Dissertations / Theses on the topic 'Regulation of medicines and medical devices'

Medical devices are becoming more important in the health care sector. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union.

The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. A company goes far by following the requirements in EU, USA or the GHTF guidelines.

Остап'юк М. В. Господарсько-правове регулювання державних закупівель лікарських засобів та медичних виробів : дис. ... канд. юрид. наук : спец. : 12.00.04 / Остап'юк Марія Василівна. - Одеса, 2015. - 229 арк
Дисертація є комплексним, системним дослідженням, присвяченим господарсько-правовому регулюванню державних закупівель лікарських засобів та медичних виробів, та пошукам шляхів його удосконалення. Досліджено та визначено історико-правові засади генези державних закупівель лікарських засобів та медичних виробів, системи нормативноправових актів з цього питання, сутність державних закупівель лікарських засобів та медичних виробів, коло суб’єктів, їхню компетенція та види господарських відносин. Визначено правові вимоги до предмета закупівлі та етапи його визначення, стадії здійснення державних закупівель, характерні виключно для цієї сфери закупівель; напрями удосконалення господарськоправового регулювання закупівлі лікарських засобів і медичних виробів за рамковими угодами та відповідальності постачальників за розірвання договорів про закупівлю у цій сфері. Розроблено низку проектів нормативно-правових актів, змін та доповнень до законодавства, що регулює ці відносини.
Диссертация является специальным комплексным исследованием, посвященным хозяйственно-правовому регулированию государственных закупок лекарственных средств и медицинских изделий в Украине и поискам путей его усовершенствования. Исследованы историко-правовые основы генезиса государственных закупок лекарственных средств и медицинских изделий и определена их периодизация. Рассмотрено систему нормативно-правовых актов, регулирующих правоотношения в этой сфере и определено общее и специальное законодательство. Осуществлена детализацию социальных потребностей в товарах, работах и услугах через выделение потребностей государства и территориальной общины в закупке лекарственных средств и медицинских изделий, вытекающие из потребностей человека в лечении. Рассмотрены преимущества и недостатки централизованной и децентрализованной закупки лекарственных средств и медицинских изделий и высказана целесообразность разграничения направлений закупки в централизованном и децентрализованом порядке. Охарактеризован субъектный состав государственных закупок лекарственных средств и медицинских изделий, в связи с чем, дополнена существующая в научной доктрине классификация субъектов правоотношений в сфере государственных закупок путем выделения специализированных организаций, осуществляющих закупки. Разработан План мероприятий по усилению конкуренции в сфере государственных закупок лекарственных средств, который включает мониторинг и развитие производства лекарственных средств, аналоги которых отсутствуют на рынке Украины, а также международное сотрудничество и инвестирование в этом направлении. Предложено определение государственных закупок лекарственных средств и медицинских изделий. Акцентируется внимание на отсутствии нормативно-правового акта или иного документа, которым регламентируется формирование требований к лекарственным средствам и медицинским изделиям как к предмету закупки. Проведено исследование документаций конкурсных торгов в этой сфере, анализ законодательства, регулирующего их оборот и доказано, что правовые требования, которые формируются к лекарственным средствам и медицинским изделиям как к предмету закупки зависят от особенностей их правового регулирования. Предложено разделение их на общеобязательные и специально-обязательные. Впервые разработаны Рекомендации для заказчиков по формированию требований к лекарственным средствам и медицинским изделиям как к предмету закупки. Исследована специфика определения предмета закупки в сфере государственных закупок лекарственных средств и медицинских изделий и установлены этапы его осуществления. Определены стадии государственных закупок, свойственные только для сферы государственных закупок лекарственных средств и медицинских изделий, дана им характеристика. Впервые выявлены проблемы осуществления закупки лекарственных средств и медицинских изделий по рамочным соглашениям и разработаны конкретные предложения относительно усовершенствования хозяйственноправового регулирования в этой сфере. Разработаны особенности исполнения рамочных соглашений в сфере государственных закупок лекарственных средств и медицинских изделий, предусматривающие непрерывное обеспечение потребностей государства и территориальной общины в лекарственных средствах и медицинских изделиях путем заключения договоров о закупке не менее чем с двумя участниками рамочного соглашения, заключенного на несколько лет. Предложено введение в научный и законодательный оборот термина «договор о закупке по рамочному соглашению» и дано его определение. Проанализированы последствия расторжения договоров о закупке лекарственных средств и медицинских изделий и даны предложения по установлению хозяйственно-правовой ответственности поставщиков за совершение этих действий в виде штрафа, а также предложено запретить 20 расторжения их в случае отсутствия времени, достаточного для проведения повторной процедуры государственных закупок. С целью усовершенствования хозяйственно-правового регулирования государственных закупок лекарственных средств и медицинских изделий, разработан проект Плана мероприятий для усиления конкуренции в сфере государственных закупок лекарственных средств, проект Рекомендаций по формированию требований к лекарственным средствам и медицинским изделиям как к предмету закупки, проект постановления Кабинета Министров Украины «Об особенностях исполнения рамочных соглашений в сфере государственных закупок лекарственных средств и медицинских изделий», а также ряд изменений и дополнений в акты законодательства, регулирующие эти отношения.
The legal and historical foundations of the Genesis of public procurement of medicines and medical products, the system of normative-legal acts on the matter, the essence of public procurement of medicines and medical devices, a range of actors, their competence and the types of business relationships have been researched and determined. Author has defined legal requirements for the subject procurement and the stages of its definition, the implementation phase of public procurement, unique to this area of procurement; directions of improvement of economic-legal regulation of the procurement of medicines and medical devices under framework agreements and the liability of the suppliers for cancellation of contracts to purchase in this area. Author has proposed a number of draft legal acts, amendments and additions to legislation regulating these relations.

