Relevant bibliographies by topics / Regulation of medicines and medical devices

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  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Regulation of medicines and medical devices'

Author: Grafiati
Published: 12 December 2022
Last updated: 26 January 2023

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Journal articles on the topic "Regulation of medicines and medical devices"

1

Parvizi, Nassim, and Kent Woods. "Regulation of medicines and medical devices: contrasts and similarities." Clinical Medicine 14, no. 1 (February 2014): 6–12. http://dx.doi.org/10.7861/clinmedicine.14-1-6.

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Мурашко, Михаил, and Mihail Murashko. "2019: time for innovations (following the conference «FarmMed Appeal–2019»)." Vestnik Roszdravnadzora 2019, no. 3 (June 26, 2019): 5–20. http://dx.doi.org/10.35576/article_5d135f4a303e79.40852064.

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The article presents major directions of the modern regulation over circulation of medicines and medical devices including biomedical cellular products. Particular attention is focused on matters of the purchase of medicines and medical devices, the drug label and the maintenance of a safety of medical products.
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Ordeanu, Viorel, Lucia Ionescu, Victoria Dumitrescu, Roxana Pricop, Razvan Neagu, and Diana Popescu. "Medical devices in current medicine." Romanian Journal of Military Medicine 123, no. 4 (November 1, 2020): 253–57. http://dx.doi.org/10.55453/rjmm.2020.123.4.3.

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The treatment of diseases is based on pharmacological and non-pharmacological means, but adequate devices are needed for their application. Medicine uses a wide range of medical devices. Currently, many medical devices are used, many of them being disposable. As recognition of the importance of medical devices, the national authority of the drug is the ANMDM (National Agency for Medicines and Medical Devices). Medical devices are indispensable for therapy, and their evolution has led to an extraordinary diversification of the field and the emergence of industry related to the pharmaceutical industry, with specific laws and regulations.
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Chejor, Pelden, Jigme Tenzin, and Jigme Dorji. "Regulation of Medicines in Bhutan: Current Status, Challenges and Opportunities." International Journal of Drug Regulatory Affairs 6, no. 2 (June 15, 2018): 54–58. http://dx.doi.org/10.22270/ijdra.v6i2.243.

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Medicines Regulatory Agencies (MRAs) are responsible for evaluation of quality, safety and efficacy of medicinal products before it is approved for consumption. The regulatory procedures, however, differs from one country to another. Medical products including vaccines, blood and blood products, diagnostics and medical devices are essential for healthcare delivery across the world. The Drug Regulatory Authority (DRA) is an independent national agency for regulation of medicinal products in Bhutan and reports to Bhutan Medicines Board (BMB), the highest policy making body for regulation of medicinal products in the country. Medicines Act of the Kingdom of Bhutan is the legal tool for regulation of medicines in Bhutan. Medicinal products are regulated through premarketing and post-marketing control systems. All medicinal products available in the Bhutanese market are registered. DRA regulates all the medicinal products including vaccines, blood products and traditional medicines used for human and veterinary. DRA is fully financed by the Government of Bhutan. Bhutan’s medicines regulatory system has evolved over the last one decade. However, as the regulatory mandate continues to increase, DRA is faced with several challenges in terms of human resource, infrastructure and testing laboratory among others. There are also opportunities for the DRA to improve its regulatory capacities to ensure availability of quality and safe medicines for the public. Understanding the current practice of medicines regulation in Bhutan can help identify gaps and existing opportunities for improving the regulatory capacity. This article documents the existing practices, challenges and opportunities for regulation of medicinal products in Bhutan.
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Altenstetter, Christa. "EU AND MEMBER STATE MEDICAL DEVICES REGULATION." International Journal of Technology Assessment in Health Care 19, no. 1 (January 2003): 228–48. http://dx.doi.org/10.1017/s0266462303000217.

