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Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products

Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the... Current Directions in Biomedical Engineering 2019 ;5(1):609-612 Magdalena Kedwani*, Jörg Schröttner, Christian Baumgartner Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products Abstract: Due to globalization and the quick development of Keywords: Registration, medical product, harmonization, technology, each government aims to ensure the safety and global market placement, procedure performance of products brought to their markets to protect its population. The peoples’ health state is of great significance https://doi.org/10.1515/cdbme-2019-0153 and influenced easily by the quality of medical products. Therefore governments enact laws, directives and regulations to assure that quality. Nevertheless, these regulations can 1 Background impede innovation and create trade barriers which result in an adverse effect on national economies. Where in some states no At some point of the design and development phase addressing regulatory system is installed, others have highly sophisticated product registration is necessary for manufacturers. Already registration requirements that must be met. These diversities during the concept phase or latest during product development result in a challenge especially for small and medium sized this conformity with regulatory requirements is necessary, companies, whose resources are often limited. [1] with that a placement on the market is not delayed resulting in Manufacturers must control these diverse regulatory a financial damage for the company. [2] requirements by analyzing each market. Therefore an efficient The most important task is investigating different national procedure of registration should be defined that streamlines regulatory requirements and evaluating if market placement is different registration requirements and ensures regulatory possible. The investigation is challenged though since compliance. Next to regulatory authorities describing these information sources are often only available in national requirements also harmonization groups play an important role language or simply not to be found. Additionally if global in the design of the global regulatory landscape. Therefore also market placement should be achieved, the diversity of the the most important harmonization groups and their current regulatory requirements complicates product registration. activities were investigated. This is where harmonization groups have taken up the task The analysis showed that the impact of harmonization groups to equalize these diversities and to define consistent can be identified easily since new defined or updated registration requirements. By describing one set of documents, regulatory requirements are oriented on their guideline. Still which provides evidence for the safety and effectiveness of the the harmonization of regulatory requirements in the medical product, global market placement should be possible. To device sector is not sufficiently enhanced. Thus the achieve this goal these groups describe guidelines for confrontation with each national regulatory system is governments as well as manufacturers. By analysing these inevitable. guidelines, the impact on regulatory systems can be detected. Some countries have already managed the harmonization of the regulatory requirements, for instance the member states of the European Union or the member states of the Association of Southeast Asian Nations (ASEAN). Here, each country has ______ agreed on a regulatory framework describing requirements for *Corresponding author: Magdalena Kedwani: Institute of the market placement of medical products. But even those Health Care Engineering, Stremayergasse 16, TU Graz, Graz, countries have national variations that must be considered Austria, mkedwani@gmail.com Jörg Schröttner, Christian Baumgartner: Institute of Health preparing the technical dossier. Care Engineering, Stremayergasse 16, TU Graz, Graz, Austria, schroettner@tugraz.at, christian.baumgartner@tugraz.at Open Access. © 2019 Magdalena Kedwani et al., published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0 License. M. Kedwani et al., Analysis of regulatory requirements of medical devices and i-nvitro diagnostics worldwide — 610 For the market placement of medical products, it is 2.1 Africa essential for the manufacturer to identify each national In Africa there is a wide range of different and complex regulatory requirement and to design a proper strategy for the market placement. This can only be achieved with a proper economic states, political instabilities and social situations that analysis of regulatory systems as well as harmonization must be considered. activities. An efficient procedure of registration, which reacts Predominantly, the regulation of medical devices (MDs) on local requirements and displays them clearly, is inevitable and in-vitro devices (IVDs) in Africa is weakly defined. The to save valuable resources. access to medical products is limited due to their availability and costs. Additionally, trained personnel or laboratory facilities for the correct handling of some diagnostic tests are often missing. If a