Medical products of all kinds have to comply with regulations to satisfy the demand for public health and safety. Medicinal products (drugs) were the first medical products to be regulated in most countries and regulations for medical devices - generally derived from drug regulations - followed. This thesis reviews the development of safety regulation for medical devices from its relatively recent introduction in the 1960s to the present day. The emphasis is on the situation in countries of the European Community but events in these countries are placed in a world-wide context. Landmark events in this process - notably the US Medical Device Amendments of 1976 and the EC Medical Device Directive of 1994 - are analysed and compared. An examination of current regulations in the three major markets for medical devices: Europe, Japan and USA, leads to the identification of quality systems, product standards, effectiveness/performance and post-market controls as key factors in modern regulatory approaches. The emergence of these key factors illustrates the movement towards an engineering, rather than a pharmaceutical, approach to regulation and their place in current and emerging regulations world-wide is discussed. Manufacturers have long pressed for uniformity in national regulations to reduce the time and cost involved in obtaining market approval and their case has been largely accepted by the regulatory authorities. Harmonization in Europe has been achieved as part of the Single Market programme. The last decade has seen remarkable progress towards the further harmonizing of national and regional regulations. The outstanding difficulties, notably controversy over the need for "effectiveness" determination and relative roles of clinical and laboratory testing, are discussed and solutions proposed. The prospects for achieving global harmonization are examined and a possible future global system is described.

The thesis is focused on theoretical principles of demarcation of products with health effects in the EU law and on the reflection of these issues in the application and administrative practice in commercial law. The thesis developed yet been brought judicial interpretation with the scientific interpretation of certain key and decisive problems that separate from each other law-regimes of regulation: medicinal product for human use, foods, cosmetics products, medical devices and biocides. Correct law-regime for a particular product is determinating of the general legal basis in the EU internal market. It is therefore a important problem not only in EU law, but also in EU economic. Thesis results are highly critical of current practice in the local markets of EU member states, especially Czech Republic, and in many instances documented sub-optimal application of this law in general practice.

On the 26th of May 2021 the new regulation for medical devices, MDR 2017/745, will come into force. The underlying incentives to go from the medical device directive (MDD 93/42/EEC) to MDR are a series of adverse events involving medical devices. The main goal of MDR is to strengthen and improve the already existing legislation and thus will entail large changes for manufactures, one of them being manufacturers of Electronic Health Record (EHR) systems. For medical software, such as EHR systems, the new regulation will imply an upgrade in risk classification. This upgrade will bring additional requirements for EHR manufacturers. Furthermore, the released guidelines have been insufficient regarding the specific requirements for medical device software and thus EHR manufacturers are in need of tools and guidance to fulfill MDR. This thesis examines the new regulation for medical devices and thus identifies main requirements for EHR manufacturers. A qualitative approach was conducted comprising a literature study as well as a document study of the medical device regulation along with interviews with experts within the field of medtech regulatory affairs and quality assurance. The information gathered was analyzed to create a process description on how EHR manufacturers are to fulfill MDR. The process description is a general outline and presents the main steps on the route to be compliant with MDR in a recommended order of execution. The main steps are: divide the system into modules, qualify the modules, classify the modules, implement a quality management system, compile a technical documentation, compile the declaration of conformity, undergo a conformity assessment and finally, obtain the CE-mark. To each of the main steps additional documentation provides further information and clarification. The process description functions as a useful tool for EHR manufacturers towards regulatory fulfillment. Even though the process description is created for EHR manufacturers, it can be useful for other medical device software manufacturers. The process description provides an overview of the path to a CE mark and functions as a guidance. It can be used in educational purposes as well as to serve as a checklist for the experienced manufacturer to make sure everything is covered. However, it is not sufficient to rely solely on the process description in order to be in full compliance with MDR. Moreover, there is still a need for further clarifications from the European Commission regarding specific requirements on medical device software.

