A Complex Process Results in Long Lead Times for Market Access
Manufacturers of medical products who want to export their devices to China need to consider the local requirements for product certification and registration. These requirements are created and published by the Chinese authority, the China Food and Drug Administration (CFDA). Prior to 2013, the institution was known as State Food and Drug Administration (SFDA). The regulatory system relies on provisions issued by the Chinese State Council, on CFDA orders and normative CFDA documents that provide detailed guidelines for medical device registration and licensing practices. With hundreds of departments and divisions, the CFDA is a huge and powerful administration body based in Beijing. It carries out certification processes of drugs, medical devices and food with a wide range of responsibilities.
One of CFDA’s main tasks is to regularly update the catalogue of medical products requiring registration. Currently more than 700 devices are listed in the database and the list grows longer every year.
For manufacturers of medical devices, it is often difficult to find out whether their products require a CFDA registration for the Chinese market. Unfortunately, all of the standards and requirements are available only in the Chinese language. In addition, contacting the CFDA directly does not always result in a correct, definitive answer. Therefore, the criteria to determine need for CFDA registration can be complicated.
CFDA – A Colorful Past
Several scandals at the CFDA, including corruption and fraud at the highest levels, caused extensive reorganizational changes in 2003, 2008 and 2013. The most publicized and well-known was the scandal involving the CFDA’s Chairman Zheng Xiaoyu. For years, he reportedly took bribes in exchange for circumventing product testing of medical products. According to the Chinese news agency Xinhua, Zheng received an estimated 6.5 million Chinese Yuan (about $850,000.00 USD at the time) in bribes and other illegal inducements.
During Zheng’s leadership of the SFDA, hundreds of medical devices and drugs were approved for the Chinese market without passing the necessary administrative procedures and, more importantly, testing and clinical trials. As a result, many of the products approved were connected with consumer injuries and even deaths. The most notorious examples included unsafe eggs and milk products that reportedly resulted in the deaths of as many as 1000 people. Ultimately, Zheng’s greed cost him his life. The Chinese government made an example of this case, accusing Zheng of being a danger to both China and China’s reputation, and sentencing him to death.
Unfortunately, even with the threat of severe penalties, more scandals followed. In 2013 the SFDA changed its name to the CFDA and management given to the State Council of the People’s Republic of China. That same year Zhang Young was named the new director of the newly formed CFDA. The restructuring and rebranding were meant to increase accountability and to give the organization a fresh start.
The CFDA Approval Process
In the past, some medical products required China Compulsory Certification (typically referred to as CCC certification). However, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) changed this policy and no longer requires CCC certification for certain product groups (e.g., ECG devices, artificial heart-lung machines). For manufacturers, this facilitates their research for necessary product certifications for China.
The first step manufacturers need to manage is to clearly identify whether CFDA approval and/or other certification is necessary for exporting their product to China. Without any support or contacts with the Chinese authority, this can difficult. If the medical device is determined to require CFDA approval, the applicant needs to classify his product into Class I, Class II or Class III. This is another challenge for the manufacturer, because the CFDA product catalogues and corresponding instructions are only available in the Chinese language.
The criteria for classification into Class I, Class II or Class III are based on the European Union’s (EU’s) Medical Device Directive (MDD), 93/42/EEC. The higher the potential risk of a medical product, the more stringent the security and performance requirements. Class I devices can get CFDA registration by passing simple administrative procedures. This is a relatively quick process and typically takes about six months. For more complicated Class II and Class III products, long-term product testing and clinical trials may be required. Further, the clear distinction between Class IIa and IIb devices in the EU’s MDD does not exist within the Chinese regulatory framework. Only CFDA can draw the line between the middle hazard classes, estimate the potential product risk and determine the necessary approval process.
After all completed application and supporting documents have been submitted to CFDA, the authority will either confirm the applicant’s classification or correct it. Submitting all of the requested application documents does not automatically mean that the product can obtain CFDA registration. Only after acceptance of the application will the CFDA determine whether registration of the medical device is possible. Once registration is deemed possible, the CFDA will then prescribe the necessary certification process including tests and, if needed clinical trials.
If testing is prescribed for Class II and Class III products, it must typically be conducted by an accredited testing laboratory located in China. Test reports issued by foreign testing laboratories are generally not accepted. In rare instances, the CFDA will permit some testing to be performed outside of China. However, such testing is only permitted on a case-by-case basis, and is not even considered until after the CFDA has evaluated the initially application for registration and determined the terms of the registration process.
