Navigating the Muddy Waters of Chinese Device Regulations

China has witnessed a bevy of changes to device regulations over the past couple of years. So what should devicemakers keep in mind to avoid running afoul of regulations?

One way to avoid hiccups is to preplan, according to John Balzano, special counsel at Covington and Burling. This planning goes beyond just taking steps to get a license for bringing the product to market; devicemakers must plan on updating their licenses, distributing their products, getting their items priced and moving them to hospitals.

Many companies fail to plan for these additional steps, focusing solely on obtaining a license to market the device. However, Balzano noted during a recent FDAnews webinar that it is important to consider a host of issues, such as whether the device will be manufactured in China.

Panoply of Documents

Balzano noted that the China Food and Drug Administration has issued a number of guidances over the last year, and understanding the finer points of those guidances “can influence whether your application gets accepted or rejected at the filing stage, or whether the reviewers at the Center for Medical Device Evaluation are going to have to come back to you and ask you for supplementary materials,” Balzano said.

On top of these guidances and recent reforms, devicemakers also should be mindful of the various Chinese medical device standards. Balzano notes that the central government has made it a priority this year to cut down on the number of standards as they have become outdated and could lead to inconsistencies if multiple standards were used.

One area that regulators haven’t really touched is combination products. There is no combination product license; rather, sponsors submit their applications, and the CFDA determines whether it should be reviewed as a drug or device.

The use of foreign clinical trial data also is a murky issue, as the agency hasn’t articulated a well-formulated opinion on the topic. Typically, the agency decides on a case-by-case basis, and sponsors should inquire ahead of time about whether the data will be acceptable or whether local trials will be required.

Looking to the future, Balzano thinks industry could see legislation related to good clinical practices, as well as the finalization of adverse event regulations. A number of smaller regulations are in the offing, but industry should expect larger structural changes.

Finally, devicemakers should keep advertising laws front and center. Balzano expects more agency action in this area, with more crackdowns. “We’ve even seen enforcement against social media postings that people think qualify as advertisements,” he warned. Penalties can be substantial — in excess of $1 million — for advertisements deemed misleading. — Elizabeth Hollis