The medical device regulatory system, as well as the medical device market in the European Union (EU), is now facing challenges posed by the newest regulation, Medical device regulations (MDR). Researches have shown concerns and possible consequences related to this new regulation system from both the regulatory approval procedure and market development perspectives. This study aims to elaborate on a practical and objective situation of this latest shift and picture out a predictable scenario for the implementation of future technology like Additive Manufacturing (AM) in healthcare. These two objectives are addressed from the perspective of the core role in this system, Notified Bodies (NBs). Specifically, it answers the following questions: What is the impact of the MDR on the NBs’ operations? What is the impact of the MDR on the device building on AM from NBs’ perspective? A literature review is conducted on existing researches in the relevant fields mentioned in the research questions of this study. Then a self-completion questionnaire is generated and sent to NBs who offer the CE marking granting service for the medical devices around the EU. The eight responses for the survey indicate that the MDR influences NBs and the device building on AM from several perspectives. For the NBs, the number of NBs will decrease while the workload and new recruitment will increase. Also, the independence and competences of NBs will be improved by MDR. In the case of AM-relevant medical devices, MDR will pose specific issues on them while the market will be developed by ensuring the product quality and raising public awareness. These findings are valuable practical evidence to examine the application of MDR and the implementation of technology like AM in healthcare under MDR. Overall, it found that the MDR will cause a tough situation in the short term. At the same time, the far-reaching influence for the regulatory system, as well as the medical device market, is affirmative and expectable worthy.

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Nanotechnology refers to the application of scientific knowledge in the control of matter at the nanoscale, in the range between 1nm and 100nm. Recent studies point to the risks that this new technology can cause to human life and to the environment, due to the insufficient knowledge of its properties and effects, being necessary the regulation of these products, their ethical implications and vigilant organs that accompany the discoveries Technological developments. Thus, this study aimed to perform an updated diagnosis based on national and international technical standards that govern the application of nanotechnology in health products through an integrative review. A total of 524 articles were found in three databases, LILACS, Scielo and PubMed, of which 61 articles were read from the final set. The methodology consisted of five steps: definition of the guiding question, search of studies in different databases, selection of studies, critical evaluation of studies and synthesis of data. The results obtained in the integrative review show that nations such as Japan, USA and of EU have demonstrated the highest level of development in nanotechnology, being representative in this study in order to compare with the advances of nanoscience in Brazil, therefore that there is no unanimous global regulation for nanotechnology worldwide, given the lack of scientific evidence regarding the risk to human health and the environment, suggesting that the regulation adopted should be based on the precautionary principle and be assessed on a case by case basis. This work served as a synthesis in the diagnosis of the needs for the construction of a regulation that is followed worldwide.
A nanotecnologia refere-se à aplicação de conhecimento científico no controle da matéria na escala nanométrica, na faixa entre 1nm e 100nm. Estudos recentes apontam para os riscos que essa nova tecnologia pode causar a vida humana e ao meio ambiente, devido ao insuficiente conhecimento das suas propriedades e efeitos, havendo a necessidade de regulamentação desses produtos, de suas implicações éticas e de órgãos vigilantes que acompanhem as descobertas tecnológicas. Assim, este trabalho teve como objetivo realizar um diagnóstico atualizado baseado nas normas técnicas nacionais e internacionais que regem a aplicação da nanotecnologia em produtos para saúde através de uma revisão integrativa. Foram encontrados 524 artigos em três bases de dados consultadas: LILACS, Scielo e PubMed sendo que, do conjunto final foram lidos incluídos neste estudo 61 artigos. A metodologia constou com cinco etapas: definição da questão norteadora, a busca dos estudos em diferentes bases de dados, a seleção dos estudos, avaliação crítica dos estudos e a síntese dos dados. Os resultados obtidos na revisão integrativa denotaram que nações como Japão, EUA e da UE demonstraram destaque com o maior nível de desenvolvimento em nanotecnologia, sendo representativas nesse estudo de forma a comparar com os avanços da nanociência no Brasil, concluindo portanto que mundialmente não existe regulação para nanotecnologia que seja unânime para todas as nações, tendo em vista a falta de comprovação científica quanto ao risco a saúde humana e ao ambiente ,sugerindo que a regulação adotada deva ser baseada no princípio de precaução e que seja avaliado caso a caso. Este trabalho serviu como uma síntese no diagnóstico das necessidades para construção de uma regulamentação que seja seguida em âmbito mundial.

Mestrado em Biomedicina Farmacêutica
The purpose of this report is to describe my experience in internship elapsed at INFARMED, I.P. in the Department of Health Products in the scope of the Master's degree in Pharmaceutical Medicine. The report is divided into an initial part where I make a general framework of the medical devices, what they are, how they are qualified/classified, how they are currently regulated and what is proposed to change. Next, I do a description of the tasks I performed and finally a discussion of the key points of these tasks.
O objetivo deste relatório é descrever a minha experiência durante o estágio decorrido no INFARMED, I.P., no Departamento de Produtos de Saúde no âmbito do Mestrado em Biomedicina Farmacêutica. O relatório é dividido por uma parte inicial na qual faço um enquadramento geral relativo aos dispositivos médicos, o que são, como são qualificados/classificados, como são regulados atualmente e o que está proposto para alteração. Depois faço uma descrição das tarefas que realizei e finalmente uma discussão dos pontos chaves dessas tarefas.

