sfm is certified according to MDSAP!

We are pleased to announce today that we, sfm medical devices GmbH as well as our subsidiary safemed medical devices s.r.o., are now certified according to MDSAP (Medical Device Single Audit Program) in addition to ISO 13485:2016 since August 2022. After a comprehensive audit, the certificate was issued to us by TÜV SÜD America, Inc. This new certificate confirms to us the continued development and maturity of our organization.






Many medical device manufacturers are aware of the burden and expense of performing various audits and inspections due to regulatory requirements in different countries. This has given rise to the desire to centralize this dispersed effort through a single, yet comprehensive, audit. 

The following countries and authorities are combined under MDSAP:

Australia  Therapeutic Goods Administration TGAAustralian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
BrazilAgência Nacional de Vigilância Sanitária (ANVISA)Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)
CanadaHealth CanadaMedical Device Regulations – Part 1-SOR 98/282
JapanMinistry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)
USAFood and Drug Administration FDA21 CFR Part 803
21 CFR Part 806
21 CFR Part 807 – Subpart A to D
21 CFR Part 820


In the meantime, an audit according to MDSAP is mandatory for access to the Canadian market. 

We are proud of our performance during the certification audit and are looking forward to serve new markets.