[Middle East] Key Regulatory Updates on Malaffi, Recall & Compliance

August 3
3 mins

Episode Description

This episode delves into significant regulatory developments impacting healthcare providers and facilities across the UAE, focusing on Quality Defect notifications, integration with the Malaffi Health Information Exchange Platform, and updated recall protocols.

Key highlights include the UAE Ministry of Health and Prevention’s mandate for school clinics to complete technical integration with Malaffi by August 31, 2026, ensuring electronic transmission of compliant health data. Additionally, all healthcare facilities must submit referral data adhering to HL7 and SNOMED standards to support Abu Dhabi’s Primary Care Model.

The podcast also covers the voluntary recall of Panto-Denk 40 mg gastro-resistant tablets triggered by a quality defect notification from the World Health Organization. Healthcare professionals are urged to quarantine affected batches, cease their use, and report adverse events while coordinating recall and destruction with the Emirates Drug Establishment.

For more information, visit the Carver Agents website.

Articles mentioned:

  1. Mandatory Electronic Medical Records in School Clinics
  2. Mandatory Submission of Referral Data to Malaffi in Support of Abu Dhabi Primary Care Model
  1. ورشة توعوية عن قرار المجلس التنفيذي رقم 49 لسنة 2024 بشأن تنظيم مزاولة الانشطة والمهن الصحية في إمارة دبي
  1. Mandatory Spare Parts Inventory Requirements for Critical Medical Devices
  2. Compliance & Guidance
  1. الامتثال والإرشادات
  1. Mandatory Requirements for Peptide Products
  2. How to Submit a Report
  3. The STR Process
  4. Recall of Affected Batches of Panto-Denk 40 mg Gastro-resistant Tablets
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