Chang-Hong Whitney10.15.07
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 derived 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.