China’s economy is growing rapidly, and so are standards of production. As its manufacturers continue to develop more sophisticated processes and products, quality standards are increasing dramatically. Medical devices are no exception. China’s medical device market has grown to $6 billion, the second largest in Asia after Japan. From 2004 to 2005, the number of device manufacturers grew by thousands. Capacity is growing both for exporting abroad and manufacturing for China’s domestic market. More standards, national and industrial, are becoming required. While these standards help Chinese sources achieve higher degrees of quality and standardization, they can also present pitfalls. This article briefly describes device GMP and QA regulations and practices in China, as well as recent and coming changes to the system.
Regulatory Bodies and Official Standards
China’s national regulatory body responsible for medical device registration in China is the State Food and Drug Administration (SFDA). It is broadly responsible for the registration and safety surveillance of pharmaceuticals, medical devices, and health foods. It has a large number of provincial and local branches. Also, the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) formulates national quality standards.
Chinese national standards can be recognized by their different designations. Those starting with GB are national standards, those starting with YY are medical industry standards, and those starting with ZCB are product registration standards. If they also include a T (GB/T, YY/T), they are just recommended, not compulsory. They tend to have matching international standards. For example, GB9706.1-1995 is the national standard for medical electronic equipment, identical to IEC60601.1:1988.
Inspection and Licensing of Medical Device Manufacturers
According to the Provisions on Supervision and Administration of Medical Device Manufacturing, all medical device manufacturers must receive a Medical Device Manufacturing Enterprise License in order to get their medical devices registered. (Because even class I products must be registered in China, this applies to virtually all device manufacturers.) Inspectors check items such as product quality, manufacturing conditions, labeling and packaging, and quality control and assurance. However, these are not yet carried out according to most international standards.
Quality System Audits
For manufacturers of class II and III products, quality system inspections are required. These inspections are done partly by manufacturer self-assessment forms, similar to Western self-assessments, and partly by on-site confirmation of the submitted documents. These audits do not impose mandatory standards, but the recommended standards are GB/T19001 and YY/T0287 (ISO 9001 and 13485). Once a site has passed its audit, the results are applicable to all medical devices in the same class for the next 5 years.
Daily Supervision of Medical Device Manufacturing
The SFDA and provincial and local departments can also do inspections of device manufacturers who have already been licensed. This is essentially on their own discretion. Daily supervision can cover product quality, quality systems, or other areas.
General Quality Supervision
To keep general tabs on overall device quality, the government carries out a national program of sampling and testing of device quality. This was recently codified by the Requirements for National Sampling and Testing of Medical Device Quality (Interim), though it has gone on for some years. In this sampling, provincial food and drug departments will choose various products to sample, and then send requests for samples to various device manufacturers, distributors, and medical institutions. At the request of the government, the samples need to be sent to a designated Testing Center, with supporting documentation. The Testing Center will do product quality testing on its own premises. This sampling can be the basis for further investigation, requirements for corrective action, recalls, or even revoking of product registration. Since it samples distributors and hospitals, it can also affect imported medical devices, but it is mostly geared toward domestic products.
GMP Implementation – Now and Future
Medical device GMP regulations in China are undergoing a steady ramp-up in implementation. The target is full mandatory Chinese GMP compliance for class II and III devices within 5 years. This will be implemented as part of the quality system audits described above.
Currently GMP (according to YY/T0287-2003, identical to ISO 13485:2003) is non-compulsory. The implementation is proceeding by category of device. It started recently with the promulgation of specific requirements for sterile medical devices and implantable medical devices. In 2007, new manufacturers of those devices will need GMP compliant inspections to receive their Medical Device Manufacturing Enterprise License. This will extend to all manufacturers of those devices by 2008. There are three more stages planned over the next four years. In each stage a new group of devices will receive new standards, until all class II and III devices have been included. These new standards will necessitate a shakeup of China’s domestic device industry, with significant new investment to upgrade facilities becoming necessary to stay in business. A similar process has already occurred with pharmaceutical GMP, which became mandatory in 2004. At the end of this process, the Chinese device industry should be even more reliable and competitive in the world market.
China has developed a system of quality certification referred to as the China Medical Device Quality Certification, or CMD. The SFDA and AQSIQ have set up a unitary center for administering and testing, the China Quality Certification Center for Medical Devices (CMDC). It is not compulsory yet, but only recommended for class III devices.
There is also the China Compulsory Certificate, or CCC. China is implementing this system as part of an effort toward general standardization. At the moment it is only compulsory for seven types of medical devices, including electrocardiographs and hemodialysis equipment, but this is likely to expand in the future.
Increasing Post-Market Vigilance
China has been developing a national system for medical device adverse event monitoring (AEM) since 2005. There is a network of AEM institutions at the provincial level, and manufacturers, distributors, hospitals, and the general public can make reports to them. The AEM institutions then report their findings to the SFDA.
In recent years, the Chinese government has taken more and more action on devices as a result of adverse events. In 2005, they ordered recalls of 11 devices, including some produced by foreign companies.
Quality Assurance with Chinese Suppliers
Although the capability of the Chinese device industry is high, it is also extremely variable, so close vetting of quality is crucial, both before a deal and during its implementation. It is common practice to implement outside quality monitoring of a contract manufacturer, either with your own employees or with third parties working on site full-time. Even with high-quality manufacturers, changes are often necessary to achieve compliance with FDA standards, because China tends to rely on ISO and European standards.
Quality conditions in China are on an ever-upward trajectory, as more and more capabilities enter the realm of possibility every year. At the same time, enhanced inspections and the need for application of new standards may lead to critical delays to bring products to market. Foreign companies on the ground will need to make a constant effort to keep their partners up with the pace of improvement.
Ames Gross – President and founder. Mr. Gross is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross founded PBM in 1988 and has helped over 200 medical companies with business development and regulatory issues in Asia.
John Minot – Associate. Mr. Minot graduated with a B.A. in Government and East Asian Studies from Cornell University. He works on research and writing projects and speaks Japanese.