A Brief Discussion on the in Vitro Diagnostic Reagent Inspection Practice of Self-examination Management Regulations for Medical Device Registration / 中国医疗器械杂志

On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.

Vacunas anti COVID-19: una mirada desde la perspectiva reguladora / Anti-COVID-19 vaccines: a look from the regulatory perspective

El desarrollo de vacunas contra la COVID-19 ha constituido una de las principales prioridades de la comunidad científica global. Hasta la fecha, múltiples vacunas han sido aprobadas para uso por numerosos países y la Organización Mundial de la Salud ha incluido algunas de estas en su programa de listado de uso de emergencia. El presente trabajo ofrece información sobre estos aspectos y analiza el reto colosal que ha representado para el sector regulatorio enfrentarse al creciente desarrollo de vacunas contra la COVID-19, asegurando su calidad, seguridad y eficacia. De igual forma, se abordan los nuevos enfoques en el desarrollo de los ensayos clínicos, o modificaciones en los procedimientos regulatorios existentes, que han sido cuidadosamente adaptados por las agencias reguladoras, sin perder su capacidad de escrutinio y la integridad de la evaluación científico-regulatoria(AU)

The development of anti-COVID-19 vaccines has been one of the main priorities of the global scientific community. To date, multiple vaccines have been approved for use by numerous countries, and the World Health Organization has already included some of these in its emergency use listing program. This paper offers information on these aspects and analyzes the colossal challenge that facing the growing development of vaccines against COVID-19 has represented for the regulatory sector, ensuring their quality, safety and efficacy. Similarly, new approaches in the development of clinical trials are addressed, or modifications in existing regulatory procedures that have been carefully adapted by regulatory agencies, without losing their scrutiny capacity and the integrity of the scientific-regulatory evaluation(AU)

Research on the Necessity and Feasibility of Current Medical Device Supervision Legislation / 中国医疗器械杂志

This paper studies the necessity of the current legislation on the supervision of medical devices in China from the perspectives of strengthening administration according to law, protecting public health, perfecting the legal system of medicine and promoting the development of the medical device industry. This study analyzes and summarizes the legislative experiences and forms in the field of medical device regulation in the United States, the European Union, Japan and other countries and regions, at present, the conditions of carrying out the legislation of medical device supervision in China are quite mature, and some policy suggestions are put forward for the enactment of the law of medical device management in China.

Etat des lieux de la règlementation des essais cliniques au Mali / State of play of the regulation of clinical trials in Mali

Objectif: L'objectif était de réaliser l'état des lieux de la réglementation des essais cliniques au Mali. Matériel et Méthodes: Il s'agissait d'une étude transversale descriptive réalisée du 1er septembre au 15 décembre 2019. Elle a consisté en une recherche documentaire et une enquête de terrain dans les centres de recherche, les comités d'éthique et les structures règlementaires du Mali. Résultats: En 2019, il y a eu 15 essais cliniques autorisés et réalisés par trois centres de recherche, dont 12 vaccinaux et 3 médicamenteux tous approuvés par un comité d'éthique. Le cadre juridique des essais cliniques est régi au Mali par deux textes dont l'un législatif et l'autre réglementaire. Ils prévoient l'autorisation, la suspension ou l'interdiction de la recherche biomédicale par le ministre en charge de la santé. Les insuffisances recensées sont relatives à la faible remontée et au manque d'évaluation des données de pharmacovigilance, la rareté des inspections des sites et surtout l'absence de comité technique d'évaluation règlementaire des dossiers à la Direction de la Pharmacie et du Médicament (DPM). Conclusion: Le renforcement du cadre juridique est, plus que jamais, nécessaire pour assurer la protection des droits, la sécurité et le bien-être des sujets de recherche dans un contexte de délocalisation croissante des essais cliniques vers nos pays