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This article examines European Union (EU) and member state regulation of medical devices, particularly: a) the similarities and differences between medical devices and prescription drugs, including the respective industries, market authorization pathways, and boundary issues between the two sectors; b) the political background, current nature, and future prospects for EU medical device regulation; and c) regulatory responsibilities of the member states. Included are definitions of medical devices and in vitro diagnostics, and a brief history of their treatment by European law. The erosion of boundaries between exclusive and shared responsibilities of the EU and member states will be addressed, especially as it affects market approval of medical devices, clinical investigations, labeling and instructions for use, price setting and reimbursement, and evidence-based medicine and healthcare technology assessment. Finally, the article discusses medical device reporting and surveillance systems, which may be the weakest link in the EU integrative process. If patient safety is as important to the EU regulatory scheme as free movement and competitiveness, then both Brussels and member states will require additional resources, as well as measures to overcome obstacles to implementation, evaluation, and accountability.
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Lesmana, Giannina Meracellene, Matthew Darrell Tenando, and Vienda Mustika Dewi. "Pharmaceutical and Medical Devices Industry Regulation in Indonesia: Human Rights Perspective." Jurist-Diction 5, no. 2 (March 31, 2022): 521–36. http://dx.doi.org/10.20473/jd.v5i2.34892.

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AbstractA deficiency in supply of medicines and medical devices, especially in remote areas, has become a national problem since the mid-2000s until now. This problem is certainly made worse by the presence of COVID-19. The main causes of this supply shortages are, among others, economic factors, ineffective regulations that result in problems related to business and supply chains. Indonesia, a country where 90% of raw materials for medicines are imported from abroad, of course is deeply affected by the export ban of countries that supply raw materials. Do not forget that Indonesia's geographical condition is so vast that it creates huge obstacles for the distribution of drugs and medical devices, and it is understandable if the private sector does not want to open hospitals, pharmacies or clinics in remote areas due to economic factors. As a result, human health, something which should be a human right feels like a luxury during this pandemic. Therefore several policies have been implemented, ranging from increasing production capacity, enacting regulations regarding limits on the number of drugs that can be prescribed to patients or purchased by the public to prevent hoarding, simplifying the industrial licensing process to increasing hospital beds.Keywords: Medical Devices; Medicine; COVID-19. AbstrakKurangnya pasokan obat dan alat kesehatan khususnya di daerah terpencil telah menjadi masalah nasional sejak pertengahan tahun 2000-an hingga saat ini. Masalah ini tentunya diperburuk oleh adanya COVID-19. Penyebab utama kekurangan pasokan ini diantara lain karena faktor ekonomi, regulasi yang kurang efektif yang mengakibatkan masalah terkait bisnis dan juga rantai pasok. Indonesia sebuah negara dimana 90% bahan baku obat obatan didatangkan dari luar negeri tentu sangat terpengaruh oleh larangan ekspor negara negara pemasok bahan baku. Tidak lupa kondisi geografis Indonesia yang begitu luas menghasilkan kendala yang begitu besar untuk distribusi obat dan alat medis, dan dapat dipahami jika pihak swasta tidak ingin membuka rumah sakit, apotek ataupun klinik di daerah terpencil karena faktor ekonomis. Lantas kesehatan yang seharusnya adalah Hak Asasi Manusia terasa seperti kemewahan di pandemi ini. Oleh sebab itu beberapa kebijakan yang dilakukan yaitu mulai dari meningkatkan kapasitas produksi, memberlakukan peraturan mengenai batasan jumlah obat yang dapat diresepkan untuk pasien atau dibeli oleh masyarakat untuk mencegah penimbunan, simplifikasi proses perizinan industri hingga memperbanyak tempat tidur rumah sakit.Kata Kunci: Alat kesehatan; Farmasi; COVID-19.
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Green, James IJ. "The impact of medical device regulation on hospital doctors who prescribe and manufacture custom-made devices." British Journal of Hospital Medicine 81, no. 12 (December 2, 2020): 1–6. http://dx.doi.org/10.12968/hmed.2020.0596.