This diploma thesis deals with the topic concerning regulation of launching medical devices onto the market with regard to the analysis of key regulatory framework. The aim of the thesis is to find out if the legal framework really fulfils its de lege ferenda objectives. The purpose of this thesis is to confirm or disprove a hypothesis that the regulation of launching medical devices onto the market is sufficient and effective from the point of view of consumer protection and interests of other stakeholders. Secondary aim of this diploma thesis is to confirm or disprove a hypothesis that the harmonization of legal framework in the EU is appropriate and effective. These hypothesis are to a certain extent following up the verification of four essential goals that should be reached by the regulation. One of the key aims is assuring the safety of the products, enabling them to move freely in terms of the internal market of the EU and assuring that the consumer isn't misled when deciding about his optimal situation. Besides that the regulation shouldn't unnecessarily slow down the activities of businesses and inappropriately limit their innovation potential. The diploma thesis has a critical point of view concerning some aspects of this regulation and in the end the author suggests some proposals in order to improve the current practice.

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Este estudo analisa a regulação sanitária de equipamentos eletromédicos no Brasil e no Reino Unido. Busca identificar e analisar as semelhanças e diferenças entre os dois regimes e discutir em que medida eles protegem a saúde da população dos riscos decorrentes desses equipamentos. Optou-se por realizar pesquisa qualitativa exploratória com coleta de dados através de entrevistas, observação participante e análise de documentos, tomando-se bombas de infusão como equipamentos traçadores. Utilizando-se a Teoria dos Grupos de Interesse e a abordagem cibernética, é possível concluir que ambos os regimes estão implantados sob o modelo corporatista bipartite, priorizando a participação apenas de dois grupos de interesse, reguladores e aqueles representantes do segmento regulado. Apesar de terem legislação diferente, quanto à organização, o funcionamento deles se dá de modo fragmentado, implicando ocorrência de falhas regulatórias dos tipos captura e atenuação da ação regulatória. Têm estruturados de modo diferente os instrumentos regulatórios, controle sobre a entrada de empreendimentos no mercado, certificação de conformidade, revisão de pré-comercialização, tecnovigilância, mas guardam certa semelhança, no que diz respeito ao elemento central da ação regulatória - o equipamento em si, e não o paciente. Não utilizam os instrumentos regulatórios de forma balanceada, parecendo dar prioridade às atividades que geram recursos orçamentários para o órgão regulador e evitam conflito com o segmento regulado. Como conseqüência, aparenta que a regulação sanitária de equipamentos eletromédicos no Brasil e no Reino Unido ainda está distante de atender às necessidades de proteção da saúde da população. Para que esse objetivo seja alcançado, faz-se necessário investir em medidas educativas, esclarecendo a população sobre os riscos desses produtos e fomentando sua participação na organização do regime de regulação de risco à saúde.
Salvador

Cette thèse a pour objet l'obligation de sécurité en matière la responsabilité contractuelle à la lumière du droit français et du droit libyen. La recherche tend à répondre aux questions suivantes : Qu'entend-on par sécurité des produits médicaux ? Sur quel fondement juridique peut-on justifier cette obligation ? Quelles sont les difficultés d'application de cette obligation pour traiter les problèmes de produits de santé ? C'est quoi le produits de santé ? Et Le droit de la responsabilité civile libyen est-il parfaitement adapté à la protection de la victime des produits de santé comme dans le droit de la responsabilité français ? Ce questionnement a conduit l'auteur à développer une analyse approfondie de l'obligation de sécurité en manière de la responsabilité contractuelle et le droit de la santé français et libyen. Dans la première partie de la thèse, on constate que la notion d'obligation de sécurité, y compris en matière de la responsabilité contractuelle, a connu une évolution majeure par rapport à l'époque précédant. En fait, l'apparition de la notion d'obligation de sécurité est ancienne puisqu'elle a été créée en France le 21 novembre 1911 à l'occasion du contrat de transport. Elle peut être définie comme « l'obligation de veiller à la sécurité d'une personne ou d'un bien, qui peut être une obligation de résultat ou de moyen ». Certains codes du monde proche-oriental ont adopté la résolution que la Cour de cassation française a prise en 1911 dans le domaine du transport de personnes, comme l'Egypte et le Liban. En 1956, la Cour d'Appel à Alexandrie a conformé l'obligation de sécurité dans le domaine du transport de personnes
This thesis focuses on the safety obligation regarding contractual liability in the light of French law and Libyan law. Research tends to answer the following questions: What is safety of medical products? On what legal basis can we justify that obligation? What are the difficulties in applying this requirement to address issues of health products? What is the health products? The law and civil liability Libya is it perfectly suited to the protection of the victim of health products as in the French liability law? This questioning has led the author to develop a thorough analysis of the safety obligation by way of contractual liability and health law French and Libyan. In the first part of the thesis, we see that the notion of bond security, including with respect to contractual liability, has experienced a major change from the time before. In fact, the emergence of the concept of safety obligation is old since it was founded in France 21 November 1911 at the contract of carriage. It can be defined as "the obligation to ensure the safety of any person or property which may be an obligation of result or means." Some codes of Near Eastern world have adopted the resolution that the French Supreme Court has taken in 1911 in the transportation of persons, such as Egypt and Lebanon. In 1956, the Appeal Court in Alexandria has complied with the requirement of safety in the transportation of persons. Similarly, in Lebanon in the Code of Obligations and Contracts provides in Article 688 that the contract of carriage of persons is the responsibility of the carrier's obligation to lead the traveler, unharmed, to the destination

