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:
| Country | Authority | QM-Regulations |
|---|---|---|
| Australia | Therapeutic Goods Administration TGA | Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3) |
| Brazil | Agência Nacional de Vigilância Sanitária (ANVISA) | Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013) |
| Canada | Health Canada | Medical Device Regulations – Part 1-SOR 98/282 |
| Japan | Ministry 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) |
| USA | Food and Drug Administration FDA | 21 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.
