Femasys' FemBloc Gains MDSAP Certification for US, Canada, Japan, Australia, Brazil
Femasys’ FemBloc permanent birth control system received MDSAP certification, enabling accelerated regulatory and commercial rollout across the United States, Canada, Japan, Australia and Brazil. The certification reduces regulatory risk, bolsters manufacturing readiness for a pivotal US trial toward PMA submission and enhances global market entry including ongoing European commercialization.
1. MDSAP Certification Achievement
Femasys’ FemBloc system earned Medical Device Single Audit Program certification, marking compliance with quality standards required by regulatory authorities in the United States, Canada, Japan, Australia and Brazil. This certification aligns FemBloc with Femasys’ existing MDSAP-approved portfolio.
2. US Regulatory Advancement
FDA recognition of MDSAP demonstrates high quality system maturity, supporting Femasys’ pivotal clinical trial toward a PMA submission in the US. The reduced regulatory risk and documented manufacturing readiness position FemBloc for expedited review.
3. Global Commercialization Strategy
Internationally, the certification enhances manufacturing credibility and operational scalability, supporting existing European commercialization and facilitating entry into additional high-value regions. Femasys aims to leverage this milestone to pursue strategic partnerships and accelerate revenue growth in underserved markets.