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Document No. : FDA/SMC/CTD/GL-CCT/2013/01
Rwanda: FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES
MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES | Official Gazette nº 46 of 13/11/2017
The occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while focusing on counterfeit medicines and medical device
...
s in developing countries, will present information on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world.
more
Emergency medical teams (EMTs) play an important role in strengthening health service networks in terms of their strategies and tactics for planning mass vaccination programs, especially in remote or under-resourced areas or those overwhelmed by COV
...
ID-19. EMTs experience deploying in remote areas and handling operational challenges to ensure their response even under the most austere conditions will be of great support in facing the technical and logistical challenges to timely and equitable access to vaccines at the local level.
more
Decontamination of medical devices plays an important role in the prevention of health care-associated infections. It includes cleaning, disinfection and/or sterilization. The processes involved in decontamination are complex, require specific infra
...
structure and equipment, and involve several sequential steps that need to be performed correctly – from device collection and receipt by the decontamination unit to processing, storage and distribution throughout the facility. Quality control procedures (such as validation) at each step of the decontamination process are of the utmost importance to ensure the correct functioning of the equipment and processes. This aide-memoire presents a concise overview of important advice and key elements at a glance.
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Global Atlas of medical devices 5 August 2017
WHO medical devices technical series
The Protection of Personal Information (POPI) Act
Confidentiality: providing and protecting information
• Health care practitioners hold information about patients that is private and sensitive.
• The National Health Act (Act No. 61 of 2003) provides that this information must not be given to
...
others, unless the patient consents or the health care practitioner can justify the disclosure.
• Practitioners are responsible for ensuring that clerks, receptionists and other staff respect confidentiality in their performance of their duties.
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A Training Course for Service Providers
23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeter
...
s, patient monitors, thermometers, infusion and suction pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
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Heart failure with a reduced ejection fraction (HFrEF) is a condition frequently encountered by healthcare professionals and, in order to achieve the best outcomes for patients, needs to be managed optimally. This guideline document is based on the European Society of Cardiology Guidelines for the t
...
reatment of acute and chronic heart failure published in 2016, and summarises what is considered the best current management of patients with the condition. It provides information on the definition, diagnosis and epidemiology of HFrEF in the African context. The best evidence-based treatments for HFrEF are discussed, including established therapies (beta-blockers, ACE-i/ARBs, mineralocorticoid receptor antagonists (MRAs), diuretics) that form the cornerstone of heart failure management as well as therapies that have only recently entered clinical use (angiotensin receptor-neprilysin inhibitor (ARNI), sodium/glucose cotransporter-2 (SGLT2) inhibitors). Guidance is offered in terms of more invasive therapies (revascularisation, implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) by implantation of a biventricular pacemaker with (CRT-D) or without (CRT-P) an ICD, left ventricular assist device (LVAD) use and heart transplantation) in order to ensure efficient use of these expensive treatment modalities in a resourcelimited environment. Furthermore, additional therapies (digoxin, hydralazine and nitrates, ivabradine, iron supplementation) are discussed and advice is provided on general preventive strategies (vaccinations). Sections to discuss conditions that are particularly prevalent in sub-Saharan Africa (HIV-associated cardiomyopathy (CMO), peripartum CMO, rheumatic heart disease, atrial fibrillation) have been added to further improve clinical care for these commonly encountered disease processes.
more
GDF is the largest global provider of quality-assured tuberculosis (TB)
medicines, diagnostics, and laboratory supplies to the public sector.
Since 2001, GDF has facilitated access to high-quality TB care in over 130
countries, providing treatments to over 30 million people with TB and procuring
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and delivering more than $200 million worth of diagnostic equipment
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A Training Course for Service Providers
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