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The 1990s saw the implementation of three European directives that aimed to standardise medical device legislation. EU regulations replace and repeal these directives, to improve the safety, effectiveness and traceability of medical devices. This article discusses the implications of the Regulation (EU) 2017/745 (Medical Device Regulation) for hospital doctors who prescribe and manufacture custom-made medical devices.
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Antich Isern, Pau, and Juan Aparicio Blanco. "The borderline with medical devices in the current Spanish legal framework." Anales de la Real Academia Nacional de Farmacia 88, no. 88(02) (June 30, 2022): 209–34. http://dx.doi.org/10.53519/analesranf.2022.88.02.06.

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Medical devices cover a wide range of products essential for healthcare. In 2017 a new European regulation covering them was approved that fully applies from 2021 onwards. In it, their legal definition, classification, conformity assessment procedures, requirements for the clinical investigations that asses their safety and/or performance, and European database are specified. Despite the efforts for systematizing the legal definition of medical device in the new regulation, the determination of the legal status of devices known as ‘borderline products’, for which different regulations may apply (like in the borderline with food supplements, cosmetics, personal care products, biocides, personal protective equipment and consumer products), is not without difficulties. On account of their therapeutic significance, this review delves into the borderline between medicinal products and medical devices, and differentiates them from presentations where medicinal products and medical devices are used in combination, without constituting a borderline. Establishing updated definitions, promoting transparency in the sector and preventing conflicts of interest should motivate all stakeholders to the periodic review of the regulation in a field in continuous technological evolution and development.
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Філінюк, О. М., Д. В. Алешко, М. М. Бабенко, К. Л. Косяченко, and Р. Кахвечі. "Decision-making regulatory framework of the introduction of health technologies at the hospitals in Ukraine." Farmatsevtychnyi zhurnal, no. 1 (February 23, 2022): 6–14. http://dx.doi.org/10.32352/0367-3057.1.22.01.

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The limited resources of the health care system and the COVID-19 pandemic encourage more rational and cost-effective administrative and clinical decisions. To achieve the best health care within available resources, the introduction of the most efficient technologies should be supported, considering organizational, social and ethical issues. Assessment of health technologies at different levels, namely national/regional and hospital, is becoming increasingly important. Adherence to cost-effective approaches to administrative and clinical decision-making will ensure the rational use of the state budget and improve clinical outcomes, improve the quality and life expectancy of patients. The purpose of the study was to analyze the current regulatory framework for the introduction of health technologies (medicines and medical devices) at the hospital level. During the research the methods of content analysis, historical, system-analytical, generalization was used. According to the analysis of the decision-making regulatory framework for the health technology’s introduction, it was drawn the next conclusions. The active HTA development in Ukraine is noted. In a short time, a legal framework for state HTA for medicines was created and approved, amendments were made to the Law of Ukraine ‘On Public Procurement’ and other Ukraine’s laws on medicine procurement under managed entry agreements, the further steps for development of the HTA ecosystem in Ukraine were identified. The legal framework for the circulation of medical devices needs to be updated in Ukraine, starting with technical regulations in accordance with EU regulations №745 and №746 and further approval of the Law on Medical Devices. Procedures for evaluation and selection of medicines and medical devices at the level of medical institutions are absent in Ukraine and require separate elaboration. The introduction of HB-HTA will help hospital managers to make independent, transparent, reasonable, and impartial management decisions on the selection of drugs and medical devices. The obtained results prove the need for further research of everyday decision-making practices on the introduction of health technologies at the hospitals, development of methodology for hospital-based HTA and update regulation of HB-HTA in the current legal framework of Ukraine.
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Chakaldziyan, Mikael. "THE NORMATIVE REGULATION OF MEDICAL DEVICES – A GUARANTOR FOR THE PROTECTION OF PATIENTS’ RIGHTS AS USERS OF HEALTH SERVICES IN THE REPUBLIC OF BULGARIA." Knowledge International Journal 34, no. 5 (October 4, 2019): 1567–72. http://dx.doi.org/10.35120/kij34051567c.

