China Medical Device and Pharmaceutical Regulations

China Medical Device and Pharmaceutical RegulationsThe China 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 and drug. 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, conducts medical device adverse events monitoring and reevaluation, and handles issues related to the manufacturing and distribution of devices within China. The Department of Drug and Cosmetics Registration conducts registration for pharmaceutical products, optimizes registration and licensing procedures, and monitors drug non-clinical and clinical studies.

Medical Device Classification System in China

China’s medical device classification system shares some similarities with U.S. and European standards. Under the China medical device regulations, devices can be categorized into Class I, Class II, and Class III devices. 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.

Drug Classification System in China

Under China’s classification system for pharmaceuticals, drugs can be classified as three types: Chemical Drugs, Biological Drugs, and Traditional Chinese Medicine/Natural Drugs. Within the Chemical Drugs class, drugs can be further categorized into Innovative New Drugs, Improved New Drugs, Generic Drugs, Domestic Generic Drugs, and Imported Drugs.

China Medical Device and Pharmaceutical Regulatory Updates

On October 8, 2017, China’s State Council proposed new regulations for drugs and devices. Although these regulations have not yet taken affect as laws, the proposed changes include:

  • Acceptance of foreign clinical trial data for drugs and devices, which should reduce the need for local clinical trials in China. The global trials must be conducted at multiple centers and the data must meet the CFDA’s regulatory standards.
  • Removal of the certification system for medical institutions certified to conduct clinical trials; instead, manufacturers will be responsible for recruiting third parties to conduct trials.
  • Optimization of the review and approval process for product registrations by establishing a centralized dossier system, a panel review system, and more efficient communication channels.
  • Implementation of a Marketing Authorization Holder (MAH) system, which will require manufacturers to appoint a marketing authorization holder to be responsible for pre- and post-approval activities during all major aspects of the product life cycle.
  • Strengthening of intellectual property (IP) protection, to address the severe IP theft issue amongst Chinese manufacturers.

Going forward, there will also be an overhaul of the organization of China’s food and drug authorities. In March 2018, China’s National People’s Congress approved plans for the China Food and Drug Administration (CFDA) to be merged into a newly formed National Market Supervision Administration. A new State Drug Administration under the merged ministry will be responsible for overseeing drug approvals.

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

 

China Medical Device and Pharmaceutical Regulatory Resources

China Medical Device & IVD Regulatory Webcast

China Medical Device & IVD Regulatory WebcastThe comprehensive China Medical Device & IVD Regulatory Webcast provides in-depth information on China’s medical device and IVD regulations, and the 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.

China Regulatory and Market Access Pharmaceutical Report

China Regulatory and Market Access Pharmaceutical ReportThe China Regulatory and Market Access Pharmaceutical Report covers the registration and market access process for pharmaceutical products in China. The report gives a thorough overview of the Chinese regulations governing drug registration, pricing, R&D, manufacturing, sales, and marketing, including clinical trials, GMP, reimbursement, provincial bidding, hospital tenders, and more. Read the report to learn about how to optimize the process to increase sales in China.

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