Overview

To oversee manufacturing, importing, and marketing activities of healthcare products in the United Arab Emirates (UAE), the UAE government has introduced a stringent product certification scheme called Emirates Conformity Assessment Scheme (ECAS) mandated by the Federal law 28 of 2001. ECAS certification is issued by Emirates Authority for Standardization and Metrology (ESMA) to the UAE importer or distributor after validating or observing the products’ compliance with UAE national regulations. The core focus of ECAS is to oversee all regulated products meet the requirements for safety and quality specified in the technical regulations adopted by the UAE government. Given the scenarios like factory inspection, audit, and data submissions to obtain the mark of conformity, proceeding with a successful ECAS seems a challenging situation for manufacturers or suppliers to navigate the procedures.  

Having a strong local presence in Duabi, UAE, Freyr understands clients’ Regulatory requirements right on time and leverages its expertise to deliver end-to-end quality services for the ECAS certification program. Right from seeking product approval in the quickest turn-around-time to obtaining the mark of conformity to post-market surveillance services, Freyr, with its well-established local health authority knowledgebase on ESMA, assists organizations throughout the lifecycle.  

Freyr Capabilities

  • End-to-end Regulatory support for ECAS certification
  • Review information, data, and materials required for ECAS certification
  • Review valid test reports, UAE trade license, and declaration of conformity
  • Review Product identity declaration and plug declaration
  • Technical review to ensure application is complete conforming to all requirements
  • ECAS “Life Cycle Management”
  • Mark of Conformity

Freyr Advantages

  • Dedicated regional delivery centre
  • Proven Regulatory affairs expertise
  • Strong ESMA knowledgebase
  • Economical, flexible and quick ECAS certification turn-around-time