medical product is regulated or not, depends 2 Regulatory requirements on its intended purpose. If the product lies within the scope of worldwide curing, identifying or assisting the treatment of a specific infectious disease, such as tuberculosis, malaria or HIV/AIDS, There is a chasm between developing countries, which have the activities toward creating or strengthening regulations are hardly defined regulations for medical products yet, and the reinforced by the national regulatory authorities due to the industrial states, which prescribe demanding regulations for support of help organizations. [4] placing such products on their markets. It is the manufacturers task to analyze the different requirements and assure their fulfillment. Weak regulation of medical products represents a 2.2 North- and South America major risk for the population. By prescribing them, states perceive their protecting duty for its people, but at the same In North and South America, the regulatory landscape is time increases the costs for complying with these regulations diverse. In Northern America the Food and Drugs for manufacturers, which often pass on their costs to patients. Administration (FDA) as well as Health Canada, which are the Clear regulatory requirements for protection, including the regulatory authorities there, rule the market of medical possibility of their realistic implementation for manufacturers, products. The U.S.`FDA defines three different procedures should be the goal of each national legislation. [1] that can lead to market clearance in the United States of The most common way to achieve an efficient regulatory America dependent on the product group and a substantial system is the definition of a risk-based approach of regulatory equivalent product. [5] controls, in other words, a classification system. A band aid Health Canada has recently changed their requirements does not need the same regulatory controls as a hip prosthesis. for manufacturer to give prove to their Quality Management Thus, regulatory controls are contingent upon the level of risk System (QMS). In January 1st of 2019 the transition deadline associated with a medical product, where risk is a combination for the Medical Device Single Audit Program (MDSAP) of the probability of occurrence of any harm and severity of passed. This means that from now on, only MDSAP that harm. The result is a benefit for regulatory authorities, certifications for manufacturer`s QMS are valid for product manufacturers, users and patients, by focusing resources on registration. [6] high risk products, where a close control is indispensable. The South American Nations have also established strict Additionally, the reduction of effort for low risk products regulatory systems. Here often a registration holder, who is removes market barriers, enables high quality products for responsible for the communication with the regulatory patients and leaves space for innovation. [2, 3] authority and the registration is needed. Also, an evidence of a There are two classification options for the assignment of QMS is advised for launching in such markets. [5] products to the corresponding risk classes: either rule-based, or group-based. A rule-based classification system defines specific rules, which must be applied to identify the final risk 2.3 Asia classification. A group-based system defines product groups In Asia big markets like China, Japan and Russia define strict which are already assigned to a risk class. By the assignment regulations that must be complied with for national market to a product group the risk class can be determined. Another placement. Here, the language differences often complicate distinction can be made between a three and four-tire based the procedure. system, where a trending to four-tire based systems can be Smaller markets in South East Asia, which are members derived. of the Association of South East Asian Nations (ASEAN) have agreed on a medical device directive (AMDD), which consists M. Kedwani et al., Analysis of regulatory requirements of medical devices and i-nvitro diagnostics worldwide — 611 The total impact on the medical device sector in Europe of 24 articles, which describe inter alia, Essential Principles, remains to be seen, since manufacturers, notified bodies and Classification rules of medical devices and IVDs, conformity regulatory authorities are confronted with open questions and assessment procedures, and labeling requirements. The challenges regarding the requirements of the new regulations. process of implementing the directive in each national law is [10] though not completed yet. [7, 8] 2.5 Oceania 2.4 Europe The member states of the EU managed a harmonization of The regulatory systems in New Zealand and Australia are regulations for depleting trade barriers within their territory. stable with the Australian Therapeutic Goods Administration Three directives have ruled the regulatory landscape since the (TGA) and the MedSafe as their regulatory authorities. The 1990´s. The scopes of these directives are medical devices impact of the harmonization group Global Harmonization (93/42/EEC - MDD), active implantable medical devices Task Force (GHTF), which is now replaced by the (90/385/EEC - AIMD) and in-vitro diagnostic