Does your product change the world? It’s often the case that a new invention doesn’t fit the technical standards which apply to old technology. This was the case for a US manufacturer of innovative X-Ray imaging equipment which had been denied approval for their innovative portable X-Ray device because its cutting edge features were actually prohibited by the current Chinese National Standard.
Brandwood Biomedical worked with the Chinese Test centre to define an overseas clinical data package which would provide the necessary assurances of safety and performance to allow the Test Centre to exempt the device from the “old Tech” clauses of the standard. The Test Centre report was accepted by CFDA and approval followed a short time later.
Got a ground breaking product which challenges the status quo? It may be necessary to negotiate an exemption to part or all of a technical standard. Our team includes technical experts on software, biocompatibilty, electrical safety, biological origin materials and more. We are active particpants in the standards writing process, with decades of experience of participation in ISO and national standards writing. We understand how standards work and are skilled in their interpretation and application.
Let us help you ensure that your innovation isn’t stalled by old ways of thinking. Contact Us for a free, no obligation appraisal.