The Evolving Landscape of Medical Device Regulation in East, Central, and Southern Africa.
The Evolving Landscape of Medical Device Regulation in East, Central, and Southern Africa.
复制标题
DOI：
10.9745/ghsp-d-20-00578
复制
发表时间：
2021-03-31
期刊：
影响因子：
--
通讯作者：
Fitzgerald TN
中科院分区：
文献类型：
--
作者：
Hubner S;Maloney C;Phillips SD;Doshi P;Mugaga J;Ssekitoleko RT;Mueller JL;Fitzgerald TN
大多数现有的医疗设备都不是为应对许多非洲国家经常面临的挑战而制造的。医疗器械的监管体系对于确保器械的安全性和有效性至关重要。然而，目前，大多数非洲国家没有一个明确的监管程序。这阻碍了非洲国内的创新者和非洲以外的公司开发适合这些挑战的高质量医疗设备。尽管东非、中非和南部非洲外科医师学会的14个成员国中有11个国家有立法规定对医疗器械进行监管，但目前只有一半的国家正在制定医疗器械监管程序，一半的国家没有正式程序。一个国家的国内生产总值与医疗器械监管水平有很强的相关性。从该国独立到现在所经过的年数与该国监管进程的状况密切相关。在制定或创建新的医疗器械法规时，为了扩大监管能力并最大限度地减少资源消耗，政策制定者应促进通过或修订现有的协调一致的法规。卫生部应将地方能力建设放在优先位置，以训练有素的人员、工具和设施的形式提高监管标准。拥有慈善部门的医疗技术公司应该考虑投资于能力建设和创新，以协调非洲各国的监管标准。与国际标准相协调的有效监管框架对于扩大中低收入国家获得优质医疗器械的机会至关重要。本综述概述了东部、中部和南部非洲外科医师学会(COSECSA)和南非14个成员国的医疗器械监管状况。根据管制建立程度对各国进行了分类，发现管制水平与国内生产总值(国内生产总值；rS=0.90)和免于殖民的年限(rS=0.60)呈正相关，与人均国内生产总值(rS=0.40)的正相关程度较低。尽管大多数国家在国家立法中强制要求对医疗器械进行监管，但很少有国家采用世界卫生组织制定的所有指导方针。对于寻求将医疗器械带入非洲市场的创新者来说，简化整个非洲国家的监管流程将简化这一过程，从而增加患者获得安全医疗器械的机会。
Most existing medical devices were not built for the challenges often present in many African countries. Regulatory systems for medical devices are essential to ensuring device safety and efficacy. Yet, currently, most African countries do not have a well-defined regulatory process. This discourages both innovators within Africa and companies outside of Africa from developing quality medical devices suitable for these challenges. Although 11 of 14 member countries of the College of Surgeons of East, Central, and Southern Africa have legislation mandating the regulation of medical devices, only half are currently developing medical device regulatory processes and half do not have a formal process. A country's gross domestic product had a strong correlation to level of medical device regulation. The number of years that had elapsed from the country's independence to the present had a strong correlation to the status of the country's regulatory processes. To expand regulatory capacity and minimize resource expenditure when developing or creating new medical device regulations, policy makers should facilitate adopting or amending existing harmonized regulations. Ministries of health should prioritize local capacity building in the form of well-trained personnel, tools, and facilities to improve regulatory standards. Medical technology companies with a charitable division should consider investment in capacity building and innovation to harmonize regulatory standards across African countries. Effective regulatory frameworks, harmonized to international standards, are critical to expanding access to quality medical devices in low- and middle-income countries. This review provides a summary of the state of medical device regulation in the 14 member countries of the College of Surgeons of East, Central, and Southern Africa (COSECSA) and South Africa. Countries were categorized according to level of regulatory establishment, which was found to be positively correlated to gross domestic product (GDP; rs=0.90) and years of freedom from colonization (rs=0.60), and less positively correlated to GDP per capita (rs=0.40). Although most countries mandate medical device regulation in national legislation, few employ all the guidelines set forth by the World Health Organization. A streamlined regulatory process across African nations would simplify this process for innovators seeking to bring medical devices to the African market, thereby increasing patient access to safe medical devices.