Wuhan EasyDiagnosis has completed the MDSAP quality system certification and obtained the MDSAP certificate issued by the international authoritative AO organization TUV Rheinland North America.
The MDSAP Medical Device Single Audit Program (MDSAP) project is co-sponsored by the MADSAP Regulatory Agency Committee of IMDRF (International Medical Device Regulators Forum), A new set of review procedures have been recognized and joined by regulatory agencies, which are including the United States (FDA), Australia (TGA) and Brazil (ANVISA). WHO is currently an observer.
The single audit procedure of MDSAP is carried out by an audit agency authorized by MDSAP, which establishes a set of single audit procedures to meet and unify the audit requirements of the five countries, making the audit more comprehensive and effective. Multiple audits or factory inspections currently exist, so medical device manufacturers can reduce the number of overall audits or factory inspections, optimize the time and resources spent on audits, and reduce production disruptions due to audits.
The introduction of MDSAP has made the auditing process international standard, reducing the burden on medical device manufacturers.
Joining the MDSAP can serve as proof of a medical device manufacturer's commitment to producing high-quality and regulatory-compliant products. MDSAP certification cannot completely replace the audits of the competent authorities of participating countries, but the recognition of the results of the MDSAP certification audits does not mean that the competent authorities give up their supervisory powers, and audits will still be conducted when the competent authorities deem it necessary.
The MDSAP quality system certificate obtained by Wuhan EasyDiagnosis covers four of the five countries: the United States, Brazil, Australia and Canada. The certification scope includes novel crownvirus nucleic acid PCR test kits, COVID-19 antigen test kits, blood gas reagents and the development, production and sales of the related products of blood gas analyzer.
The company officially started the certification of the MDSAP quality system certificate in January 2022, and obtained the MDSAP quality system certificate issued by the AO organization TUV Rheinland North America in April 2022.
Obtaining the MDSAP quality system certificate will not only further accelerate the pace of EasyDiagnosis's globalization development strategy, but also promote the company's medical device quality management system to a new level, so that EasyDiagnosis products have better quality assurance.
In the future, Wuhan EasyDiagnosis will provide more high-quality products and services to more countries and regions around the world, and contribute to human health.