MANAMA: Bahrain’s top health authority has signed a deal to fast-track registration services for medical devices.
The agreement between the National Health Regulatory Authority (NHRA) and Medspero Pharma is part of the authority’s efforts to develop and facilitate procedures for registering medical devices and supplies.
NHRA safety adviser Nada Al Sayegh said the authority will continue providing regular services according to the available schedule while allowing cases accredited by the company to be fast-tracked.
“When choosing the accelerated track option the applicant must ensure all requirements are met before the final review by NHRA,” she said.
“Registration will be done within a maximum of one month.”
The NHRA registered 2,513 medical devices last year with the aim of assessing compliance with the safety and performance requirements stipulated in the applicable regulations and standards.
Ms Al Sayegh said 9,174 new devices were evalauated by medical device engineers and the total value of imported medical devices reached more than BD30 million with 23 per cent of import applications rejected.
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