medical devices International Medical Device Regulators Forum (IMDRF), (98/79/EC - IVDD). For active implantable medical devices can be identified easily since the registration requirements are and medical devices complementary directives were published aligned with their principles and guidelines. [11] in 2007 to complete their regulatory requirements. [5] These directives will be definitely replaced in 2020 by the regulation for medical devices (2017/745-MDR) and in 2022 3 Harmonization of regulatory by the regulation for in-vitro diagnostic medical devices th (2017/745-IVDR), which became effective on May 25 2017. requirements Generally speaking, the difference between a directive and a regulation is, that a directive must be transformed into When regulatory authorities started describing requirements, national law by each member state of the EU, where a harmonization groups were formed trying to streamline these regulation is binding in its full extent. [9] different requirements. One of the most important Content-related the most obvious change is, that there are harmonization groups would be the already mentioned only two regulations left. This can be explained by the scope IMDRF. of the MDR, which now also includes active implantable It is a voluntary group which was founded in 2011 to medical devices. Next to the changes of the classification continue the work of the GHTF, founded in 1992. Current systems, there are updates regarding economic operators, the members of the IMDRF are Australia, Brazil, Canada, China, creation of an EU database called EUDAMED, an obligatory EU, Japan, Russia, Singapore, South Korea and the USA. Unique Device Identification (UDI), new requirements for Official observer is the WHO, which is not involved in the notified bodies, stricter requirements for clinical studies, decision-making procedure though. Also, there are Affiliate performance evaluations and post-market surveillance systems Organizations which may be invited for Management and more precise requirements for risk- and quality Committee meetings for observations, which are the Asia- management and the technical documentation. Also, in Pacific Economic Cooperation (APEC) LSIF Regulatory comparison to the directives, the assessment of a full QMS is demanded already for products which inherited lower risk. Harmonization Steering Committee, the AHWP the PAHWP. The new set of regulations EU was a necessary reactive The Committee of the IMDRF identifies specific activities in measure to scandals associated with medical products. The their work plan and establishes working groups. These directives left statutory gaps for faceless manufacturers to working groups develop technical documents and guidelines. place products on the European market. Nonetheless, one [12] major fear regarding the new regulations is a disadvantage for Another harmonization group worth mentioning would be small companies and innovation leading to the deceleration of the ASEAN which is generally an international organization medical progress, which has negative impacts on the patients aiming the improvement of the economic, political and social after all. Not only manufacturers are faced with challenges but collaboration of the member states. In the medical device also notified bodies, which play an important role in the sector it aims to harmonize the registration procedure of conformity assessment procedures. There is a lack of medical products in the area of Southeast Asia by establishing specialists that perform as auditors of notified bodies, but more a medical device directive (AMDD) effective for all member medical products will need their approval since many products countries, which are Brunei, Cambodia, Indonesia, Laos, will result in a higher risk class according to the regulation. M. Kedwani et al., Analysis of regulatory requirements of medical devices and i-nvitro diagnostics worldwide — 612 docs/ghtf-sg1-n15-2006-guidance-classification-060627.pdf. Malaysia, Myanmar, the Philippines, Singapore, Thailand and [Accessed 07 January 2019]. Vietnam. [7, 8] [5] S. P. Rugera, R. McNerney, A. K. Poon, G. Akimana, F. Mariki, H. Kajumbula, E. Kamau, S. Mpawenimana, S. Y. Said, A. Toroitich, W. Ronoh, K. A. Sollis, S. Sonoiya and R. W. Peeling. Regulaton of medical diagnostics and 4 Conclusion medical devices in the East African community partner states. 2014. The field of medical device market placement is constantly [6] P. Müllner and M. Guggenbichler. Rechtliches Umfeld und Zulassungsanforderungen. in Harer, J., Baumgartner C.: changing. Access to affordable high-quality medical products Anforderungen an Medizinprodukte - Praxiasleitfaden für is only possible by establishing regulatory authorities, which Hersteller und Zulieferer, München, Hanser, 2018, pp. 54- define smart regulations and perform pre- and post-market controls and registration requirements, which include a [7] C. Johner. MDSAP: Medical Device Single Audit Program. Johner Institute GmbH, 31 May 2018. [Online]. Available: realistic implementation of manufacturers. Manufacturers https://www.johner-institut.de/blog/regulatory- should therefore be supported by regulatory authorities during affairs/mdsap-medical-device-single-audit-program/. the registration procedure with guidelines