Radar | Apr 17,2020
Aug 11 , 2024
By BEZAWIT HULUAGER ( FORTUNE STAFF WRITER )
The Ethiopian Food & Drug Authority (EFDA) has relaxed requirements for manufacturing products classified as "low risk," a category that includes sanitary pads, diapers, prosthetics, and over 700 other medical devices and equipment, having minimal user contact and no interaction with internal organs.
Signed by Director-General Heran Gerba, the directive aims to streamline regulatory processes while maintaining safety, quality, and effectiveness standards. The directive also emphasises transparency and accountability in the layout, design, location, construction, and maintenance of manufacturing premises. It further outlines requirements for device and utility installations, warning that non-compliance could result in credential suspension.
The Authority classifies medical devices into four risk categories, ranging from high to low. Mikiyas Petros, head of medical device manufacturers' inspection & enforcement at the Authority, the directives for other categories will be introduced next.
For low-risk manufacturers, previous stringent requirements, such as having a minimum of five separate rooms for production, have been reduced to two. The mandate for a technical manager with a pharmacy degree and three years of experience, along with the need for multiple professionals in the production process, has been simplified to require only one qualified professional, with no experience necessary.
Officials hope these changes will cut down bureaucratic red tape, making it easier for local manufacturers to obtain the necessary certification and ultimately save foreign exchange reserves. Mikiyas noted that better-informed manufacturers will now face lower compliance costs, recalling instances where companies rented premises that later failed to meet the standards.
According to the directive, all product information and labels must be provided in both English and Amharic, with scientific evidence backing all claims. Primary packaging must contain a single unit of use, while secondary packaging should protect individual units. If labelling is applied directly to the medical device, it must be durable and resistant to removal during cleaning, disinfection, or sterilisation.
Manufacturers have responded positively to the reduced regulatory burden. Yididya Seleshi, general manager of Gilando Biomedical Solutions Plc, anticipates that these changes will spur local production, noting that previous requirements were difficult, particularly in terms of human resources.
"This is something we've been asking for," Yididya said.
He recalled instances where overqualified staff were required to produce low-risk devices, despite the lack of need for advanced expertise or complex technology. His manufacturing site at Jemo 3 area, produces medical equipment such as stretchers.
"It'll be easier now," he told Fortune.
Imported low-risk devices will continue to undergo a separate safety verification process, with the Authority ensuring that manufacturers are certified by the World Health Organisation (WHO). According to the WHO, approximately two billion people worldwide lack access to essential medical devices and pharmaceuticals, driving demand for lower-cost products and increasing the risk of falsified and counterfeit goods entering the market.
Getasew Amare, a health economist and lecturer at Gonder University, praised the Authority's decision. He sees the reduction of entry barriers as crucial to increasing accessibility and reducing reliance on imports. As more companies enter the sector, Getasew expects technological advancements that will broaden the range of domestically produced medical equipment.
He also highlighted the potential for lower-priced medical devices to lead to cost savings, improved health outcomes, higher customer satisfaction, and enhanced operational efficiency. Getasew is confident that quality will not be compromised, citing the Authority's multidisciplinary assessments and robust quality control systems. He also recommends that insurers establish dedicated departments to monitor the quality and efficacy of medical devices, providing an additional layer of oversight.
PUBLISHED ON
Aug 11,2024 [ VOL
25 , NO
1267]
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