Today, the resounding echo of the starting gun reverberates globally, signaling the commencement of a pivotal two-year transition period for device manufacturers and importers. This period marks the urgent need for them to adapt and enhance their quality management systems in alignment with the requirements of the Quality Management System Regulation (QMSR). The long-awaited final rule, issued by the FDA, has been a focal point of anticipation within the medical industry. The call for harmonization between ISO 13485 and the Quality System Regulations (QSRs) has persisted for decades, gaining heightened significance since its formal announcement in 2018 and the subsequent release of the proposed rule in February 2022.
This definitive ruling amends the current good manufacturing practice (cGMP) requirements of 21 CFR 820, not only to perpetuate the safety and efficacy of medical devices entering the market but also to foster uniformity in device regulation. This marks a monumental stride towards global harmonization, addressing the multifaceted requirements of diverse regulatory frameworks in a logical and coherent manner. Furthermore, the standard’s pivotal role as the foundation of the Medical Device Single Audit Program (MDSAP) underscores its efficacy as a proven model for harmonization.
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Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP) | FDA