as well as [Accessed 31 January 2019]. harmonization activities. [8] Qualtech Medical Device Regulation & CRO, .INDONESIA: Procedures of Classification of Medical Devices and In Manufacturer should describe a proper technical dossier, Vitro Diagnostics Device in Indonesia – June 2018. June where the technical dossier should at least include the 2018. [Online]. Available: requirements of harmonization groups. Additionally, a proper http://www.qualtech.com.tw/en/about- QMS is not only almost obliged for market placement but of qualtech/news1/1028-procedures-of-classification-of- course for the company itself. medical-devices-and-in-vitro-diagnostics-device-in- indonesia-june-2018.html. [Accessed 11 February 2019]. [9] S. Eisenhart. Whatever happened to the ASEAN Medical Author Statement Device Directive. Emergo, 26 April 2016. [Online]. Conflict of interest: The authors state no conflict of interest. Available: https://www.emergobyul.com/blog/2016/04/whatever- happened-asean-medical-device-directive. [Accessed 29 January 2019]. References [10] Euopäische Union. Verordnung, Richtlinien und sonstige Rechtsakten. 24 May 2018. [Online]. Available: [1] A. Kaushik, K. Saini, B. Anil and S. Rambabu. Harmonized https://europa.eu/european-union/eu-law/legal-acts_de. Medical Device Regulation: Need, Challanges, and Risks of [Accessed 22 January 2019]. not Harmonizing the Regulation in Asia. Journal of Young [11] M. Schmid , “Die neuen EU-Medizinprodukte- Pharmacists, no. 2, pp. 101-106, 2010 Verordnungen: Änderungen und offene Fragen,” 25 [2] C. De Maria, L. Di Pietro , A. Dìaz Lantada, J. Madete, P. September 2017. [Online]. Available: Ngaju Makabore, M. Mridha, A. Ravizza, J. Torop and A. https://www.encotec.at/2017/09/die-neuen-eu- Ahluwalia. Safe innovation: On medical device legislation in medizinprodukte-verordnungen-aenderungen-und-offene- Europe and Africa. Health Policy and Technology 7, pp. 156- fragen/. [Accessed 19 January 2019]. 165, 09 February 2018 [12] Emergo. Medical Device Registration in Australia and New [3] S. Lamph. Regulation of medical devices outside the Zealand. July 2017. [Online]. Available: European Union. Journal of the Royal Society of Medicine, https://www.emergobyul.com/resources/articles/white- pp. 12-21, 2012 paper-australia-new-zealand. [Accessed 29 January 2019]. [4] Global Harmonization Task Force (GHTF); International [13] International Medical Device Regulators Forum. About Medical Device Regulators Forum (IMDRF). Princinples of IMDRF. [Online]. Available: Medical Device Classification. 27 June 2006. [Online]. http://www.imdrf.org/about/about.asp. [Accessed 19 Available: http://www.imdrf.org/docs/ghtf/final/sg1/technical- November 2018]. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Current Directions in Biomedical Engineering de Gruyter

Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products

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Abstract

Current Directions in Biomedical Engineering 2019 ;5(1):609-612 Magdalena Kedwani*, Jörg Schröttner, Christian Baumgartner Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products Abstract: Due to globalization and the quick development of Keywords: Registration, medical product, harmonization, technology, each government aims to ensure the safety and global market placement, procedure performance of products brought to their markets to protect its population. The peoples’ health state is of great significance https://doi.org/10.1515/cdbme-2019-0153 and influenced easily by the quality of medical products. Therefore governments enact laws, directives and regulations to assure that quality. Nevertheless, these regulations can 1 Background impede innovation and create trade barriers which result in an adverse effect on national economies. Where in some states no At some point of the design and development phase addressing regulatory system is installed, others have highly sophisticated product registration is necessary for manufacturers. Already registration requirements that must be met. These diversities during the concept phase or latest during product development result in a challenge especially for small and medium sized this conformity with regulatory requirements is necessary, companies, whose resources are often limited. [1] with that a placement on the market is not delayed resulting in Manufacturers must control these diverse regulatory a financial damage for the company. [2] requirements by analyzing each market. Therefore an efficient The most important task is investigating different national procedure of registration should be defined that streamlines regulatory requirements and evaluating if market placement is different registration requirements and ensures regulatory possible. The investigation is challenged though since compliance. Next to regulatory authorities describing these information sources are often only available in national requirements also harmonization groups play an important role language or simply not to be found. Additionally if global in the design of the global regulatory landscape. Therefore also market placement should be achieved, the diversity of the the most important harmonization groups and their current regulatory requirements complicates product registration. activities