BD45m medical devices imported

BAHRAIN imported medical devices worth more than BD45 million last year, it has emerged.

The National Health Regulatory Authority (NHRA) said it had registered 1,144 medical equipment last year.

The information was revealed in the authority’s annual report for 2020, which also highlighted violations and complaints related to medical devices, recalls, investments as well as NHRA’s achievements in the field.

“The total number of applications for new medical devices, evaluated by engineers, reached 11,415 – of which 11,137 were processed through the Electronic System of Customs,” said the report.

“The total value of the imported devices was BD45,221,710.090.

“The authority rejected 21.6 per cent (2,465) of applications submitted for import due to detection of a false certificate or a counterfeit device.”

The report also noted that the authority added new guidelines for medical devices for Covid-19 and import and manufacture of hand sanitising gel.

The NHRA identified 74 device violations last year – 54 had fake certificates, 16 were counterfeit devices and four were bogus instruments.

The numbers reflected a dip from the previous year (2019) which reported 312 violations of which 253 were certified fake, 35 were counterfeit devices and 24 were bogus instruments.

The authority also recalled 58 medical devices and issued a field safety notice to 39 others, which was an increase from the previous year which recorded 28 and 20 respectively.

Of the 11,415 requests that the authority received for importation permits, 8,950 (78pc) were approved, while 2,465 (22pc) were rejected.

“A new Covid-19 technical review was conducted for various technologies which included inspections, technical file assessment and post market report studies (for example, locally manufactured ventilators, uv light, disinfectant tunnel, Covid-19 rapid test, N95 mask, portable hepa filter, sanitisers, air purifier, airductor and applications and watches),” the report said.

The NHRA also started registering local manufacturing sites for which it received nine applications – one was given the green light and two were granted the initial approval.

The authority closed one beauty spa and confiscated all devices owing to rampant misuse.

NHRA chief executive Dr Maryam Al Jalahma said the year was “very productive” despite the challenges posed by the pandemic.

“The course of the pandemic has shown us that making predictions is unusually difficult at the moment,” she said.

“In addition to our regular operations and processes, NHRA was instrumental in complementing the directives of the Covid-19 national taskforce by organising awareness campaigns and trainings in co-ordination with private healthcare facilities.

“We temporarily suspended cosmetic procedures, cupping therapy, fertility, and other related non-emergency procedures in dental and dermatology in the private sector.

“The authority also conducted regular inspection visits to ensure adherence to protocols and infection control measures, granted approvals to private facilities to provide quarantine and isolation services, and supervised the Hidd quarantine centre, among others.”

However, according to her, the highlight of the year was the efficient review and emergency authorisation of the use of two international vaccines against Covid-19 “that has provided the people of Bahrain some relief from the events of the year”.

Bahrain approved Pfizer BioNTech and Sinopharm vaccines for emergency use in December while the other three – AstraZeneca-Covishield, Sputnik and Johnson & Johnson), which it approved subsequently, were under review.




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