NSAI Offers Device Certifications Within 60 to 90 Days

A U.S. subsidiary of the notifying body National Standards Authority of Ireland (NSAI) is refocusing its certification efforts by offering device manufacturers a program where they can obtain a CE mark or Canadian Medical Devices Conformity Assessment System (CMDCAS) certification within 60 to 90 days, Chris Morrell, vice president of NSAI’s U.S. division, told MQN.

Morrell explained that it often takes device manufacturers 90 to 120 days just to get on a schedule for certification, and it could take months to years for firms to obtain CE marks and CMDCAS certifications.

Although the notifying body cannot currently certify devices intended for distribution in Japan, it expects to be able to grant such certifications by late 2007 or early 2008. During the same time frame, the company expects to be able to participate in the FDA’s third-party inspection program for premarket notifications, or 510(k)s, Morrell said.

Under NSAI’s new programs, device manufacturers will receive package pricing for medical device certifications ranging from $5,000 to $15,000.