were investigated. This is where harmonization groups have taken up the task The analysis showed that the impact of harmonization groups to equalize these diversities and to define consistent can be identified easily since new defined or updated registration requirements. By describing one set of documents, regulatory requirements are oriented on their guideline. Still which provides evidence for the safety and effectiveness of the the harmonization of regulatory requirements in the medical product, global market placement should be possible. To device sector is not sufficiently enhanced. Thus the achieve this goal these groups describe guidelines for confrontation with each national regulatory system is governments as well as manufacturers. By analysing these inevitable. guidelines, the impact on regulatory systems can be detected. Some countries have already managed the harmonization of the regulatory requirements, for instance the member states of the European Union or the member states of the Association of Southeast Asian Nations (ASEAN). Here, each country has ______ agreed on a regulatory framework describing requirements for *Corresponding author: Magdalena Kedwani: Institute of the market placement of medical products. But even those Health Care Engineering, Stremayergasse 16, TU Graz, Graz, countries have national variations that must be considered Austria, mkedwani@gmail.com Jörg Schröttner, Christian Baumgartner: Institute of Health preparing the technical dossier. Care Engineering, Stremayergasse 16, TU Graz, Graz, Austria, schroettner@tugraz.at, christian.baumgartner@tugraz.at Open Access. © 2019 Magdalena Kedwani et al., published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0 License. M. Kedwani et al., Analysis of regulatory requirements of medical devices and i-nvitro diagnostics worldwide — 610 For the market placement of medical products, it is 2.1 Africa essential for the manufacturer to identify each national In Africa there is a wide range of different and complex regulatory requirement and to design a proper strategy for the market placement. This can only be achieved with a proper economic states, political instabilities and social situations that analysis of regulatory systems as well as harmonization must be considered. activities. An efficient procedure of registration, which reacts Predominantly, the regulation of medical devices (MDs) on local requirements and displays them clearly, is inevitable and in-vitro devices (IVDs) in Africa is weakly defined. The to save valuable resources. access to medical products is limited due to their availability and costs. Additionally, trained personnel or laboratory facilities for the correct handling of some diagnostic tests are often missing. If a medical product is regulated or not, depends 2 Regulatory requirements on its intended purpose. If the product lies within the scope of worldwide curing, identifying or assisting the treatment of a specific infectious disease, such as tuberculosis, malaria or HIV/AIDS, There is a chasm between developing countries, which have the activities toward creating or strengthening regulations are hardly defined regulations for medical products yet, and the reinforced by the national regulatory authorities due to the industrial states, which prescribe demanding regulations for support of help organizations. [4] placing such products on their markets. It is the manufacturers task to analyze the different requirements and assure their fulfillment. Weak regulation of medical products represents a 2.2 North- and South America major risk for the population. By prescribing them, states perceive their protecting duty for its people, but at the same In North and South America, the regulatory landscape is time increases the costs for complying with these regulations diverse. In Northern America the Food and Drugs for manufacturers, which often pass on their costs to patients. Administration (FDA) as well as Health Canada, which are the Clear regulatory requirements for protection, including the regulatory authorities there, rule the market of medical possibility of their realistic implementation for manufacturers, products. The U.S.`FDA defines three different procedures should be the goal of each national legislation. [1] that can lead to market clearance in the United States of The most common way to achieve an efficient regulatory America dependent on the product group and a substantial system is the definition of a risk-based approach of regulatory equivalent product. [5] controls, in other words, a classification system. A band aid Health Canada has recently changed their requirements does not need the same regulatory controls as a hip prosthesis. for manufacturer to give prove to their Quality Management Thus, regulatory controls are contingent upon the level of risk System (QMS). In January 1st of 2019 the transition deadline associated with a medical product, where risk is a combination for the Medical Device Single Audit Program (MDSAP) of the probability of occurrence of any harm and severity of passed. This means that from now on, only MDSAP that harm. The result is a benefit for regulatory authorities, certifications for manufacturer`s QMS are valid for product manufacturers, users and