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Drug and Medical Device Regulatory Authority

Accredited by: MNAS

The Drug and Medical Device Regulatory Authority, known in Mongolian as Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар, is a certification body in Mongolia. It is responsible for regulating and certifying pharmaceuticals and medical devices to ensure their safety and efficacy. The authority specializes in compliance with international standards such as ISO/IEC 17025:2018, focusing on laboratory testing and quality management.

Ulaanbaatar city, Khan-Uul district, Chinggis Avenue, 20th khoroo, Khabuuli building

Certification Scopes (1)

ISO/IEC 17025

Testing Laboratory

Mongolian National Authority for Accreditation

Mongolia

The Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар certifies laboratories under ISO/IEC 17025 for their competence in testing and calibration. This certification is specifically focused on the analysis of pharmaceutical products and raw materials, ensuring accurate and reliable testing results. The scope includes various chemical and physical analyses essential for maintaining the quality and safety of medical devices and pharmaceuticals.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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