New Industry Standards Recently Released

Along with new technology comes a host of new standards to ensure products remain safe and effective. On April 25, the State Food and Drug Administration of China (SFDA) published 73 new technical standards for various medical devices. These technical guidelines and requirements pertain to specific products such as X-ray or ultrasound equipment, as well as implantable cardiac catheters.

The technical standards typically stipulate the technical parameters or requirements that a device must meet or satisfy. There are mandatory standards that a device must meet to be approved by the SFDA, and there are recommended standards, which manufacturers can comply with (or not) at their own discretion. 

Typically jointly drafted by technical experts from SFDA testing centers and chief engineers of leading manufacturers in the industry (under the coordination and supervision of the agency’s Standard Department), the standards are product specific and often are referred to as “industry standards.” Over the years, the SFDA has continued publishing and revising standards to keep them current with the advancing technology level in China. Many of the recently published standards are new to the industry, but some are updates to existing standards. Of all these standards, 30 are mandatory (ie, device manufacturers must comply with them), while the remaining 43 are recommended. 

Among the 30 mandatory standards, the newly established ones pertain to dental implants and dental materials; ophthalmology scopes; radiation treatment software; blood purification system; breast implants; and safety requirements for in-vitro diagnostic instruments. Updated standards pertain to devices such as lithotripters, cardiac implants, dialysis tubing, endoscopes, MRI, electrocardiogram machinery and gastric lavage machines.

Among the recommended standards, there are more new standards than updated ones. The newer standards include information areas such as specific bio-compounds for bio-engineering products; general requirements for surgical implantable products; special requirements for heart and blood vessel implants and stents; and in-vitro diagnostic instruments (such as automatic chemistry analyzers, blood analyzers and coagulation analyzers). Two major standards among the newly revised ones are the biocompatibility evaluation for dental equipment and risk management in application of medical devices.

All of the newly published mandatory standards will go into effect on Dec. 1, 2009, while the recommended standards will be implemented on June 1, 2009.