DGPADC Organizes Workshop on Medical Devices Regulatory

DGPADC Organizes Workshop on Medical Devices Regulatory

DGPADC Organizes Workshop on Medical Devices Regulatory

7/11/2018

The Ministry of Health (MOH), represented by the Directorate General of Pharmaceutical Affairs & Drug Control (DGPADC) organized on (Wednesday) a workshop the First Medical Devices Regulatory at the Levatio Hotel Muscat.

The workshop held under the patronage of H.E. Dr. Mohammed bin Saif Al-Hosni, MOH Undersecretary for Health Affairs in the presence of H.E. Dr. Akjemal Magtymova, Representative of the World Health Organization (WHO) to the Sultanate.  

The workshop gathered around 100 participants from the engineers and technicians of medical equipment, nurses, pharmacists and other institutions working in manufacturing, importing and selling the medical devices and equipment. 

Dr. Nazeeh Al Othmany, WHO Consultant for Medical Devices along with a number of lecturers gave lectures about the relevant applicable global regulations. The lecturers touched on unifying efforts against counterfeit medical devices, the medical devices regulation in Oman, the Global Medical Device Nomenclature System (GMDN), effective quality management system in the areas of medical devices manufacturing, safety and efficacy of medical devices…etc.

The workshop aimed at activating the Equipment and Medical Devices Control Department (EMDCD) which was developed recently in the new DGPADC structure. The EMDCD concerned with all steps of accreditation and registration all medical devices and equipment, as well as its trading and monitoring at all steps including manufacturing, marketing, during and post marketing according to the international standards.

Dr. Mohammed Al-Rubaie, DGPADC Director-General pointed out in his welcoming speech that the WHO has called upon all the Member States in its 67th General Assembly Meeting in 2014, to build regulatory regimes for the medical devices and equipment to ensure the safety and efficacy of these products that enter the markets, as well as to prevent and combat of the low-quality and counterfeit products. He also added that the WHO urged the Member States to develop systems for the good manufacturing, market censorship and to receive equipment accidents reports.

Dr. Al-Rubaie indicated to the importance of the medical devices as they are a vital part in diagnosis, treatment and prevention of diseases. Therefore, the Ministry of Health has developed the Equipment and Medical Devices Control Department (EMDCD) in the Directorate General of Pharmaceutical Affairs & Drug Control. He added that the market size of the medical devices and equipment in the Sultanate is estimated at around 100 million Omani Riyal, while around 100,000 medical devices and equipment is being traded in the Sultanate.

The workshop came out with a number of recommendations and suggestions including that the WHO indicates that 8% of medical devices in the World are counterfeit, therefore, the countries need to build a regulatory system for these devices to protect the humanity from the low-quality and counterfeit products. In addition, all different authorities should work together to ensure the safety of medical devices before entering the Sultanate, as well as follow-up while trading and using.

It is worth mentioning that, Dr. Nazeeh Al Othmany, the WHO Consultant has visited the DGPADC and briefed on the systems used in registering the medical devices and equipment and all other regulatory procedures such as allow to trade and monitor these devices and equipment, as well as its regulations and legislation. The visit aimed at developing the necessary proposals and recommendations to strengthen these systems to keep pace with what is being followed at the regional and international levels.  



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