patients, by focusing resources on registration. [6] high risk products, where a close control is indispensable. The South American Nations have also established strict Additionally, the reduction of effort for low risk products regulatory systems. Here often a registration holder, who is removes market barriers, enables high quality products for responsible for the communication with the regulatory patients and leaves space for innovation. [2, 3] authority and the registration is needed. Also, an evidence of a There are two classification options for the assignment of QMS is advised for launching in such markets. [5] products to the corresponding risk classes: either rule-based, or group-based. A rule-based classification system defines specific rules, which must be applied to identify the final risk 2.3 Asia classification. A group-based system defines product groups In Asia big markets like China, Japan and Russia define strict which are already assigned to a risk class. By the assignment regulations that must be complied with for national market to a product group the risk class can be determined. Another placement. Here, the language differences often complicate distinction can be made between a three and four-tire based the procedure. system, where a trending to four-tire based systems can be Smaller markets in South East Asia, which are members derived. of the Association of South East Asian Nations (ASEAN) have agreed on a medical device directive (AMDD), which consists M. Kedwani et al., Analysis of regulatory requirements of medical devices and i-nvitro diagnostics worldwide — 611 The total impact on the medical device sector in Europe of 24 articles, which describe inter alia, Essential Principles, remains to be seen, since manufacturers, notified bodies and Classification rules of medical devices and IVDs, conformity regulatory authorities are confronted with open questions and assessment procedures, and labeling requirements. The challenges regarding the requirements of the new regulations. process of implementing the directive in each national law is [10] though not completed yet. [7, 8] 2.5 Oceania 2.4 Europe The member states of the EU managed a harmonization of The regulatory systems in New Zealand and Australia are regulations for depleting trade barriers within their territory. stable with the Australian Therapeutic Goods Administration Three directives have ruled the regulatory landscape since the (TGA) and the MedSafe as their regulatory authorities. The 1990´s. The scopes of these directives are medical devices impact of the harmonization group Global Harmonization (93/42/EEC - MDD), active implantable medical devices Task Force (GHTF), which is now replaced by the (90/385/EEC - AIMD) and in-vitro diagnostic medical devices International Medical Device Regulators Forum (IMDRF), (98/79/EC - IVDD). For active implantable medical devices can be identified easily since the registration requirements are and medical devices complementary directives were published aligned with their principles and guidelines. [11] in 2007 to complete their regulatory requirements. [5] These directives will be definitely replaced in 2020 by the regulation for medical devices (2017/745-MDR) and in 2022 3 Harmonization of regulatory by the regulation for in-vitro diagnostic medical devices th (2017/745-IVDR), which became effective on May 25 2017. requirements Generally speaking, the difference between a directive and a regulation is, that a directive must be transformed into When regulatory authorities started describing requirements, national law by each member state of the EU, where a harmonization groups were formed trying to streamline these regulation is binding in its full extent. [9] different requirements. One of the most important Content-related the most obvious change is, that there are harmonization groups would be the already mentioned only two regulations left. This can be explained by the scope IMDRF. of the MDR, which now also includes active implantable It is a voluntary group which was founded in 2011 to medical devices. Next to the changes of the classification continue the work of the GHTF, founded in 1992. Current systems, there are updates regarding economic operators, the members of the IMDRF are Australia, Brazil, Canada, China, creation of an EU database called EUDAMED, an obligatory EU, Japan, Russia, Singapore, South Korea and the USA. Unique Device Identification (UDI), new requirements for Official observer is the WHO, which is not involved in the notified bodies, stricter requirements for clinical studies, decision-making procedure though. Also, there are Affiliate performance evaluations and post-market surveillance systems Organizations which may be invited for Management and more precise requirements for risk- and quality Committee meetings for observations, which are the Asia- management and the technical documentation. Also, in Pacific Economic Cooperation (APEC) LSIF Regulatory comparison to the directives, the assessment of a full QMS is demanded already for products which inherited lower risk. Harmonization Steering Committee, the AHWP the PAHWP. The new set of regulations EU was a necessary reactive The Committee of the IMDRF identifies specific activities in measure to scandals