing and distribution of medical devices nationwide. Local governments at the county level and above are also responsible for monitoring medical devices within their respective provinces and regions.
  • China actively encourages the development of “new medical devices.” New Class II and Class III medical devices can only undergo medical trials after receiving approval from relevant authorities.
  • Medical device registrations are valid for four years. Certificate holders must apply for re-registration within six months of the expiration date.
  • Provisions for the clinical trials of medical devices can be found in the State Food and Drug Administration’s Order Number 5.

Regulatory Updates

In 2014, China’s Food and Drug Administration updated several key provisions of its regulatory framework. Important updates that affect medical device distributors and manufacturers include:

  • Class I medical devices no longer required registration. Rather than register a Class I device, manufacturers must file a notification with the local Chinese FDA office.
  • Certain Class II and III devices must undergo clinical trials. The CFDA significantly improved this process by releasing a clinical trial exemption list for certain devices.
  • In-vitro diagnostics must undergo a testing process before they can enter the clinical trial period.
  • Certain new fees were introduced that manufacturers and distributors must pay. Penalties for non-compliance have also increased.
  • The regulations implemented new requirements related to good manufacturing practices and good supply practices.

Manufacturing

New guidelines for manufacturing medical devices took effect on October 1, 2015. These new guidelines were created in an effort to facilitate the supervision and management of medical devices, improve quality assurance processes, and better ensure the safety and compliance of all medical devices. These regulations affect sterile medical devices, implantable medical devices, and in-vitro diagnosis reagents.

The CFDA also regularly conducts surprise inspections of medical device manufacturers in an effort to enforce compliance with industry standards and improve device safety.

Foreign manufacturers that export medical devices to China need to hire local agents to act as their representatives during the registration process. Manufacturers must have a local agent on hand to deal with adverse events as well as handle support and communication.

 

For more detailed information about registration requirements and the regulatory pathway for medical devices in China, please see Medical Device Registration in China.

 

China Medical Device Regulatory Resources

China Medical Device Regulatory Webcast

China Medical Device RegulationsThe comprehensive China Medical Regulatory Updates 2015 Webcast provides the latest updates on China’s medical device and IVD regulations, and offers an in-depth look into the new product registration requirements and timelines. Other key topics include updated clinical trial and good supplier practice (GSP) requirements, re-registration, reimbursement, labeling, manufacturing site transfers, and more. View the webcast to gain expert insight into the new Chinese medical device regulations and best strategies to expedite product registration.

Medical Device Regulatory News from China

Pacific Bridge Medical releases timely news briefs on medical device regulatory affairs in Asia every month. Click here to view the latest updates on China medical device regulations.

For more free information and resources on the Asian medical device regulations and healthcare markets, please check out our Resource Center and Blog.