The FDA has published a new Draft Guidance detailing the transition to the Quality Management System Regulation (QMSR). It is considered one of the most significant revisions to the Agency’s quality regulatory framework in recent decades.
The goal is to further align FDA requirements with the principles of ISO 13485:2016, consolidating harmonization between the two.
The document proposes terminology adjustments and revised responsibilities. It also clarifies what will be required in audits, inspections, and technical submissions.
This FDA ISO 13485 harmonization effort requires manufacturers to review their quality management systems. This review is essential for compliance! It particularly impacts processes such as design control, CAPA, and traceability.
Future submissions to the FDA may demand more robust evidence of conformity, impacting timelines and the scope of audits.
This transition marks an important step in FDA ISO 13485 harmonization and should guide regulatory strategies in the coming years.
For companies operating in the U.S. market, this movement represents both a warning and a strategic opportunity. Those who prepare early reduce risks and strengthen their competitive position.
Tip: if you want to prepare your team for ISO 13485, you should learn more about Sobel’s exclusive training (online or in person). Send us a message to receive more information about our ISO 13485 training!
Anvisa announces plan to reduce the medical device backlog
Anvisa has announced a webinar to present its new plan to reduce review queues related to medical devices.
The initiative aims to make timelines more predictable and increase the efficiency of technical assessments. This is a critical point for manufacturers awaiting registrations, renewals, or post-approval changes.
The webinar takes place on November 24 at 3 p.m. (BRT) and should detail all upcoming measures. Register here.
TGA to accept UKCA certifications
The Therapeutic Goods Administration (TGA), Australia’s regulatory authority, has published an update confirming that it will begin accepting UKCA certifications as part of the medical device evaluation process.
This change expands regulatory equivalence pathways. It allows manufacturers certified in the United Kingdom to use this technical basis to streamline access to the Australian market.
With this new acceptance, companies operating in multiple markets can structure their portfolios more efficiently, leveraging existing evidence.
For manufacturers that already have UKCA or plan to obtain it, this update is an opportunity to accelerate time-to-market in Australia and optimize their international registration strategy.
Working Group publishes draft of future ISO/TS 23485
The ISO technical committee has published the first draft of ISO/TS 23485, a guideline created to support the practical implementation of ISO 13485.
The document is expected to provide interpretative guidance, examples of best practices, and directions for auditors, reducing inconsistencies in how the standard is applied.
For companies that rely on ISO 13485 as the foundation of their quality system, this development is especially relevant for audits and ongoing compliance.
Why these updates matter
Taken together, these announcements point to a global trend toward greater regulatory alignment and stronger quality management systems.
FDA ISO 13485 harmonization is not just a technical adjustment — it signals that authorities are seeking to standardize expectations and reduce discrepancies between markets, making the regulatory environment more predictable.
At the same time, initiatives such as Anvisa’s backlog reduction plan, TGA’s recognition of UKCA, and the development of ISO/TS 23485 reinforce the need for continuous updates on the part of companies.
Anyone operating in regulated markets must follow these changes closely to ensure compliance and maintain a competitive edge.
And if you want to receive these updates quickly, subscribe for free to the Sobel News Round Up and get regulatory news that impacts your business directly in your inbox.