Objective: The objective was to take stockof the regulation of clinical trials in Mali. Material and Methods: This was a descriptive cross-sectional study carried out of the September 1 to December 15, 2019. It consisted of a literature search and a survey in research centers, ethics committees and regulatory structures in Mali. Results: In 2019, there were 15 clinical trials authorized and conducted by three research centers, including 12 vaccines and 3 drugs trials all approved by an ethics committee. The legal framework for clinical trials is governed in Mali by two texts, one legislative and the other regulatory. They provide for the authorization, suspension or prohibition of biomedical research by the minister in charge of Health. The shortcomings identified relate to the low recovery and lack of evaluation of pharmacovigilance data, the scarcity of site inspections and especially the absence of a technical committee for regulatory evaluation of files at the Pharmacy and Medicines Department (DPM). Conclusion: The strengthening of the legal framework is, more than ever, necessary to ensure the protection of the rights, safety and well-being of research subjects in a context of increasing relocation of clinical trials to our countries

Regulación de dispositivos médicos en el contexto de COVID-19 / Regulation of medical devices in the context of COVID-19

El IMDRF es un grupo voluntario de reguladores de dispositivos médicos de todo el mundo que se han unido con el objetivo de acelerar la armonización y convergencia reguladora internacional de dispositivos médicos. Los miembros actuales son Australia, Brasil, Canadá, China, la Unión Europea, Japón, Rusia, Singapur, Corea del Sur y Estados Unidos de América quienes cuentan con sistemas regulatorios consolidados para dispositivos médicos

A implantação do Núcleo Interno de Regulação em Hospital Público Terciário ­ A experiência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo / Implementation of the Internal Regulation Committee in a Tertiary Public Hospital ­ The experience of General Hospital of Ribeirão Preto Medical School of the University of São Paulo

RESUMO Introdução: O Núcleo Interno de Regulação (NIR) é uma das estratégias de gestão criadas pela Política Nacional de Atenção Hospitalar do Ministério da Saúde em 2013. Visa a organização do acesso à consultas, serviços diagnósticos e terapêuticos e aos leitos de internação, sendo fundamental o conhecimento do perfil epidemiológico e ajuste de seus processos de trabalho de modo a garantir o fluxo no sistema de saúde. Como as normas para implantação só foram realizadas em 2018, vários serviços implantaram o NIR sem diretrizes e há necessidade de se avaliar o grau de implantação. Objetivo: Avaliar o nível de implantação do NIR em duas unidades de um complexo hospitalar público terciário. Metodologia: Estudo de avaliação, exploratório, descritivo e longitudinal, realizado em duas unidades de internação hospitalar público terciário implantadas no primeiro semestre de 2016 (Unidade de Emergência) e no primeiro semestre de 2017 (Unidade Campus). Resultados: Devido à natureza de sua vocação (eletivo ou urgência), observou-se perfil epidemiológico distinto nas unidades, embora tenha sido possível a construção de processo e análise de SWOT integrada para efeitos de tomada de decisão e planejamento. De acordo com os pilares propostos pelo Manual, ambas em maior ou menor grau apresentam iniciativas recomendadas. Mas, por outro lado, os entrevistados reforçam a necessidade de maior investimento para aprimorar o processo. Conclusão: É necessário o estabelecimento de uma política de implantação dos NIR's com referenciais objetivos que possam ser pontuados e permitam o acompanhamento temporal do seu desenvolvimento. (AU)

ABSTRACT Introduction: The Internal Regulation Committee (IRC) is one of the management strategies created by the National Health Care Policy of the Ministry of Health in 2013. It aims to organize the access to consultations, diagnostic and therapeutic services and to hospital beds. It is necessary to know the epidemiological profile to adjust its processes to guarantee the flow in the healthcare system. As the standards for implementation were only established in 2018, several services implemented the ICR without guidelines, and there is a need to evaluate the degree of implementation. Objective: To evaluate the level of NIR implantation in two units of a public tertiary hospital complex. Methodology: Exploratory, descriptive and longitudinal study, carried out in two tertiary public hospitalization units implanted in the first half of 2016 (Emergency Unit) and the first half of 2017 (Campus Unit). Results:Due to the nature of their vocation (elective or emergency), a distinct epidemiological profile was observed, although it was possible to construct an integrated SWOT process and analysis for decision--making and planning purposes. According to the principles proposed by the Manual, both presented recommended initiatives to a greater or lesser degree. However, on the other hand, the units inter-viewed reinforce the need for more investment to improve the process. Conclusion: It is necessary to establish a policy for the implementation of NIRs with objective checklists that can be set and allow the temporal monitoring of their development (AU)