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Health is envisaged as a right of the citizens both in the Constitution of the Republic of Bulgaria and in the Treaty on the Functioning of the European Union. Healthcare is subject to regulation by a number of secondary European legislation acts as well as by acts of our domestic legislation. The overall state policy on health care provision and development constitutes a complex set of diverse activities. Its quality is largely the result of strict and good-faith implementation of the normative regulations, addressing both public authorities and individuals. Exercising preventive medical procedures, adequate diagnosis and conducting successful treatment are undoubtedly essential parts of healthcare. This essential part is implemented by healthcare professionals with specific qualifications and by using medicinal products that contribute to achieving positive results in each patient's health in every individual case. In turn, medical equipment such as apparatus, instruments, materials and other supplies, plays an increasingly important and crucial role in the overall process of the actual implementation of medical assistance. Today, secondary European legislation determines medical equipment as a medical device and defines it. The continued development of science in the field of medicine, as well as in other fields, is an important factor in achieving ever greater opportunities for medical care and determines the significant place of medical devices in the provision of healthcare to a particular patient. Using them is often the only way to correctly diagnose a patient, though the cases where the medicinal product itself comes into contact with the patient's body through a medical device are also not isolated. The presence of the appropriate type of medical device and its corresponding level of quality are essential prerequisites for proper diagnosis and conducting a precise treatment procedure to achieve the optimal end effect. To ensure a positive result in the patient's health, medical devices must be safe and meet a number of quality requirements. The safety and quality of medical devices are a prerequisite for the actual realization of the right to healthcare for citizens. This report examines some administrative-juridical remedies for exercising control over medical devices, as well as certain obligations that individuals should carry out when performing activities related to medical devices. Bearing in mind the actual object of protection in medical law - the patient, and that one of the principles of consumer law is to protect the life and health of the consumer as an individual, it is concluded that medical and consumer law have the same object of protection and that is every individual. The report makes a comparative analysis of the administrative-juridical measures taken by the Medicines Executive Agency and by the Consumer Protection Commission. It also compares some of the obligations that private law entities need to observe in medical law in respect to medical devices and those of private parties in consumer law regarding goods.
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Dissertations / Theses on the topic "Regulation of medicines and medical devices"

1

Brolin, Sandra. "Global Regulatory Requirements for Medical Devices." Thesis, Mälardalen University, School of Sustainable Development of Society and Technology, 2008. http://urn.kb.se/resolve?urn=urn:nbn:se:mdh:diva-700.

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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.

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Остап'юк, Марія Василівна, Мария Васильевна Остапьюк, and Mariia V. Ostapyuk. "Господарсько-правове регулювання державних закупівель лікарських засобів та медичних виробів." Thesis, Одеса, 2015. http://hdl.handle.net/11300/2340.

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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.
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Higson, Gordon R. "The regulation of medical devices for public health and safety." Thesis, University of Aberdeen, 2000. http://digitool.abdn.ac.uk/R?func=search-advanced-go&find_code1=WSN&request1=AAIU123856.

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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.
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Vavrečka, Jan. "Vzájemné rozlišování kategorií výrobků se zdravotními účinky v právním řádu EU." Doctoral thesis, Vysoká škola ekonomická v Praze, 2008. http://www.nusl.cz/ntk/nusl-165933.

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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.
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Germundsson, Frida, and Nicole Kvist. "MDR 2017/745 - New EU Regulation for Medical Devices: A Process Description for EHR Manufacturers on How to Fulfill the Regulation." Thesis, KTH, Medicinteknik och hälsosystem, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-279137.

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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.
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Qi, Jianing, and Shilun Wei. "The Impact of Medical Devices Regulations on Notified Bodies and Additive Manufacturing." Thesis, Uppsala universitet, Institutionen för samhällsbyggnad och industriell teknik, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-414216.

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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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Nascimento, Danielle de Oliveira Lima. "Levantamento diagnóstico para otimização da nanoregulação nacional de produtos para saúde." Universidade Estadual da Paraíba, 2017. http://tede.bc.uepb.edu.br/jspui/handle/tede/3073.

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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.
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Faustino, Tatiana Ribeiro. "Relatório de estágio na Direcção de Produtos de Saúde." Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/16508.