O Regulamento (EU) 2017/745 relativo aos dispositivos médicos entrou em vigor em maio de 2017, o que revogou a Diretiva 93/42/CEE de junho de 1993. Este novo Quadro Regulamentar Europeu manteve os princípios regulamentares básicos, promover elevados padrões de segurança e proteção da saúde e garantir o acesso atempado da inovação ao mercado. Com base no princípio máximo de saúde e segurança do doente, o Conselho e o Parlamento Europeu adotaram, a 23 de abril de 2020, o Regulamento 2020/561, que alterou o Regulamento (EU) 2017/745 sobre os dispositivos médicos no que diz respeito às datas de aplicação de algumas das suas disposições. Este adiamento de um ano, veio com o objetivo de aliviar a pressão sobre as autoridades nacionais, os organismos notificados, os fabricantes e outros intervenientes, que permite que estes se concentrem totalmente nas questões relacionadas com a pandemia do coronavírus (European Commission, 2016). Devido a dificuldades no passado, especialmente em incidentes que causaram problemas de saúde pública, este Regulamento veio reforçar áreas relevantes, como a investigação clínica, a designação e supervisão das atividades dos organismos notificados, procedimentos de avaliação de conformidade, a vigilância e fiscalização do mercado. Além deste reforço era necessário aumentar o poder de rastreabilidade em toda a cadeia de valor do dispositivo médico, possivelmente até ao doente se necessário.
The Regulation (EU) 2017/745 on medical devices took effect on May 2017, which revoked the Directive 93/42/CEE of June 1993. This new European Regulatory Frame kept the basic regulatory principles, promoting high standards of safety and health protection, and to ensure the early market access to innovation. In regard to the main principles, patient health and safety, the Council and the European Parliament adopted, in April 23 of 2020, the Regulation 2020/561, which changed the application dates, some of its provisions, from the Regulation (EU) 2017/745 on medical devices. This one year delay, came with the objective of relieving the national authorities, notified bodies, manufacturers and other actors, which allowed this parties to fully concentrate on coronavirus pandemic situation (European Commission, 2016). Due to past difficulties, especially the incidents that provoked public health issues, this Regulation came to reinforce relevant areas, such as clinic investigation, notified bodies designation and supervision, conformity evaluation procedures, and market surveillance and inspection. In addition to this reinforcement was necessary to increase the tracking capacities in all medical devices chain value, possibly until the patient if needed.

The increasing demands of the medicines and health products market leads us to think about the best form of action in order to achieve a more effective and adequate control. This dissertation deals with the regulation of health in Portugal, specifically on the regulation of the pharmaceutical sector and the role and relevance of the National Authority for Medicines and Health Products (INFARMED) as an intervening entity in the regulation and supervision of this market. The undergone study was structured into four fundamental parts. Initially a framework for the concept of economic regulation was developed, addressing the role of the State and the way in which this regulation has been developed in Portugal. We proceed to analyse the health system and the current regulatory model for this sector. In a second phase, a characterization of the pharmaceutical sector was carried out and the competences and attributions of INFARMED in the regulation and supervision of the pharmaceutical market were analyzed, with a special focus on medicines and medical devices. From this study, the fundamental variables of this dissertation were defined, namely the verification of the assumptions of independence, autonomy and accountability in the regulation exercised by INFARMED, in order to determine whether or not there is an effective risk of capture of the regulator. In a third phase, the influence of the regulatory function of the European Union and the role of the European Medication Agency (EMA) in regulating the pharmaceutical sector were studied. Finally, in a fourth step, a comparative analysis was carried out with the purpose of observing the regulation model in the United Kingdom and drawing conclusions and teachings.
As exigências cada vez maiores do mercado dos medicamentos e produtos de saúde levam a pensar sobre a melhor forma de atuação para se conseguir atingir um controlo mais eficaz e adequado. A presente dissertação versa sobre a regulação da saúde em Portugal, mais concretamente sobre a regulação do setor farmacêutico e o papel e relevância da Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED) enquanto entidade interventora na regulação e supervisão deste mercado. O estudo desenvolvido estruturou-se em quatro partes fundamentais. Numa primeira parte, foi realizado um enquadramento do conceito de regulação económica, abordando o papel do Estado e a forma como tem sido desenvolvida a regulação em Portugal. Prossegue-se com uma análise do sistema de saúde e o modelo regulatório vigente para este setor. Numa segunda fase, efetuou-se uma caraterização do setor farmacêutico e foram analisadas as competências e atribuições do INFARMED na regulação e supervisão do mercado farmacêutico, com especial enfoque para os medicamentos e dispositivos médicos. A partir deste estudo, foram definidas as variáveis fundamentais desta dissertação, nomeadamente a verificação dos pressupostos de independência, autonomia e accountability na regulação exercida pelo INFARMED, de forma a apurar se existe ou não um risco efetivo de captura do regulador. Numa terceira parte, foi estudada a influência da função reguladora da União Europeia e o papel da Agência Europeia do Medicamento (EMA) na regulação do setor farmacêutico. Por fim, numa quarta etapa, efetuou-se uma análise comparada, com o propósito de observar o modelo de regulação no Reino Unido e extrair conclusões e ensinamentos.

