Weekly Regulatory News

SAUDI ARABIA

SFDA Introduces Major Changes to GHTF MDMA License Renewal and Update Requirements

The Saudi Food and Drug Authority (SFDA) has recently introduced new regulatory requirements impacting the renewal and update process for GHTF MDMA licenses. Under these changes, a complete technical file is now required for all renewal and update applications. Approved licenses will be reissued with a new serial number format beginning with MDMA-2, replacing the previous MDMA-1 structure.

Key updates include:

• Renewals can be submitted up to 6 months prior to license expiry

• Jurisdiction (country reference) approval is no longer mandatory

• Government fees remain unchanged until further notice

• Expected processing timelines will increase by 2–3 months

These changes were introduced without prior notification and have already been implemented in the Ghad system. No official written announcement has been issued, and the SFDA has refused to confirm the changes via email. All details have been confirmed through phone discussions only.

We strongly recommend affected stakeholders prepare in advance to avoid delays or disruptions in compliance.

Learn more about SFDA Saudi Arabia Medical Device Registration.

EUROPEAN UNION

Commission Implementing Decision (EU) 2025/681: Updated Harmonised Standards for Medical Gloves, Device Sterilization, and Ambulance Equipment

Adopted on 8 April 2025, Commission Implementing Decision (EU) 2025/681 amends Implementing Decision (EU) 2021/1182 to incorporate new and revised harmonised standards under Regulation (EU) 2017/745 on medical devices. Developed by CEN and Cenelec, these standards reflect the latest scientific and technical advancements, aimed at enhancing safety, performance, and regulatory consistency across the EU medical device sector.

The updated harmonised standards include:

• Medical gloves for single use:

• EN 455-1:2020+A2:2024

• EN 455-2:2024

• Sterilization of medical devices:

• EN 556-1:2024

• EN 556-2:2024

• Patient handling equipment used in ambulances:

• EN 1865-2:2024

• New standard introduced: EN 1865-6:2024

The publication of these standards in the Official Journal of the European Union allows manufacturers to presume conformity with the essential requirements of Regulation (EU) 2017/745. The Decision enters into force on the day of its publication, streamlining compliance processes and supporting the continuous improvement of medical device safety and quality within the EU.

Learn more about EU Medical Device Registration.

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