Communication between the applicant, testing laboratories and CFDA is crucial for the success of the certification process. The authority frequently changes the requirements for the approval process mid-stream, and can request additional documents and/or test reports throughout the process. These requests are often time sensitive, and delays in complying with them can halt progress or complicate the coordination of the approval process.
Only after laboratory testing has been successfully completed can clinical trials begin (if needed). Depending on the product, clinical trials typically last six to nine months or longer. After all test reports and clinical trial records are available, it can take up to additional six months for the CFDA to fully evaluated the results and issue their own report. The CFDA report is usually a comprehensive technical and administrative review. Based on the conclusions presented in the CFDA’s report, the device will finally receive approval for licensing, certification
Revised Regulations for The CFDA Approval Process
The CFDA frequently publishes new regulations and standards for the certification and registration of drugs and medical devices for China’s market. In 2013 and 2014, numerous legislative changes were published, including two that potentially signify significant changes for CFDA applicants and certificate holders.
At the beginning of 2014, the CFDA published on its website a revised version of “The Regulations for the Supervision and Administration of Medical Devices.” The revision includes a crucial change regarding the definition of medical devices that may affect the need for certification in general. Some products may no longer be considered medical devices, and therefore may not need CFDA approval. On the other hand, devices that were previously not considered to need CFDA approval may now be required to have it.
The CFDA notice also identified adjustments to device classification criteria. Like the changes in definition of medical devices, the revision of classification criteria may have a deep impact for applicants of CFDA certification. Required approval procedures may change in the future, due to the upcoming revisions. Depending on how a device or product is reclassified, the amount and degree of testing may increase or decrease, potentially requiring clinical trials where only simple laboratory testing was previously required.
104 New Chinese Industry Standards
In October 2013, the CFDA announced the introduction of 104 new standards that came into effect October 2014. At present, most of these new standards are not mandatory. However, they may become required in the future, and regulatory changes in China often occur with little or no advanced notice.
Chinese Industry Norms are abbreviated with
“YY” and define the scope, parameters and prescriptive measures for product testing required for registration of medical products and devices by the CFDA. The YY Standards apply when there is no corresponding Chinese GB Standard (GB stands for Guobiao, the Chinese term for “National Standard”) for the product. Therefore, GB Standards supersede YY Standards.
China’s YY standards, as well as other regulations and standards that affect CFDA approval and registration of medical products, are typically based on international standards such as those of the International Electrotechnical Commission (IEC). However, China’s standard many include national deviations from international requirements that must be considered in meeting technical requirements.
At the beginning of 2015, there were even more updates. On its website, the CFDA announced “Guiding Opinions on Enhancing the Construction of Food and Drug Inspection and Testing System.” As of this writing, there are no official interpretations of these Guiding Opinions, and applicants for CFDA registration and certificate holders are still evaluating their implications. Nonetheless, the Guiding Opinions are likely to affect the CFDA’s registration and certification process in the near future.
CFDA approval and registration is a time-consuming and labor-intensive process, and differences in language, culture, and time zones can make the whole process overwhelming. But once CFDA registration is granted, the medical product or device can be freely imported and sold throughout China. The opportunity is massive with China being one of the fastest growing markets for medical devices worldwide. With their growing economy, China is seeking to replace outdated medical equipment with world class, state-of-the-art technologies.
The medical device market in China has shown significant growth in the past years. For example, according to the China Pharmaceutical Industry Association, the industry output value increased by 20.2% in 2013 and reached 2.3 trillion Chinese Renminbi. For 2014, the Nanfang Research Institute for Pharmaceutical Industry, an institution that is associated with the CFDA, projected an output of even 2.7 trillion Chinese Renminbi, an annual growth rate of 19.7% over 2013.
For manufacturers of medical devices, there is even more good news. According to the China Association for Medical Devices Industry (CAMDI), more than 60% of the equipment in China’s medical facilities is on the technological level of the 1980s or older. There is a massive sale potential that is waiting to be tapped!
Julian Busch is director of MPR GmbH – China Certification Corporation, a company that supports manufacturers’ worldwide obtaining product certifications for the Chinese market. He can be reached at firstname.lastname@example.org.