Medical Devices Regulations in Oman – October 2020

We at PRA consultancy just wrapped up our first episode of the podcast REG Voice. This podcast is the very first in the region to address issues and queries related to the regulatory affairs in the medical and health care facility. The main objective of this Podcast was to resolve challenges, highlight the regulations and discuss updates that arise in the healthcare and medical device industry through informative discussions with renowned experts and show you the way forward. In our very first podcast, we had the pleasure of having an insightful and extremely imperative conversation with Eng. Faiza who is the director of medical devices control at the Ministry of Health Oman. We discussed the critical topic which pertained to a new updated official gazette issued by the Ministry of Justice and Legal Affairs of the Sultanate of Oman. #1353. The updated gazette includes guidelines related to the law regulating the practice of the profession of pharmacy and pharmaceutical establishments and medical device registrations.

The new gazette number 1353 was released in August 2020 and through this podcast we discussed significant points related to the implementation of this gazette with Eng.Faiza. The gazette includes one complete chapter on registration of medical device establishment and products and is being introduced in Oman for the very first time.

In our discussion we highlighted the need for a regulated market for medical devices especially in times of a global pandemic. We realise that medical devices are the need of the hour and extremely important for the health of a nation. Additionally, we also realise that the journey to move from a non-regulated market to a regulated market is not going to be an easy one. Successful and easy registration of medical devices is a milestone that we want to achieve and to streamline this journey, the following points were discussed

  • There are currently one hundred and fifty thousand medical devices in the market and registering all of them would require a streamlined process.
    Devices will be classified on the basis of their category and health risks involved.
  • The Ministry will ensure compliance with the WHO guidelines and will follow other health guidelines as well.
  • To ease the registration process of the medical devices , there will be a consideration of other countries or health authority registrations , where the medical device will be automatically approved if it will be registered with the named authority.
  • The impact of the European Medical Device Regulatory Bodies would be taken into consideration as many medical devices are imported from Europe.
  • A standard 5-year certificate will be issued to everyone who applies for registration and in case a registration is pre-approved for a shorter duration the company needs to renew it at the end of its term. The registration for manufacturers and products will happen parallelly.
  • The Ministry of Health would review the listing of medical devices as they want to embrace the change gradually giving everyone enough time to adapt to the new norms.
  • As vigilant and dedicated health care regulatory professionals we want to harmonise the requirements in the GCC region with other authorities and we will take baby steps to get to our goal.
  • Track and Trace will be enforced at a later stage and there will be different requirements for registration of normal medical devices and medical devices with medical substances.
  • Medical devices with substances are regulated by the Drug control department.
  • The registration process will be online to standardise the registration process and make it hassle-free. The Ministry plans to make it live early next year and intends to gauge the market thoroughly before intervening.

This change may seem difficult and new right now however we will gradually and steadily take relevant measures to ensure it’s an easy process for everyone. Workshops will also be conducted to make everyone aware about the new gazette. This podcast was a much needed one and we are always committed to bring information about the latest reforms from the regulatory affair market. We believe that the Regulatory affair department is the heart of the organisation and if it functions well, then the other departments succeed and prosper too.

#medical devices

#oman

Published by:

Mona Al Moussli

Co-founder PRA | Experienced pharma reg affairs consultant | MSc KREMS, Vienna | Middle-East MOH network

Published on: November 18, 2020

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