Gravity of the non-authorized use of substances not intended for clinical use in invasive aesthetic procedures: the portuguese case

SUMMARY INTRODUCTION: There is a worldwide increase in the number of invasive aesthetic procedures, and there is a general apprehension in medical societies towards the assurance of patient safety, that is dependent on the quality and certification of providers, of the materials and substances used, and where they take place. It is the main objective of this study to determine the perception of the gravity of non-authorized substances for clinical use in invasive aesthetic procedures among Portuguese plastic surgeons and its variation by the clinical sector of practice. METHODS: We proceeded to an inquiry by using a questionnaire, measured in a Linkert scale, and the collected data were statistically treated with a non-parametric Kruskal-Wallis test. RESULTS: We obtained a 41,4% answer rate and a global perception that this is a serious problem - a median of 8,00 and mean of 7,45 points on a 1 to 10 scale. 70% of the plastic surgeons that answered the questionnaire work both in the private and public sector, 19% exclusively in the public sector and 11% only in private practice. The perception of the problem was most serious among those that work exclusively in the private sector (statistically significant difference). CONCLUSION: The causes of the observed difference may reside in various reasons: the higher number of patients submitted to invasive aesthetic procedures exclusively in private practice; the higher perception of regulatory deficits in the private sector; scarce specific health politics for procedures outside the traditional boundaries of medicine; the difficulty for independent regulatory agencies to adopt effective measures.

RESUMO INTRODUÇÃO: Os procedimentos estéticos invasivos estão a aumentar globalmente, e são acompanhados por uma apreensão das sociedades médicas sobre a segurança desses procedimentos, dependentes da qualidade e certificação dos prestadores, dos dispositivos e substâncias utilizados e do local onde são efetuados. O presente estudo procura aferir a percepção dos cirurgiões plásticos portugueses sobre a gravidade da utilização de substâncias não autorizadas para uso clínico em procedimentos estéticos, e a sua variação consoante o setor em que exercem a atividade clínica. MÉTODOS: Foi utilizado um inquérito sob a forma de questionário, medido numa escala de Likert, e os dados foram tratados estatisticamente pelo teste não paramétrico de Kruskal-Wallis. RESULTADOS: Obteve-se uma taxa de resposta de 41,4% e a perceção global é a de que o problema é grave — mediana de 8,00 e média de 7,45 numa escala de 1 a 10. Setenta por cento dos cirurgiões plásticos que responderam ao inquérito trabalham num regime misto, 19% exclusivamente no setor público e 11% apenas no setor privado. A percepção do problema como mais grave (diferença estatisticamente significativa) foi observada na atividade exclusiva no setor privado. CONCLUSÕES: A diferença observada pode dever-se a vários fatores: à maior observação de pacientes submetidos a esses procedimentos exclusivamente no setor privado; à maior percepção de déficits de regulação no setor privado; ao déficit de políticas de saúde específicas a técnicas utilizadas fora do contexto tradicional da medicina; à dificuldade de as agências administrativas reguladoras independentes adotarem práticas efetivas no setor privado da saúde.

