Medical devices worth BD30 million imported

BAHRAIN imported medical devices worth more than BD30 million last year, it has been revealed.

The National Health Regulatory Authority (NHRA) also said it had registered 2,513 medical devices last year.

The information was revealed in the authority’s annual report for 2019, which also highlighted the various types of violations related to medical devices, recalls as well as the NHRA achievements in the field.

“The total number of new medical device applications evaluated by the medical device engineers reached 9,174, of which 8,783 applications were processed through the Electronic System of Customs (Ofoq),” said the report.

“While 391 requests were manually processed in relation to the combined medical devices.”

“The total cost of the imported devices was BD30,382,973.400.

“The authority rejected 24 per cent (2,160) of the total applications submitted for import due to either the detection of a false certificate or a counterfeit device.”

Safety

The report said the registration process aimed to determine if a device was in compliance with safety and performance standards set out in applicable regulations and standards.

The NHRA also identified 312 device violations last year, of which 253 had counterfeit certificates, 35 were counterfeit devices and 24 were fake instruments.

The authority also recalled 28 medical devices and issued a field safety notice to 20 others.

Of the 159 authorised requests that the authority received for registration, 67 were approved, 82 were raised as defects and 10 were rejected.

Initiative

Among the medical device achievements, the report cited the implementation of a five-year plan to be the first national initiative on a permit to use medical devices in healthcare facilities.

It also highlighted that 10 of its staff had been certified as lead auditors for quality management system for medical devices.

“The implementation of processes to efficiently review applications of Ofoq within 24 hours and a five-year plan on a permit to use medical devices in healthcare facilities are also among the achievements.

“An online appointment system for procuring medical devices was established and NHRA also translated nine international ISO standards to Arabic in order to be recognised globally.

“The NHRA also signed a memorandum of understanding with Saudi Food and Drug Authority.”

It issued 14 new guidelines applicable in the field and also issued a decision to create the first National Committee for Medical Device Standards to review global draft standards before being recognised on a GCC level.

Meanwhile, the authority received four applications for clinical trials of which half were from the government sector.

“The NHRA has well-established guidelines for conducting clinical trials in Bahrain and in 2019 the Stem Cells Clinical Trials Guidelines were established and approved by the Supreme Council for Health,” said the report.

“The unit received four applications for clinical trials of which half were from the government sector.

“The trials submitted were in the field of diabetology, haematology, respiratory disease and obstetrics and gynaecology.”

Out of the four, one was approved and procedures have been completed on another, while the remaining two are pending, added the report.

Source: http://www.gdnonline.com/Details/824612/Medical-devices-worth-BD30-million-imported