碩士
國立臺灣大學
國家發展研究所
106
According to Judicial Yuan Interpretation No.414, the Justices said that the level of protection to commercial advertisement was different from another types of speech, as a result, the prior restraint of medicinal advertisement was constitutional. However, many years later, the Justices made a new judicial review standard of prior restraint in Judicial Yuan Interpretation No. 744, the Justices pointed out that the prior restraint of cosmetic advertisement was a regulation that interfered the freedom of free speech seriously, and it was unconstitutional. This standard was so definitely different from the standard of Judicial Yuan Interpretation No.414, and there are many discussions based on Judicial Yuan Interpretation No. 744 after it was issued, including the discussion of the level of protection to commercial advertisements and prohibition of prior restraint. Prior restraint is a government action that may prohibit speech、publish or other expression before it can take place , and it is the most severe regulation on speech because it will lead to the consequence that speakers exercise self-censorship to avoid the punishment. As a result, in many countries, any system of prior restraint is prohibited and bear heavy presumption against its constitutionality validity, with certain limited exceptions. In other words, prior restraint is principally unconstitutional except it meets the following requirements: the clarity of law、the necessity of means and due process protection. Besides, the Justices also affirmed that prior restraint bear heavy presumption against constitutionality validity in Judicial Yuan Interpretation No. 744. However, it is a problem whether this standard is applied to another commercial advertisements case or not. Furthermore, there are other commercial advertisement regulations also in the form of prior restraint. This article focus on medicinal advertisement、medical device advertisement and medical treatment advertisement, because there are some similarity between the advertisement mentioned above and cosmetic advertisement. Through the following discussion, I try to analyze the purpose of prior restraint and whether the prior restraint of medicinal advertisement、medical device advertisement as well as medical treatment advertisement be unconstitutional under the standard of Judicial Yuan Interpretation No. 744. Keywords：Freedom of speech, commercial advertisements, prior restraints, medicinal advertisements regulations, medical devices advertisements, medical treatment advertisements

碩士
大同大學
生物工程學系(所)
100
The innovation of medicine technology enables the development of modern surgical lamp. For example,the LED lamp has replaced the traditional halogen surgical lamp.Because surgical lamp is used intensively to provide visible illumination of the surgicalfiel, shadowless or bi-lighthead illumination is required for most invasive surgery. The multi-functionality and high-performance of surgical lamp will improve the quality of surgery. However,the issues regarding safety and efficiency of surgical lamps bring more concern by international health authorities. Both internation regulation and domestic law were discussed and a regulatory framework for surgical lamp was made to supervise the manufcture of surgical lamp and to protect people’s life and safety. This study mining data from the official website of healthcare administrators around the world.The document or literature anoumced on the websites were analyzed,compared,and summarized. The findings was listed below: (1) regulation compliance is the most important part that lead surgical lamp on the market; (2) market policy should be made cautiously in the first step of product development; (3) continuously updating and adoption new regulation into quality system; (4) manufacturer must conduct post-market survillance and vigilance system; (5) chooseing in-country-representative and local distributor carefully to ensure a successful marketing.