Concept of Smart Regulation on Medical Devices under New Situation / 中国医疗器械杂志

The traditional regulation mode on medical devices has invalid and negative effect problems. In order to more effectively ensure safety and efficacy of medical devices, promote healthy industrial development, this paper puts forward the innovative concept of smart regulation on the basis of problem orientation. Compared with traditional regulatory mode, smart regulation focus on effectiveness, and pays attention to relationship between effective regulation with self-discipline and industrial development, has characteristics of improving pertinence, effectiveness, accuracy, speed and efficiency of regulation. This paper further elaborates implementation approaches and attentions of smart regulation, by the ways of strengthening credit management, intelligent regulation, professional regulation, promoting self-discipline and encouraging innovation.

A evolução da regulamentação técnica na qualidade das bolsas plásticas utilizadas na coleta de sangue no Brasil / The evolution of technical regulation for the quality of plastic bags used in the blood collection in Brazil

O Instituto Nacional de Controle de Qualidade em Saúde é uma unidade de referência no controle da qualidade em bolsas de sangue. A legislação vigente que descreve este controle é a RDC n° 35/2014 da Agência Nacional de Vigilância Sanitária/Ministério da Saúde, que substituiu a Portaria SVS/MS n° 950/1998 (Secretaria de Vigilância Sanitária/Ministério da Saúde). Os objetivos deste estudo foram avaliar os avanços técnico-científicos no controle da qualidade e propor novas metodologias. Primeiramente, foram comparadas as metodologias e as técnicas recomendadas, para, em seguida, apresentar novos estudos. Na comparação, foram observados os avanços referentes à preocupação da manutenção das colunas cromatográficas e reprodutibilidade de resultados. As metodologias foram desenvolvidas, otimizadas e validadas buscando-se eficiência e robustez. Das onze metodologias, cinco foram alteradas e discutidas neste estudo. Para nova atualização da legislação, estão em tramitação o desenvolvimento de uma metodologia para determinação de teor de citrato e fosfato, avanços em estudos do pH, além de duas metodologias propostas para determinação do principal contaminante. Este estudo apresentou a evolução nos parâmetros da qualidade e evidenciou a importância do Instituto como ente do Sistema Nacional de Vigilância Sanitária e na atualização das questões regulatórias.

The National Institute of Health Quality Control is a reference unit for the quality control of bloodcollecting bags. The current legislation that describes this control is RDC No 35/2014 of National Health Surveillance Agency/Ministry of Health, which replaced the Order SVS/MS N° 950/1998 (Secretariat of Health Surveillance/Ministry of Health). The objectives of this study were to evaluate the technical-scientifical advances in the quality control and to propose the new methodologies. Firstly, the recommended methodologies and techniques were compared; then the new studies were presented. In the comparison study, the progresses were observed regarding the maintenance of the chromatographic columns and the reproducibility of results. The methodologies were developed, optimized and validated looking for the efficiency and robustness. Of eleven methodologies, five were changed and they were discussed in this study. For the further legislation updating, the development of a methodology for determining citrate and phosphate contents, the advances in pH studies, and besides the two proposed methodologies for detecting the main contaminant are underway. This study presented the evolution in the quality parameters and evidenced the importance of Institute as part of the National Sanitary Surveillance System and in the regulatory issues updating.

Declaración de la Academia Chilena de Medicina sobre el Título V de la Ley 20. 850 (Ley Ricarte Soto) y su proyecto de reglamento “De los ensayos clínicos de productos farmacéuticos y elementos de uso médico” / Declaration of the Chilean Academy of Medicine of Law 20. 850 On clinical trials of pharmaceutical products and medical devices” and of the bylaw that will regulate its application

In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1. The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2.The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3. Individuals submitted to the trials are entitled to free post trial access to the treatment received during the study, financed by the trial supporting entities and as long as the drug or devise is considered to be useful. While agreeing with the need to have a National Registry of Clinical Trials, we predict that the mentioned critical issues in the bylaw will lead to difficulties and unnecessary judicial processes, thus limiting clinicians’ interest in performing research. We propose to modify the bylaw, excluding responsibilities on events associated with the natural evolution of the medical condition, with patients’ ageing or with comorbidities and clinical events considered unpredictable when the protocol was accepted. We recommend that the free post trial access should be a joint decision involving the patient and the attending physician, taking in consideration that the volunteer has been exposed to risks and burdens, or when discontinuation of treatment entails a vital risk until the treatment under study has been approved and becomes available in the national market.