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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.
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Litavský, Ondřej. "Regulace uvádění zdravotnických prostředků na trh." Master's thesis, Vysoká škola ekonomická v Praze, 2015. http://www.nusl.cz/ntk/nusl-203825.

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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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Souza, Mara Clécia Dantas. "Regulação sanitária de produtos para a saúde no Brasil e no Reino Unido: o caso dos equipamentos eletromédicos." Programa de pós-graduação em saúde coletiva, 2007. http://www.repositorio.ufba.br/ri/handle/ri/10412.

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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.
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Books on the topic "Regulation of medicines and medical devices"

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Ensuring safe medicines and medical devices for children: Hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining ensuring safe medicines and medical devices for children, March 27, 2007. Washington: U.S. G.P.O., 2008.

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Professor, O'Grady John, ed. Medicines, medical devices, and the law. London: Greenwich Medical Media, 1999.

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FDA regulation of medical devices. Buffalo Grove, IL: Interpharm Press, 1995.

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Harman, Robin J. Development and control of medicines and medical devices. London: Pharmaceutical press, 2004.

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United, States Congress House Committee on Small Business Subcommittee on Regulation Business Opportunities and Technology. Problems in securing informed consent of subjects in experimental trials of unapproved drugs and devices: Hearing before the Subcommittee on Regulation, Business Opportunities, and Technology of the Committee on Small Business, House of Representatives, One Hundred Third Congress, second session, Washington, DC, May 23, 1994. Washington: U.S. G.P.O., 1994.

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United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology. Problems in securing informed consent of subjects in experimental trials of unapproved drugs and devices: Hearing before the Subcommittee on Regulation, Business Opportunities, and Technology of the Committee on Small Business, House of Representatives, One Hundred Third Congress, second session, Washington, DC, May 23, 1994. Washington: U.S. G.P.O., 1994.

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1948-, Gore Albert, and National Performance Review (U.S.), eds. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

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Clinton, Bill. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

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Clinton, Bill. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

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Clinton, Bill. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

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Book chapters on the topic "Regulation of medicines and medical devices"

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Mason, Shuna. "European Regulation of Medical Devices." In The Textbook of Pharmaceutical Medicine, 418–34. Oxford, UK: Blackwell Publishing Ltd., 2013. http://dx.doi.org/10.1002/9781118532331.ch21.

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Szalados, James E. "Statutory Controls and Regulation of Pharmaceuticals and Medical Devices." In The Medical-Legal Aspects of Acute Care Medicine, 547–71. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-68570-6_27.

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Chowdhury, Nupur. "Conceptualizing Multilevel Regulation." In European Regulation of Medical Devices and Pharmaceuticals, 25–46. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-04594-8_2.

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Baber, Nigel. "Career Opportunities in Medicines Regulation-The Medical Assessor." In Careers with the Pharmaceutical Industry, 247–54. Chichester, UK: John Wiley & Sons, Ltd, 2005. http://dx.doi.org/10.1002/0470013729.ch21.

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Chowdhury, Nupur. "Case Study on Pharmaceutical Regulation in Europe." In European Regulation of Medical Devices and Pharmaceuticals, 121–39. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-04594-8_7.

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Chowdhury, Nupur. "Case Study on Medical Devices Regulation in Europe." In European Regulation of Medical Devices and Pharmaceuticals, 99–119. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-04594-8_6.

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Almpani, Sofia, Petros Stefaneas, Harold Boley, Theodoros Mitsikas, and Panayiotis Frangos. "Computational Regulation of Medical Devices in PSOA RuleML." In Rules and Reasoning, 203–10. Cham: Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-319-99906-7_13.

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Chowdhury, Nupur. "Case Study on Borderline Medical Products in Europe." In European Regulation of Medical Devices and Pharmaceuticals, 141–59. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-04594-8_8.

