Recently, Xiamen Boson Biotech passed the Medical Device Single Audit Program (MDSAP) certification and received the MDSAP certificate. The MDSAP quality system certificate will not only help Boson further expand the international market, but also promote the company’s medical device quality management system to a new level and provide more quality products and services to our customers.
The MDSAP certification program is a new audit process recognised and joined by the regulatory bodies of five countries – USA (FDA), Australia (TGA), Brazil (ANVISA), Canada (HC) and Japan (MHLW). It is worth mentioning that the certification is a substitute for partial audits and routine inspections and market access in the above-mentioned countries, and therefore the certification requirements are high.
