MORE than 60 per cent of companies dealing with medical equipment in Bahrain risk losing their licence to operate as they are yet to register under the kingdom’s health regulators.
The National Health Regulatory Authority (NHRA) has announced that it would ‘write off’ the activities of these companies if they fail to register with the authority before the end of the year.
The move is part of Bahrain’s ambitious strategy to wipe out counterfeit equipment in its healthcare sector.
The GDN reported last year on the NHRA’s six-year strategy (2020-2026) which is based on two key regulations that govern the import and sale of devices in Bahrain – one which was set earlier focusing on services related to medical devices and in 2020 dealing with its quality control.
NHRA chief executive Dr Mariam Al Jalahma said that only 144 of the 400 companies in Bahrain that are engaged in importing medical devices and supplies have the official registration to do so.
“The total number of companies registered in Bahrain (importing medical devices and supplies) is about 400, while only 144 companies have been registered,” she confirmed to the GDN.
“They should complete the registration within the specified period, as the authority aims to ensure that all requirements for medical devices are applied in these companies.
“This includes storage, transportation of medical devices, keeping distribution records and other requirements and this aims at ensuring the quality and safety of medical devices and supplies used in the health sector.
“This in turn, contributes to raising the quality and efficiency of health services in the country.”
In a statement signed by Dr Al Jalahma, the NHRA stipulated December 31, 2022 as the last date for the companies to register.
The announcement is in line with the authority’s 2020 resolution related to regulating the control of medical devices in Bahrain.
“We call upon all companies importing medical devices and supplies to initiate registration before the end of the year, as the NHRA will write off the activity of such companies if they fail to register with the authority within the specified time period,” said a statement.
The NHRA is also hosting a training workshop on August 17 and 18 to help companies in their registration process.
“The sessions will train the companies on the registration mechanism and will also respond to all related inquiries.
“The companies will also be taken through all the steps and requirements of the registration process.
“Companies wishing to participate in the workshop are welcome to attend the sessions.”
As per NHRA’s strategy, by 2025, all healthcare facilities in Bahrain must obtain permits to use medical devices that are registered under the authority, adhering to its phase-wise guidelines.
By February 2026, all medical devices must be registered at the NHRA for use or sale.
Senior medical officials said that the new strategy would play a key role in patient safety. They explained the need to spot medical devices with corrective safety action or recall, failure of which is tantamount to putting patient safety at risk.
The GDN reported earlier this year that Bahrain imported medical devices worth more than BD35 million and reviewed 9,644 requests to import medical equipment last year.
raji@gdnmedia.bh
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