In the previous column, we discussed China’s fast track approval process for innovative medical devices and how products can qualify under a new guideline issued in December 2016. Here we will explain how China’s regulatory system is structured and discuss the China Food and Drug Administration’s (CFDA) approach to medical devices.
China’s State Council is the chief administrative authority in the country. Under it is the CFDA, which is the national authority for food and drugs, includes the Department of Medical Device Supervision, and is responsible for registration of medical devices for the Chinese market. However, each Chinese province has its own food and drug authority, and it is the provincial authorities, not the national authority, that have oversight of Class I and Class II medical devices.
Medtech is heavily regulated in China, but the Quality Management System (QMS) and Good Manufacturing Practices (GMP) requirements only date back to the 2000s, with major updates in 2009, 2013 and 2014. Compared to the established U. S. regulatory system, the Chinese regulatory system is in a growth phase, though developing into a comprehensive regulatory entity.
With its development comes a lot of regulatory activity. The CDFA released 71 documents related to medical devices in 2016, including 19 decrees, 6 working reports, and 46 guidelines. Under China’s centralized government, all of the CFDA’s dictates are definitive and mandatory, whether they come in the form of a decree or a working report.
Of the many regulatory actions that impact the medtech industry, and medical devices in particular, the CFDA takes a specific interest in sterile devices, implants, and in vitro diagnostic medical devices (IVDs). These devices are targeted for inspection and scrutiny because of their high-risk impact and invasive nature. As a result, these devices have well-defined requirements and are often subject to onsite inspection to ensure quality and compliance.
While the CFDA follows International Organization of Standardizations (ISO) standards, it may follow an older version of the ISO standard. For medical devices, China follows ISO 13485, but it follows the 2003 version, not the 2016 revised version. As a result, requirements are different, which impacts regulatory action in China. For example, under the China GMP there are more inspections. To be compliant with the CFDA, it’s very important to understand the regulatory standards differences and the impact they can have on product manufacturing and testing in China, which in turn can impact an approval schedule.
Another example of regulatory differences between China and other countries is evident with regard to a 510(k) premarket submission. In the U.S., there is no requirement for an onsite inspection with a 510(k). However, in China, if a domestic manufacturer wants to register a new product, an onsite inspection is required.
More detailed standards of production, manufacturing, and quality systems started to be introduced in 2009, but actual supervision and monitoring from CFDA was very weak. In February 2014, the State Council issued Medical Device Supervision and Administration Regulation (State Council #650), which went into effect on June 2014. The CFDA also issued a series of new regulations, guidelines, and updates for medical devices. GMP is one of the key areas, with more than 18 regulations providing direction, to date.
To summarize, a clear understanding of China’s regulatory development and compliance standards used in the medical device manufacturing market is important to the commercialization process and meeting timelines. China’s revised GMP and overseas on-site inspections and domestic unannounced inspections call for manufacturers to be more diligent and to make sure they are in compliance with the proper regulations.
Note: For additional information on regulatory changes, see Grace Fu Palma’s FDAnews webinar titled China Medical Device Regulatory Changes that was broadcast on January 31, 2017. See details here: www.fdanews.com/chinamdregulatorychanges.