Dissertação de mestrado em Biotechnology
Chronic wounds represent a serious health condition that affects more than 50 million people worldwide, causing a devastating impact on the well-being of the patient as well as a serious problem for the economy. Thus, this work arises from the need to find solutions that can effectively combat this problem. Here is presented a comprehensive study of the regulatory framework of medical devices, focusing on the legal requirements applicable to the development of a novel wound dressing, incorporating antimicrobial agents to treat chronic wounds, named BioMultiDress. The main goal of this thesis was to understand what are the regulatory affairs that need to be considered in order to develop such a medical device. For that purpose, it was made an analysis on the regulations of the regulatory agencies, EMA and FDA, as well as an exhaustive collection of the technical documentation applicable to the BioMultiDress, attending that this device shall be classified as a short-term class III medical device, incorporating ancillary medicinal substances, which in this case are bacteriophages. It was also performed part of the biological evaluation of the BioMultiDress, by the assessment of the bacteriophages cytotoxicity, according to the international standard ISO 10993-5. The studied phages showed no potential cytotoxic effect on BALB 3T3 cells. The knowledge and information herein compiled provides a guide to the medical devices manufacturers and regulatory authorities towards the development of such innovative medical devices as BioMultiDress. To assemble all the information, it was prepared a draft version of the BioMultiDress Design Dossier, containing the main achievements of this work.
As feridas crónicas representam uma condição de saúde grave que afeta mais de 50 milhões de pessoas por todo o mundo, causando um impacto devastador no bem-estar do doente, bem como um problema sério para a economia. Assim, este trabalho surge da necessidade de encontrar soluções que consigam efetivamente combater este problema. Aqui é apresentado um estudo compreensivo do quadro regulamentar dos dispositivos médicos, com foco nos requisitos legais aplicáveis ao desenvolvimento de um novo penso que incorpora agentes antimicrobianos para o tratamento de feridas crónicas, designado BioMultiDress. O objetivo principal desta tese foi entender quais são as questões regulamentares que precisam ser consideradas com o intuito de desenvolver um dispositivo médico desta natureza. Para tal, foi feita uma análise dos regulamentos das entidades reguladoras, EMA e FDA, bem como uma recolha exaustiva da documentação técnica aplicável ao BioMultiDress, atendendo que este dispositivo deve ser classificado como um dispositivo médico de classe III de curto prazo, incorporando substâncias médicas auxiliares, neste caso, os bacteriófagos. Também foi efetuada parte da avaliação biológica do BioMultiDress, através da avaliação da citotoxicidade dos bacteriófagos, de acordo com a norma internacional ISO 10993-5. Os fagos estudados não apresentaram nenhum potencial efeito citotóxico em células BALB 3T3. O conhecimento e a informação aqui compilados fornecem um guia aos fabricantes de dispositivos médicos e autoridades reguladoras para o desenvolvimento de dispositivos médicos inovadores como o BioMultiDress. Foi preparada uma versão preliminar do Dossier de Design do BioMultiDress, contendo os principais resultados deste trabalho.

Background: The premarket assessment of medical devices by an independent regulator is necessary to ensure that devices are safe and effective before they are made available to consumers in Australia. This responsibility is further necessitated by the practice of direct-to-consumer advertising (DtCA), whereby devices can be promoted to, and accessed by consumers without the involvement of a registered healthcare practitioner. An increase in the number of complaints against medical device advertising in Australia has raised questions around the effectiveness of the current regulations at ensuring that devices and their advertising material are adequately supported by evidence. Aims: The aim of this thesis is to explore the relationship between scientific evidence and DtCA in the policy context of medical device regulation in Australia. This aim is investigated using a case study of three emerging breast cancer imaging devices: digital infrared thermal imaging (DITI), electronic impedance scanning (EIS) and electronic palpation imaging (EPI). In this thesis, the evidence supporting the safety and effectiveness of these devices is evaluated, the nature and frequency of claims presented in online advertisements for these devices are assessed and compared against the available evidence, and stakeholders are engaged in a discussion around options to reform the regulation of medical devices and medical device advertising. Methods: A mixed methods approach was undertaken, involving three interrelated studies. The first study presents a systematic review of the available evidence for the safety and effectiveness of DITI, EIS and EPI. Following the systematic review, a quantitative content analysis was used to investigate the evidentiary basis of advertising claims made on websites that promote DITI, EIS and EPI in Australia. Finally, the results of the first two studies were used to inform stakeholder engagement around options to reform the regulation of medical devices and medical device advertising. Thematic analysis was used to synthesise stakeholder preferences in relation to a series of reform options proposed by Australia’s principal therapeutic goods regulator, the Therapeutic Goods Administration (TGA). Results: Study 1 As no direct effectiveness data were identified, the surrogate outcome measure of diagnostic accuracy became the primary focus of the systematic review. Significant heterogeneity was present among all three device classes, limiting the potential for meta-analyses. There was insufficient evidence to support the use of DITI, EIS or EPI for breast cancer screening, and the reported estimates of the sensitivity and specificity in symptomatic populations varied greatly for DITI (Sens 0.25-0.97, Spec 0.12-0.85) and EIS (Sens 0.26- 0.98, Spec 0.08-0.81), while only two poor quality studies were identified for EPI. Study 2 Thirty-nine Australian websites promoting DITI, EIS or EPI were identified. Despite a lack of primary evidence identified in the prior systematic review, the devices were advertised for diagnosis (n = 22 websites), screening (n = 20), prevention (n = 13) and risk factor identification for breast cancer (n = 13). Similarly, advertising claims of diagnostic accuracy (Sens 0.78-0.99, Spec 0.44-0.91) did not reflect the evidence base. Direct comparisons with conventional imaging were highly prominent (n = 31), and one third of websites explicitly promoted their device as a suitable alternative to conventional imaging (n = 12). Study 3 Sixteen stakeholders representing breast cancer research, patient advocacy and screening provided input into reforms to premarket medical device regulation and advertising proposed by the TGA. Participants highlighted important benefits and limitations of the proposed options. Differences between the TGA’s options for reform and stakeholder views indicated a need to update the current model for regulation that allows consumer choice and supports innovation, but within a more tightly regulated, safety-oriented framework. Conclusion: Online advertising claims made for DITI, EIS and EPI extend the indications and efficacy of these devices beyond the available research evidence. This disconnect suggests the regulatory framework tasked with ensuring the safety and efficacy of these devices and their promotion is in need of reform. Extending the current regulations for advertising preapproval to include medical devices, assessing diagnostic imaging devices for efficacy prior to market, and monitoring the use of a device in practice compared to its approved use on the Australian Register of Therapeutic Goods (ARTG) will help close the gap between DtCA and the evidence for emerging breast imaging devices.
Thesis (Ph.D.) -- University of Adelaide, School of Population Health, 2014

