Topic: MEdical device regulation

Order Description Please refer attached file. We are medical device company. (www.sigmagraft.com) We got FDA approval(product name InterOss. Bone grafting material. please refer website). With FDA approval we are going to sell our products to foreign country. Please make a table following countries: Singapore, Taiwan, Thailand, Canada, Japan, Brazil,Laos, vietnam, Colombia, Argentina, Peru, Malaysia,Mexico Each country has different medical device regulation. Some country need CE or FDA or only CFG. Some country need their own language product label. Please refer attachment and make a table. Country Distributor FDA / CE REVIEW TIME FEE LABEL LANGUAGE CFG LOCAL TESTING Device Class Singapore Local distributor FDA needed Yes Fee for license a generic name Needed Not needed Class II Taiwan Local distributor FDA needed Yes Fee for license No generic name needed Needed Not needed Class II Thailand Local distributor FDA needed Yes Registration fee Local labeling needed Needed Not needed Class II Canada Need no local distributor FDA needed Yes Registration fee needed No local labeling needed Needed Needed Class II Malaysia Local distributor FDA needed Yes Registration fee needed Local labeling needed Needed Not needed Class II Vietnam Local distributor Not needed Yes Registration fee needed Need Vietnamese language Needed Needed Class III Colombia Need no local distributor FDA needed Yes Registration fee needed No local labeling Needed Not needed Class II Japan Local distributor FDA needed Yes Registration fee No local labeling Needed Not needed Class II Brazil Need no local distributor FDA needed Yes Registration fee needed No local labeling Needed Not needed Class II Laos Local distributor Not needed Yes Registration fee needed Need local labeling Needed Not needed Class III Argentina Local distributor FDA needed Yes Registration fee needed No local labeling Needed Needed Class II Peru Need no local distributor FDA needed Yes Registration fee needed No local labeling Needed Not needed Class II Mexico Need no local distributor FDA needed Yes Registration fee needed Local labeling needed Needed Needed Class II The United States Food & Drug Administration (FDA) tests, examines, as well as approving a broad range of substance for medical purpose, including medical appliances and drugs. The term “FDA approval” implies that FDA has evaluated the benefits of approved substance and found that they outweigh the potential risks of that substance. CFG means the Certificate to Foreign Government required by the medical regulatory board. CE Marking on manufactured product is a declaration that product complies with the necessary requirements of pertinent European health, safety & environmental protection legislation (Hickmann, 2003). Reference Hickmann, M. A. (2003). The Food and Drug Administration (FDA). New York: Nova Science Publishers.