China Primer: GMP and QA for Medical Devices

Thinking of Doing Business in China or Just Need to Brush Up on Your Knowledge? Your Education Starts Here

Ames Gross and John Minot

China’s economy is growing rapidly, as are standards of production.  In turn, quality standards are increasing dramatically as manufacturers there continue to develop more sophisticated processes and products.

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.

Along with this trend, more standards—national and industrial—are becoming required. While these standards help Chinese sources achieve higher degrees of quality and standardization, they also can present pitfalls. Following is a primer on GMP and quality assurance (QA) regulations and practices in China, as well as some information on 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).  This agency, which has a large number of provincial and local branches, is broadly responsible for the registration and safety surveillance of pharmaceuticals, medical devices and health foods.

Another agency of interest is the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), which 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
•    Those starting with “ZCB” are product registration standards
•    If they also include a “T” (eg, GB/T, YY/T), they are  recommendations, not compulsory standards.

Many of China’s standards 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 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 products registered. (Because even Class I products must be registered in China, this applies to virtually all device manufacturers.) Inspectors check factors such as product quality, manufacturing conditions, labeling and packaging, as well as 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 (similar to 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 five years.

Daily Supervision of Manufacturing

The SFDA as well as provincial and local departments also can conduct inspections of device manufacturers who already have been licensed.  These types of inspections essentially are performed at the agencies’ 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 has in place a national program for the sampling and testing of device quality.  This was recently codified by the Requirements for National Sampling and Testing of Medical Device Quality (Interim), but it has been in operation for several years. Through this program, provincial food and drug departments select 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 (and supporting documentation) must be sent to a designated testing center. The center then will perform product quality testing on its own premises. Results of this sampling can be the basis for further investigation, requirements for corrective action, recalls or even revoking of product registration.

It should be noted that since distributors and hospitals are not immune to being selected for sampling requests, imported medical devices also can be affected, but this program mostly is geared toward domestic (Chinese) 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 five 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.

The implementation 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 requirement will then extend to all manufacturers of those devices by 2008.

Three more stages additionally are 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 a significant new investment to upgrade facilities becoming necessary to stay in business. A similar process already has 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.

Quality Certification

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, called the China Quality Certification Center for Medical Devices. This system, which is not yet compulsory, currently is only recommended for Class III devices.

In addition, there also is the China Compulsory Certificate. 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. A network of AEM institutions exists at the provincial level, and manufacturers, distributors, hospitals and the general public can provide reports to them. The AEM institutions then report their findings to the SFDA.

In recent years, the Chinese government has taken much more action on devices as a result of adverse-event reporting. In 2005, recalls were ordered for 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; thus, 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 often are necessary to achieve compliance with FDA standards, because China tends to rely on ISO and European standards.

In conclusion, quality conditions in China are on an ever-upward trajectory, as 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 in bringing 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 is president and founder of Pacific Bridge Medical, a Bethesda, MD-based consultant firm that helps companies doing business in the Asia market. A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988 and has helped more than 200 medical companies with business development and regulatory issues in Asia.
John Minot is an associate with Pacific Bridge Medical. A graduate with a BA in Government and East Asian Studies from Cornell University, he is fluent in Japanese and works on research and writing projects.