The international regulatory landscape continues to evolve — and this time, the focus is on the UK regulatory authority.
The MHRA has launched a public consultation that could reshape market access strategies in Great Britain for medical device and IVD manufacturers holding CE marking.
At the same time, updates in Brazil and the United States reinforce a global trend: regulatory predictability, operational simplification, and strengthened oversight remain at the center of regulatory discussions.
In this article, we outline the key developments that may impact the regulatory planning of companies operating internationally.
The UK Regulatory Authority and CE Mark Recognition
The UK regulatory authority (MHRA) has opened a consultation proposing the indefinite recognition of CE-marked medical devices in the Great Britain market.
The proposal comes in direct response to post-Brexit uncertainties and recurring industry requests for greater stability in the UK market access framework.
Currently, a significant portion of devices marketed in Great Britain still rely on CE certification, while the UKCA model has not yet been fully consolidated as the exclusive standard.
The consultation includes three main proposals:
– Possible continued recognition of CE marking
– Extension of transition deadlines for devices certified under the MDD until December 2028
– Creation of an international recognition route for devices classified as higher risk under UK regulations
If approved, these proposals could reduce immediate transition costs and allow for more strategic regulatory planning.
On the other hand, the proposal also signals potential changes in oversight dynamics. Certain devices could be accepted without UK pre-market review, while continuing to be monitored under European regulatory structures.
For companies operating in the UK or planning expansion, closely following the next steps of the UK regulatory authority is essential for investment decisions, market prioritization, and regulatory risk management.
Anvisa Simplifies GMP Certification Process for Medical Devices
In Brazil, Anvisa has announced the unification of subject codes used when petitioning for the Certificate of Good Manufacturing Practices (CBPF) for medical devices.
Although the measure does not change the requirements established under RDC 497/2021, it simplifies operational workflows within the Solicita system.
The separation between medical device and IVD production lines remains mandatory, but the administrative process becomes more streamlined.
In recent weeks, Anvisa has also participated in official missions to India and several African countries. The objective is to strengthen regulatory dialogue and expand cooperation in healthcare, medical devices, pharmaceuticals, and cosmetics.
This type of movement signals a push for greater international integration. In the long term, it may influence regulatory harmonization processes and commercial opportunities.
FDA Reinforces Biennial Renewal Requirements Under MoCRA
In the United States, the FDA has updated the Cosmetics Direct portal and related guidance materials to support the biennial renewal of cosmetic facility registrations, as required under MoCRA.
The updates include automated reminders, registration status visibility, and revised submission instructions.
This initiative reinforces the consolidation of the new regulatory framework for cosmetics in the U.S. market, with increased traceability and formal oversight of facility registrations.
Companies operating in the sector should carefully monitor their deadlines, as renewal must occur every two years from the date of initial registration.
Monitoring as a Strategic Tool
The initiatives of the UK regulatory authority, combined with updates from Anvisa and the FDA, demonstrate that the global regulatory environment continues to evolve.
For companies operating across multiple markets, actively monitoring these changes should be part of corporate strategy — not only as a compliance requirement, but as a competitive advantage.
Understanding what each regulatory authority signals today can translate into cost savings, risk reduction, and greater predictability tomorrow.
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By doing so, you will receive in your inbox the key regulatory developments from around the world — whether from the UK regulatory authority, Brazil, or your target markets.
