Advanced Biomedical Technologies Achieves ISO Equivalent in China
Advanced Biomedical Technologies Inc. (ABT) has gained the Chinese regulatory seal of approval for its quality management system (QMS) in its Shenzhen manufacturing location. The Chinese State Food and Drug Administration (SFDA) certified that ABT met the YY/T 0287-2003 standard, which is the Chinese equivalent to the ISO 13485:2003. The Eagan, Minn.-based company’s primary product line includes internal fixation devices (bone screws, pins, wires, etc.) consisting of proprietary high grade polymers which allow the body to degrade the products during the healing process.
According to SFDA regulations, all Mainland Chinese medical device manufacturers must document, implement, and maintain a QMS. Only manufacturers with an SFDA certified QMS are allowed to apply for production permits and product registrations.
ABT’s China facility and laboratory were under renovation last year, and the company took that time to identify the processes needed to establish an approved QMS. After conducting internal analysis and management reviews, ABT submitted its certification request to the Guangdong Province SFDA, which granted the certification after several on-site examinations in late 2012.
“The SFDA certified QMS will enable the company to manufacture and market its products once they are approved by the SFDA,” said Wang Hui, CEO of ABT. “Furthermore, quality management systems around the world are generally based on ISO 13485; this certification will help the company to be accredited in other countries in due course.”
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
ABT’s products are designed to stimulate new bone growth leaving newer, stronger bone in the exact location of an injury; thereby making the site of the injury stronger and more resistant to recurring damage. The company’s aim is to make these products an alternative to metal implants and overcome the limitations of other re-absorbable fixation devices.