MOHAP is the primary regulatory body in the UAE, responsible for setting standards and regulations for medical devices, pharmaceuticals, and cosmetics. Its mission is to enhance the quality of products and ensure consumer safety.
- Product Registration with the Ministry of Health (MOH):
Facilitating the registration process for medical devices with the MOH, ensuring adherence to local regulatory requirements.
- Listing of Products with the Health Authority – Abu Dhabi (HAAD):
Managing the listing process for medical devices with HAAD, including the preparation and submission of all required documentation.
- Listing of Products with Dubai Health Authority (DHA):
Assisting with the registration and listing of medical devices with DHA, ensuring compliance with their specific regulatory guidelines.
- Registration and Compliance with Emirates Authority for Standardization and Metrology (ESMA):
Registering medical devices with ESMA and fulfilling all post-marketing requirements, including compliance with Emirates standards and regulations.
- Regulatory Compliance Audits:
Conducting audits to ensure that medical devices meet ongoing compliance requirements and preparing clients for regulatory inspections.
- Regulatory Intelligence and Updates:
Providing insights into emerging regulatory trends and changes affecting medical devices in the UAE and advising on how to adapt.
- Labeling and Packaging Compliance:
Ensuring that the labeling and packaging of medical devices meet local regulatory requirements and standards.
- Post-Market Surveillance:
Monitoring and managing the performance of medical devices in the market to ensure continued compliance and address any issues that arise.
- General Regulatory Consultations:
Offering expert advice on a broad range of regulatory and compliance issues relevant to the medical device industry in the UAE.