Grant Ramaley

The medical device trade is not like any other. It impacts individuals ranging from the unborn to those requiring support in older age. Regulating these devices has never been more important, especially for developing countries that are writing their medical device regulations. More regulators, including the U.S. FDA (Food and Drug Administration), are turning to ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes to support Regulatory Convergence.

As the largest group of medical device regulators in the world, the Asian Harmonization Working Party prepared “Playbook for Implementation of a Medical Device Regulatory Framework”, which has now been posted by the World Health Organization. It features ISO 13485 as the only recommended quality management system that should be used for regulating medical devices, especially those that are higher risk to patients.

IAF has been actively involved in supporting the AHWP, including training of regulators on the virtues of ISO 13485.  Much has been shared with them, regarding internationally accredited certification of the same type supported by IAF and endorsed by the International Organization for Standardization.

More recently, these same regulators have been voicing enthusiasm for the IAF CertSearch Database.  Some have expressed concern regarding the legitimacy of some of the ISO certificates they receive and perceive IAF CertSearch as a valuable tool for screening.  IAF CertSearch prevents fake certificates from being entered into it, as it only includes certificates validated through the IAF chain of accredited certification.

There are an estimated 96 accredited conformity assessment bodies worldwide issuing 20,000 to 30,000 ISO 13485 certificates.  Although comparatively small in sheer numbers of certificates, compared to ISO 9001, the vast majority of trustworthy medical devices come from companies holding these certificates. 

ISO 13485 is not just a passport of trade between the medical device industry, regulators and healthcare institutions; it is also viewed as a critical support to protecting citizens worldwide.  IAF CertSearch is making this work even better, especially for highly tasked regulatory authorities that do not have the resources to check every certificate they receive.  IAF CertSearch is adding more to healthcare protection than ever before.