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Medical Devices – Asia Regulatory Updates round up – Aug 2021


An online system for processing of applications of establishment license to import or manufacture medical devices. The web portal and user guide is available on home page of DRAP website under the heading “DRAP MIS System”, titled MDMC Online System for Establishment of License (

Circular No. I (24) 2021. Based on circular dated 19/3/2018 regarding the National Registry of Medical Devices and the Resolution No. (48) of 2020 On Medical Devices and Products’ Quality Control, article(8), Which states II that “All health care facilities must take Authority permit to use medical devices and products before using them . “ we are leased to inform you that NHRA is initiating the second phase of the national program of permit to use which includes providing the quality assurance certificates for the previously listed devices on Phase one of the program which reached the total of 21,631 edictal devices by sending the required documents to the edictal devices regulation team email: [email protected]

Warning to consumers about home self-test kits