Gulf Committee for Medical Devices Registration Meets
Gulf Committee for Medical Devices Registration Meets24/12/2018
The 10th meeting sessions of the Gulf Committee of Medical Devices Registration, derived from the GCC Health Council commenced today (Monday) at the City Season Hotel.
The meeting is hosted by the Sultanate, represented by the Ministry of Health (MOH) and attended by Dr. Said bin Harib Al-Lamki, Director General of Primary Healthcare and Member of the Executive Body of the Health Council along with Dr. Mohammed bin Hamdan al-Rubai, Director General of Pharmaceutical Affairs & Drug Control.
The Committee is responsible for registering the medical devices that the producing companies wish to sale in the GCC countries, registering the manufacturers, developing the Gulf regulations and manuals of these products and studying the safety notices of medical devices and products coming to the Committee.
The Committee, which meets six times annually, comprises two members from each country, including the director of surveillance or director of medical devices registration in the regulatory authorities in the GCC countries, as well as Health Council representatives.
The agenda of the meeting includes several topics such as setting standards for inspection of the medical devices manufacturers, reviewing the GCC members views on proposals of unifying the medical equipment classification standards submitted by the Kingdom of Bahrain and reviewing the proposals of the GCC members on the fees of companies' applications to change the registered products.
The meeting also reviews the inspection results of factories of the producing companies, decided on number of applications for registration of medical devices and equipment producing companies, reviews the list of clinical studies, as well as reviews the recommendations of the previous meeting held in November 2018.