China Updates Medical Device Trial Guidelines

By Jof Enriquez,
Follow me on Twitter @jofenriq

The Chinese Food and Drug Administration (CFDA) released new medical device clinical trial guidelines for sponsors intending to launch devices in China. It's the first update to the country's device trial guidance in 12 years.

In the document, CFDA covered general principles of device trials for registration studies intended for obtaining regulatory approvals, as well as preparation criteria, informed consent, clinical trial protocols, and management of study device and source documents. The update does not cover in vitro diagnostic reagents that are classified as medical devices.

Law firm Ropes & Gray outlined the salient contents of the revised guidance, titled Good Clinical Practice for Medical Devices (“Device GCP”), which will go into effect on June 1, 2016.

• Clarifies the definition of "sponsor" to be a device manufacturer, instead of the applicant who submits the device registration application, and requiring a foreign sponsor to designate a Chinese company as its agent.
• Puts additional responsibilities on sponsors, such as requiring them to appoint qualified monitors, and, if needed, revise the investigator brochure and obtain approval from the ethics committee for said revision.
• Requires the study device to pass a registration-type test conducted by a qualified testing center.
• Defines a "multicenter study" as a study conducted according to a single protocol, but at more than three sites, and requires the ethics committee of the lead site to conduct an ethics review of the protocol on behalf of all study sites.
• Requires the study sites to keep all clinical data and materials for ten years after completion of the clinical trial.
• Reaffirms the current regulation stipulating that sponsors file for the recordation of their device studies with local FDAs, at the provincial level, prior to launching any studies.

According to RAPS, CFDA worked on the revised guidance with the National Health and Family Planning Commission of China (NHFPC), resulting in a lengthy document that covers 96 specific points across 11 chapters. In comparison, the current text, which was introduced in 2004, features 29 specific points across 7 chapters.

The Chinese government has invested over RMB $2.2 trillion (USD $359 billion) in the past five years to improve China’s medical device regulations and harmonize them with regulations used overseas, such as in the U.S., Japan, and the European Union (EU), explains John Pong, a market research analyst at Decision Resources Group (Hong Kong).

The updated guidance brings much-needed clarity and consistency in government regulation helpful for both domestic Chinese medical device manufacturers and foreign device companies, especially as the Chinese healthcare market continues to expand.

As China's role as an exporter of medical products grows, the United States Food and Drug Administration (FDA) has strengthened its relationship with Chinese regulators. Among many initiatives, FDA has trained hundreds of Chinese inspectors in areas that include inspecting for good manufacturing practices and assessing the quality of data from sites that conduct clinical trials.

"These investments will pay long-term dividends for the American people: a stronger Chinese regulatory system can only strengthen FDA’s efforts to promote and protect U.S. public health," wrote Christopher Hickey, Ph.D., FDA Country Director for the People’s Republic of China, in a previous blog post.