The demand for medical products is increasing. However, their manufacturing and application are subject to regulation and certification processes. The aim of this thesis is to discuss the development of this industry in the context of the new Medical Device Regulation (MDR). Expert interviews from production, medical law, the field of medicine, including the university environment, are qualitatively evaluated on the basis of the theoretical concept of the relationship between regulation and innovation. Agreements and controversies about the intentions of the MDR are captured and possible reactions to the changing European legislation are depicted.

RESUMO - A presente dissertação versa sobre análise política da implementação do Regulamento (UE) 2017/745 relativo aos dispositivos médicos em Portugal na ótica dos distribuidores. O Regulamento vem responder a falhas regulamentares do panorama europeu, que por sua vez conduziram a problemas de saúde pública. Prevê-se que o novo quadro normativo colmate as lacunas detetadas e contribua para a proteção da saúde dos europeus através da garantia da elevada qualidade e segurança dos dispositivos médicos comercializados no Espaço Económico Europeu. Uma forma, bastante usada, para avaliar políticas é através da análise da fase da implementação, porque é, no fundo, a passagem da teoria à prática. É a aplicação da política, neste caso do Regulamento, no terreno. Observando a sua implementação é possível averiguar se de facto o Regulamento contribuirá, como se propõe, a melhorar a saúde pública. O setor da distribuição de produtos de saúde é muito forte em Portugal pelo que se considerou pertinente trabalhar a ótica da Distribuição de Dispositivos Médicos, para entender de que forma é que vão levar a cabo a implementação do Regulamento, ou de que forma já o estão a implementar. Esta dissertação faz uma investigação do âmbito qualitativo, utilizando como técnicas de recolha de dados a análise documental e as entrevistas semi-estruturadas. Utiliza também revisão de literatura para enquadrar a situação e para estudar a análise de implementação. Deste trabalho podem retirar-se algumas conclusões: verifica-se que o processo de implementação usa abordagem mista entre top-down e bottom-up; os implementadores (distribuidores a trabalhar em território português) estão interessados em cumprir o Regulamento (compliance); existe envolvimento das partes interessadas na construção da política e ao longo do processo de implementação; existe algum desfasamento (misfit) da política europeia para a nacional (no espetro dos dispositivos médicos); notam-se como dificultadores da implementação fatores administrativos/institucionais; julga-se que o Regulamento alcançará os objetivos a que se propõe e a sua meta.
ABSTRACT - This study deals with the political analysis of the implementation of the Regulation (EU) 2017/745 on medical devices in Portugal from the perspective of distributors. The Regulation responds to regulatory failures in the European regulatory framework, which in turn led to public health issues. The new regulatory framework is expected to address the detected gaps and contribute to the protection of the health of Europeans by ensuring the high quality and safety of medical devices marketed in the European Economic Area. One widely used technique to evaluate policies is implementation analysis, because it is the link between theory and practice. It is the application of policy, in this case the Reg-ulation, on the field. By understanding the implementation, it is possible to ascertain whether, in fact, the Regulation will contribute, as proposed, to improving public health. The health products distribution sector is very strong in Portugal so it was considered pertinent to work on the Medical Device Distribution perspective in order to understand how they will implement the Regulation, or how they are already doing so. This qualitative study uses document analysis and semi-structured interviews to collect data. It also uses literature review to frame the situation and to study implementation analysis. Some conclusions can be drawn from this work: the implementation process uses a top-down and bottom-up mixed approach; implementers (distributors working in Portugal) are interested in complying with the Regulation; there is stakeholder involvement in pol-icy making and throughout the implementation process; there is some misfit between European and national policy (in the medical device sector); the administrative and insti-tutional factors are the main pain-points of the implementation; it is believed that the Regulation will achieve its intended objectives and goal.