China's making progress with its quality management system regulations.

During summer's hot days, certain manufacturers in China were feeling the heat in a different way. Poisonous ingredients were found in both cough syrup and toothpaste manufactured in China, and toy giant Mattel issued a recall of nine million of its toys made in China after the company determined paint on the products contained lead, which can be toxic. Meanwhile, the medical community had its own reasons to feel jittery with the execution of the former head of the State Food and Drug Administration (SFDA) and arrests of other high-level officials in healthcare and regulatory agencies due to bribery and mismanagement. The leadership changes and shuffling of personnel within the SFDA and local agencies left many bewildered as to the SFDA's future direction.

For those of us in the regulatory arena, while frustrated with the indecision and slow pace of the agency on many crucial issues, we were happy to see increased attention paid to regulatory compliance and emphasis on quality management by top leaders in the government. China is not ignorant of the concept of quality control, and standards have been in place for some time now--one can find a small inspection card or sticker attached to each product on the market, indicating that the product has been examined by an inspector prior to shipment. However, the overall management system for quality, which has been the guiding principle of many successful companies in the rest of the world, has been fairly new to Chinese businesses. The medical device industry's rapid growth has left little time for Chinese companies to focus on such fundamental infrastructure of a business. Chasing orders and filling them quickly, coupled with greed and corruption, have been the driving forces for many "successes'--and blunders--of several manufacturers.

A Look at China's Quality Management

China does have an official industry standard for quality management. Released in 2003, Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes (YY/T 0287-2003) was simply a Chinese translation of ISO 13485. Because the language in this standard is quite general, though, the implementation requirements for self-examination by manufacturers and onsite inspection by SFDA officials have been very generic as well.

Manufacturers passed quality system inspections if they passed all major check items and most minor items. Due to the lack of specificities, though, companies could pass these inspections quite easily, leaving room for problems to surface down the line.

To strengthen quality system management, the SFDA has launched several programs since 2005 focusing specifically on high-risk Class III products, such as orthopedic implants, cardiac catheters and stents. In 2006, the agency launched a separate quality program focused on manufacturers of implantable and sterile products. The program included 51 of 110 implant and sterile product manufacturers, which received inspections of their quality system management. The chosen companies must follow a set of newly drafted guidelines on quality management. Code for Quality Management System of Medical Device Manufacturers (which is still in a trial phase) was drafted and released in 2006 for use during this program.

Chapters of this newer regulatory document include the following topics:

* General provision

* Management responsibilities

* Resource management

* Documents and records

* Design and development

* Purchasing

* Production management

* Supervision and measurement

* Sales and service

* Control of failed products

* Customer complaint and adverse incident monitoring

* Analysis and Improvement

Besides this top-level general guideline document, two additional regulations specifically have been designed for manufacturers of sterile and implantable products, respectively. To facilitate a smooth inspection process, the SFDA also released the associated codes (or checklists) for these manufacturers and SFDA inspectors. Manufacturers of implantable products are faced with 313 checklist items--40 of which are key inspection items with which manufacturers must demonstrate compliance. Manufacturers of sterile products need to satisfy 275 check items--37 of which are the key items. Besides the basic requirements listed in the general document, there also are specific requirements governing clean room setup and operation, sterilization inspection and batch release criteria. These additional requirements were de rived from other related national standards for implantable and sterile products. Compared with the previous version, this set of documents is more detailed and precise while remaining quite comprehensive.

The quality system management program for sterile and implantable product manufacturers commenced in December 2006 and was projected to close sometime around May this year. The final report on the results of this program has not been released by the SFDA yet. Although the regulations have been in a trial phase to test the program's accuracy and suitability, the rumor circulating is that they will officially be released by the end of this year. Therefore, companies that are not in full compliance with these regulations must act quickly to improve their management and processes in product quality management.

Other Quality-Related Initiatives

Looking back at the past year of quality initiatives, it seems prudent to provide an update on continuing programs in China.

In the November/December 2006 issue of Medical Product Outsourcing, this column reported that random quality inspections of products on the market were being conducted by the SFDA. This program is still in effect and continues to generate reports on various products.

In an effort to improve product quality and help amend the reputation of Chinese products in international markets, China's State Council, the top economic management agency, issued a document, titled Special Requirements to improve Safety and Supervision of Food and Other Products, on July 26. This document is aimed at strengthening safety regulations for food, drugs and medical devices. The notification, although lacking specific details, signals the central government's determination to correct past practices and install internationally acceptable business practices across the food and drug, as well as medical device, industries.

Besides the national programs, regional food and drug administration agencies have launched various programs to inspect medical device manufacturers and distributions. Registration documents of Class II and Class III products were reviewed for accuracy and truthfulness.

Other state agencies are stepping up to manage product quality as well. The Administration of Quality Supervision Inspection and Quarantine issued a new regulation in June about inspection of imported medical products. As of press time, the detailed implementation guidelines were expected to be released in October, with the official implementation set to begin Dec. 1.

It is clear to everyone that China needs to work on its product quality for the benefits of its own citizens and international customers. Watching the developments and activities by the SFDA and other agencies, the direction is set toward better control and quality. The slowdown in market growth in the coming years also may provide a much-needed breathing time for companies to focus and realign their priorities.

Let's hope that, in the future, none of our colleagues and companies will have to deal with the situation facing Mattel right now.

Chang-Hong Whitney is president of Whitney Consulting Ltd. in Massachusetts. With an MBA from Babson College (Wellesley, MA) and undergraduate degrees in electronic engineering and international business, she has been consulting for western companies on doing business in China since 1994, focusing on the medical device market. Her services include China regulatory affairs, market research, sourcing and logistics programs and China business strategies. She can be reached at [e-mail].