Situación de la regulación de los dispositivos médicos en la Región de las Américas / Regulation of medical devices in the Region of the Americas

RESUMEN Objetivo Describir y analizar la situación actual y los desafíos de la regulación de dispositivos médicos en la Región de las Américas, así como presentar los resultados del Mapeo Regional, los avances en la construcción de indicadores avanzados de evaluación y los logros obtenidos por el Grupo de Trabajo Regional. Métodos Elaborar un perfil regional sobre la regulación de dispositivos médicos en las Américas es una prioridad del Grupo de Trabajo. Para ello, se desarrolló una herramienta de evaluación integrada por 45 preguntas organizadas en seis secciones, que se distribuyó en 15 países para su autoevaluación (la tasa de participación fue 100%). A partir de los datos recibidos se establecieron nueve indicadores básicos y se acordó el desarrollo de indicadores avanzados para medir el nivel de implementación de los programas regulatorios de dispositivos médicos. Resultados El 93% de 15 países cuenta con una institución responsable de la regulación de dispositivos médicos. Al analizar el desempeño por país, se observa variabilidad: desde países que cumplen todos los indicadores, hasta aquellos que únicamente cumplen 11%. El mapeo también permitió generar información sobre alianzas colaborativas, capacitación y reglamentación. Conclusiones Los resultados muestran una heterogeneidad significativa a nivel regional. La implementación de indicadores avanzados contribuirá a identificar áreas de oportunidad y fortalezas para la creación del perfil regulatorio. Aunque se ha avanzado en el fortalecimiento de los programas regulatorios de dispositivos médicos, aún hay brechas que deben reducirse mediante estrategias e iniciativas que serán lideradas por el Grupo de Trabajo.

ABSTRACT Objective To describe and analyze the current status of and the challenges involved in the regulation of medical devices in the Region of the Americas and to present the results of the regional mapping exercise, progress toward the development of advanced assessment indicators, and the achievements of the Regional Working Group. Methods Creating a regional profile on the regulation of medical devices in the Americas is a priority for the Working Group. To this end a tool composed of 45 questions organized into six sections was developed and distributed among 15 countries for self-assessment (the participation rate was 100%). Based on the data received, nine basic indicators were established and an agreement was reached to develop advanced indicators for measuring the extent to which regulatory programs for medical devices were being implemented. Results Of the 15 countries, 93% have an agency in charge of regulating medical devices. An analysis of individual country performance shows wide variability, with some countries meeting all indicators and others meeting as few as 11%. The mapping also made it possible to generate information on collaborative partnerships, training, and regulation. Conclusions The results show significant heterogeneity at the regional level. Implementation of advanced indicators will help to identify areas of opportunity and strengths for the development of the regulatory profile. Although progress has been made toward strengthening regulatory programs for medical devices, remaining gaps need to be bridged through strategies and initiatives to be led by the Working Group.

Recopilación de las disposiciones reguladoras de equipos médicos, aprobadas en el período 2008-2015 / European provisions governing medical devices approved in the period 2008-2015

Las acciones tomadas han permitido, gradualmente, la actualización del Programa Regulador de Equipos Médicos, lográndose al unísono dar cumplimiento a la estrategia de desarrollo de dicho programa mediante la implementación de los documentos técnicos y legales que lo componen y por ende el incremento de la cultura reguladora en Cuba. Este libro se presenta el resultado de la incesante labor de los especialistas del CCEEM, que han trabajado arduamente para lograr la actualización de los documentos regulatorios complementarios al Reglamento y ahora lo ponemos a disposición de todos los interesados, como una herramienta de obligada consulta.