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De Maria, Carmelo, Andrés Díaz Lantada, Licia Di Pietro, Alice Ravizza, and Arti Ahluwalia. "Towards a Harmonized Methodology for the Development of Safe and Regulation Compliant Open-Source Medical Devices." In Engineering Open-Source Medical Devices, 21–38. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-79363-0_2.

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Chowdhury, Nupur. "Introduction." In European Regulation of Medical Devices and Pharmaceuticals, 1–23. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-04594-8_1.

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Conference papers on the topic "Regulation of medicines and medical devices"

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Hojnik, Janja. "Challenges of the 4th Industrial Revolution for Medical Devices' Regulation in the EU." In 26th Conference Medicine, Law & Society. University of Maribor Press, 2017. http://dx.doi.org/10.18690/978-961-286-021-9.5.

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Zema, M., S. Rosati, V. Gioia, M. Knaflitz, and G. Balestra. "Developing medical device software in compliance with regulations." In 2015 37th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE, 2015. http://dx.doi.org/10.1109/embc.2015.7318614.

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Cayeux, S., A. Durand, M. Moreau, C. Vantyghem, and M. Belhout. "2SPD-020 Expired medicines and medical devices, an acrobatic management." In 24th EAHP Congress, 27th–29th March 2019, Barcelona, Spain. British Medical Journal Publishing Group, 2019. http://dx.doi.org/10.1136/ejhpharm-2019-eahpconf.60.

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Roberts. "Standards And Regulations For Medical Equipment And Devices - A European Perspective." In Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE, 1992. http://dx.doi.org/10.1109/iembs.1992.593822.

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Sezdi, Mana. "New Regulations on Quality Compliance and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices." In 2022 Medical Technologies Congress (TIPTEKNO). IEEE, 2022. http://dx.doi.org/10.1109/tiptekno56568.2022.9960185.

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Roberts, Colin. "Standards and regulations for medical equipment and devices — A European perspective." In 1992 14th Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE, 1992. http://dx.doi.org/10.1109/iembs.1992.5761719.

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Remirez, D. "Short Lecture “Regulatory considerations of herbal medicines. New focus for authorization as medical devices”." In GA – 70th Annual Meeting 2022. Georg Thieme Verlag KG, 2022. http://dx.doi.org/10.1055/s-0042-1758931.

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O’Clock, George D., Bruce H. KenKnight, and Elena G. Tolkacheva. "Vagus Nerve Stimulation for Blood Pressure and Heart Rate Regulation." In 2018 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/dmd2018-6847.

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For more than 27 years, implanted vagus nerve stimulation (VNS) devices, with electric current outputs in the 1 to 3.5 mA range, have been developed for many health care applications, including epilepsy and heart disease [1]. Mechanical compression approaches for VNS were administered under surgical conditions, using forceps, in the 1800’s [2]. Outcomes such as Electrocardiogram (ECG) data, blood pressure (BP), and heart rate (HR) were evaluated. Also, non-invasive (NI) mechanical compression of the vagus nerve for various nervous system disorders using hand, thumb, finger and belt pressure was popular in the 1800’s [3]. Cyberonics (now LivaNova) received the first FDA clearance for a surgically implanted electrical VNS device to treat refractory epilepsy in 1997.
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Lissel, A., F. Ottenberg, B. R. Bracio, A. Ravizza, C. De Maria, A. Ahluwalia, L. Di Pietro, and P. Trommler. "Status and solutions to medical device regulations for improving the healthcare landscape in Africa." In 2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE, 2016. http://dx.doi.org/10.1109/embc.2016.7591685.

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Singal, Ashish. "Design of Electromagnetic Coils and Temperature Regulation Circuits for Impeding Microbial Growth on Medical Device Surfaces." In 2017 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/dmd2017-3303.

