Femasys obtains MDEL from Health Canada

Femasys announced that it has obtained a Medical Device Establishment License, MDEL, from Health Canada. The MDEL license is issued by Health Canada’s Regulatory Operations and Enforcement Branch, ROEB, to companies for the activities of manufacturing, importing and distributing and selling of medical devices for human use in Canada. This license allows Femasys to directly sell its four products, FemaSeed, FemVue, FemCath and FemCerv, approved in Canada. “Obtaining an MDEL license is another milestone achieved and key step to entering the Canadian marketplace,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “We are thrilled to provide women in Canada access to Femasys’ medical products for infertility treatment and diagnosis, as well as cervical cancer diagnosis.”