CMS was accredited as a Third Party Reviewer of US FDA 510(k) for eligible medical devices and approved to conduct quality system inspections of medical device manufacturers under the FDA Medical Device User Fee and Modernization Act.CMS staffs have served as the chair of the Asian Harmonization Working Party Technical Committee, the member of the Global Harmonization Task Force, and expert observer of ISO.

Domestically, CMS is a medical device GMP inspection body designated by the Department of Health (DOH) and the third party reviewer of Class II IVD. We perform research projects commissioned by DOH in the areas of medical device regulation such as medical device GMP, reclassification of medical devices, guidelines for human cell/tissue based products and IVD devices. CMS is dedicated to coordinating the operations of the Asian Harmonization Working Party to promote communication on medical device regulatory systems between the R.O.C. and other Asian economies to promote international harmonization.

A Medical Device Testing & Evaluation Center is under construction. Besides the regulatory review and inspection, this center is expected to enhance the quality of domestic medical device by evaluation and certification.

For more details, please refer to its website at http://medical.cms.itri.org.tw.