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Microorganisms that form biofilm on surface of medical devices represent a major health risk for patients and an economic burden for the health care system [1]. Biofilms are conglomerates of bacterial colonies characterized by the production of an exo-polysaccharide matrix making it challenging to eradicate them by using chemical or antibiotic treatments [2]. More than 70% of biofilm-related infections are resistant to at least one drug, therefore, alternative forms of treatments have been investigated. Previously we have reported compelling new data showing the synergistic effects of electromagnetic fields (EMF) and elevated temperatures on the colonization and survival of pathogenic bacteria on medical device surfaces [3]. Here we report the design and development of prototypical EMF coils and temperature regulation circuits that are simple and cost effective for impeding microbial growth on medical device surfaces.
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Reports on the topic "Regulation of medicines and medical devices"

1

Budhavaram, Naresh, Vijay Damodaran, Damien Cavez, Sabrine Derkaoua, Nayla Francis, Angeline Renou, Jean-Michel Soro, et al. Implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements: a position paper. BioPhorum, January 2022. http://dx.doi.org/10.46220/2022mt001.

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Patient involvement in the development, regulation and safe use of medicines. Council for International Organizations of Medical Sciences (CIOMS), 2022. http://dx.doi.org/10.56759/iiew8982.

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This report from the Council for International Organizations of Medical Sciences (CIOMS) describes the importance of systematically involving patients throughout a medicine’s life – from its early development, through regulatory process to ongoing monitoring and safe use in everyday healthcare. It provides a comprehensive overview of the current knowledge about the benefits of patient involvement and existing initiatives, gives many examples and recommendations, and addresses the remaining challenges and practice gaps. The report will prompt readers to implement its best practice recommendations according to how well they fit in with their organisational and national needs. The report combines the experience and expertise of the CIOMS Working Group XI on Patient involvement in the development, regulation and safe use of medicines. It also incorporates views gathered from an open meeting in Switzerland and a workshop in Uganda, which both brought together members of the public, patient organisation representatives, regulators, drug development experts, industry, academia, health professionals and other related stakeholders. The report was finalised following a public consultation.
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CIOMS Cumulative Glossary, with a focus on pharmacovigilance. Council for International Organizations of Medical Sciences (CIOMS), September 2022. http://dx.doi.org/10.56759/ocef1297.

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Since its inception, CIOMS has published numerous reports on pharmaco¬vigilance and related fields, and this CIOMS Cumulative Pharmacovigilance Glossary compiles all the definitions within these reports. Version 1.1 newly includes the terms and definitions from the report of CIOMS Working Group XI on Patient involvement in the development, regulation and safe use of medicines. Reflecting the fact that recent CIOMS Working Groups have been dealing with topics that extend beyond pharmacovigilance, the title of Version 2.0 has been adapted to read ‘CIOMS Cumulative glossary, with a focus on pharmacovigilance terms’. The CIOMS Glossary does not cover CIOMS reports on the subjects of ethics, clinical pharmacology, product development, the Medical Dictionary for Regulatory Activities (MedDRA), or publications resulting from CIOMS Roundtable Discussions.
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Evidence Synthesis and Meta-Analysis for Drug Safety. Council for International Organizations of Medical Sciences (CIOMS), 2016. http://dx.doi.org/10.56759/lela7055.

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At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development programme and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. -- There is increasing demand by decision-makers in health care, the biopharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy will take an overview of all the evidence and where it is possible and sensible, combine the evidence and summarize the results. For efficacy, the outcomes generally use the same or very similar predefined events for each of the trials to be included. Most regulatory guidance and many Cochrane Collaboration reviews have usually given more attention to assessment of benefits, while issues around combining evidence on harms have not been as well-covered. However, the (inevitably) unplanned nature of the data on safety makes the process more difficult. -- Combining evidence on adverse events (AEs), where these were not the focus of the original studies, is more challenging than combining evidence on pre-specified benefits. This focus on AEs represents the main contribution of the current CIOMS X report. The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. -- Although some of the content of this report describes highly technical statistical concepts and methods (in particular Chapter 4), the ambition of the working group has been to make it comprehensible to non-statisticians for its use in clinical epidemiology and regulatory science. To that end, Chapters 3 and 4, which contain the main technical statistical aspects of the appropriate design, analysis and reporting of a meta-analysis of safety data are followed by Chapter 5 with a thought process for evaluating the findings of a meta-analysis and how to communicate these.
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