Technical Standards and Testing Capabilities

Medical products made in China long have been required to comply with certain technical standards. There are national standards—typically mandatory—that mainly focus on product safety. In addition, there are standards that deal with specific products and their unique requirements in performance and specifications. This is called “industry technical standard” or “industry standard.” Industry standards can be mandatory or elective. Up to now, China has 169 national standards and 585 industry standards.

The rapid development of medical technology and the influx of state-of-the-art medical devices into the Chinese market have caused dramatic growth, but the existing industry standards have badly lagged behind. To alleviate this situation and catch up with the rest of the world, the SFDA issued an interim regulation on the drafting of technical standards for medical products in 2007. This regulation formalized the pro-cess on standard initiation, drafting, implementation, amendment filing and other general management procedures. It paved the way for systematic management of technical standards within the medical industries. Under this regulation, SFDA took the initial role in drafting the standard, but the official standards are released through the Standard Administration of China (www.sac.gov.cn).

Under this framework, technical standard committees for various products are set up to initiate and draft relevant standards. In 2008, 137 industry standards were issued, 40 percent of which were mandatory. China also has accelerated adoption of internationally accepted standards. Beginning in 2007, SFDA required all electronic medical products to comply with IEC 60601.1, the international standard for electrical safety of medical devices. Foreign products that have been tested in their countries of origin must be re-tested against the IEC equivalent Chinese safety standard (GB9706.1) before entering China. Other branches of IEC standards and ISO standards (such as ISO 10993 for biocompatibility) also have been adopted into the Chinese standard system. This year, SFDA will establish a medical device standard committee to expand the drafting of basic and general standards to strengthen evaluation standards for biological materials and related products. This committee also will finalize 93 industry standards for 16 types of medical products, such as in vitro diagnostic reagents, implantable products and external circulation products such as dialysis devices.

SFDA regulation requires that Class II and III products must go through type testing prior to premarket approval. However, many testing centers do not have a well-established infrastructure and sophisticated testing equipment to handle advanced technologies.

This year, SFDA is going to use funding from the central government to help testing centers expand their capabilities. Nine national-level testing centers will receive about $88 million to build new laboratories and purchase new testing equipment. Twenty-three provincial-level testing centers also will receive $37 million for equipment.