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WHO Expands Prequalification Programme for Medical Devices

by Torkuma Gbor
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The World Health Organisation (WHO) has expanded its prequalification programme to include more life-saving medical devices, including contraceptives and tuberculosis screening technologies, to improve access globally.

‎The organisation said on Friday in a statement that the expansion aimed to increase access to safe, effective and quality-assured medical devices, particularly in countries with limited regulatory capacity.

‎WHO said its independent, standardised assessment helped governments, donors, procurement organisations and UN agencies identify medical devices meeting international quality, safety and performance standards across various healthcare settings.
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‎“The programme will now cover male and female condoms, intrauterine devices (IUDs), male circumcision devices and computer-aided tuberculosis detection software,” it said.
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‎WHO said prequalification of condoms and IUDs was transferred from UNFPA, strengthening quality assurance for products supporting sexual and reproductive health, family planning and disease prevention.
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‎“Condoms also help prevent HIV and other sexually transmitted infections, while IUDs support prevention of unintended pregnancies and informed family planning decisions.
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‎“WHO has incorporated male circumcision devices into its broader medical device prequalification framework, supporting standardised and safe voluntary medical male circumcision services,” it said.
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‎According to WHO, voluntary medical male circumcision can reduce men’s risk of acquiring HIV through heterosexual exposure by approximately 60 per cent, supporting broader HIV prevention efforts.
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‎“The programme will also assess computer-aided detection software that uses digital chest X-rays and artificial intelligence to identify people requiring further tuberculosis testing,” it said.
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‎It quoted WHO as saying the technology could support earlier tuberculosis detection and faster referral for diagnosis and treatment, particularly in countries with high tuberculosis rates.
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‎According to WHO, Sylvie Briand, WHO Chief Scientist and Assistant Director-General a.i. for Health Systems, Access and Data, said quality standards would strengthen confidence in essential medical devices.
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‎“The expansion is particularly important as many countries face weak regulatory systems, with WHO estimating that about 70 per cent report inadequate regulation of medicines and vaccines,” it said.
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‎(NAN)
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