Approvals (other than EU)
As one of the few Notified Bodies in Europe, the mdc has a recognition in Taiwan under the Technical Cooperation Program (TCP II). Proof of a certified QM system according to ISO 13485 with a special audit report written by mdc can facilitate our product approval in Taiwan for our customers based in Europe so that an audit by one of the Taiwanese auditors is not required.
Canada, USA, Brazil, Japan and Australia:
We offer our customers a specific certification as part of a collaboration with an auditing organization recognized under the Medical Device Single Audit Program (MDSAP). The requirements are based on ISO 13485 and are supplemented by country-specific requirements (for Canada, USA, Brazil, Australia and Japan). The certificate under MDSAP is mandatory for products from class 2 in Canada and in other countries the approval process can be significantly shortened or further audits can be reduced by the respective national authorities.
In Ukraine there is a system similar to the Notified Bodies in the EU. We have a cooperation with the Ukrainian agency Improve Medical LLC. Manufacturers who apply for product approval in Ukraine through this site can benefit from this cooperation, which recognizes mdc certification to EU guidelines from Improve Medical.