associated with medical products. The their work plan and establishes working groups. These directives left statutory gaps for faceless manufacturers to working groups develop technical documents and guidelines. place products on the European market. Nonetheless, one [12] major fear regarding the new regulations is a disadvantage for Another harmonization group worth mentioning would be small companies and innovation leading to the deceleration of the ASEAN which is generally an international organization medical progress, which has negative impacts on the patients aiming the improvement of the economic, political and social after all. Not only manufacturers are faced with challenges but collaboration of the member states. In the medical device also notified bodies, which play an important role in the sector it aims to harmonize the registration procedure of conformity assessment procedures. There is a lack of medical products in the area of Southeast Asia by establishing specialists that perform as auditors of notified bodies, but more a medical device directive (AMDD) effective for all member medical products will need their approval since many products countries, which are Brunei, Cambodia, Indonesia, Laos, will result in a higher risk class according to the regulation. M. Kedwani et al., Analysis of regulatory requirements of medical devices and i-nvitro diagnostics worldwide — 612 docs/ghtf-sg1-n15-2006-guidance-classification-060627.pdf. Malaysia, Myanmar, the Philippines, Singapore, Thailand and [Accessed 07 January 2019]. Vietnam. [7, 8] [5] S. P. Rugera, R. McNerney, A. K. Poon, G. Akimana, F. Mariki, H. Kajumbula, E. Kamau, S. Mpawenimana, S. Y. Said, A. Toroitich, W. Ronoh, K. A. Sollis, S. Sonoiya and R. W. Peeling. Regulaton of medical diagnostics and 4 Conclusion medical devices in the East African community partner states. 2014. The field of medical device market placement is constantly [6] P. Müllner and M. Guggenbichler. Rechtliches Umfeld und Zulassungsanforderungen. in Harer, J., Baumgartner C.: changing. Access to affordable high-quality medical products Anforderungen an Medizinprodukte - Praxiasleitfaden für is only possible by establishing regulatory authorities, which Hersteller und Zulieferer, München, Hanser, 2018, pp. 54- define smart regulations and perform pre- and post-market controls and registration requirements, which include a [7] C. Johner. MDSAP: Medical Device Single Audit Program. Johner Institute GmbH, 31 May 2018. [Online]. Available: realistic implementation of manufacturers. Manufacturers https://www.johner-institut.de/blog/regulatory- should therefore be supported by regulatory authorities during affairs/mdsap-medical-device-single-audit-program/. the registration procedure with guidelines as well as [Accessed 31 January 2019]. harmonization activities. [8] Qualtech Medical Device Regulation & CRO, .INDONESIA: Procedures of Classification of Medical Devices and In Manufacturer should describe a proper technical dossier, Vitro Diagnostics Device in Indonesia – June 2018. June where the technical dossier should at least include the 2018. [Online]. Available: requirements of harmonization groups. Additionally, a proper http://www.qualtech.com.tw/en/about- QMS is not only almost obliged for market placement but of qualtech/news1/1028-procedures-of-classification-of- course for the company itself. medical-devices-and-in-vitro-diagnostics-device-in- indonesia-june-2018.html. [Accessed 11 February 2019]. [9] S. Eisenhart. Whatever happened to the ASEAN Medical Author Statement Device Directive. Emergo, 26 April 2016. [Online]. Conflict of interest: The authors state no conflict of interest. Available: https://www.emergobyul.com/blog/2016/04/whatever- happened-asean-medical-device-directive. [Accessed 29 January 2019]. References [10] Euopäische Union. Verordnung, Richtlinien und sonstige Rechtsakten. 24 May 2018. [Online]. Available: [1] A. Kaushik, K. Saini, B. Anil and S. Rambabu. Harmonized https://europa.eu/european-union/eu-law/legal-acts_de. Medical Device Regulation: Need, Challanges, and Risks of [Accessed 22 January 2019]. not Harmonizing the Regulation in Asia. Journal of Young [11] M. Schmid , “Die neuen EU-Medizinprodukte- Pharmacists, no. 2, pp. 101-106, 2010 Verordnungen: Änderungen und offene Fragen,” 25 [2] C. De Maria, L. Di Pietro , A. Dìaz Lantada, J. Madete, P. September 2017. [Online]. Available: Ngaju Makabore, M. Mridha, A. Ravizza, J. Torop and A. https://www.encotec.at/2017/09/die-neuen-eu- Ahluwalia. Safe innovation: On medical device legislation in medizinprodukte-verordnungen-aenderungen-und-offene- Europe and Africa. Health Policy and Technology 7, pp. 156- fragen/. [Accessed 19 January 2019]. 165, 09 February 2018 [12] Emergo. Medical Device Registration in Australia and New [3] S. Lamph. Regulation of medical devices outside the Zealand. July 2017. [Online]. Available: European Union. Journal of the Royal Society of Medicine, https://www.emergobyul.com/resources/articles/white- pp. 12-21, 2012 paper-australia-new-zealand. [Accessed 29 January 2019]. [4] Global Harmonization Task Force (GHTF); International [13] International Medical Device Regulators Forum. About Medical Device Regulators Forum (IMDRF). Princinples of IMDRF. [Online]. Available: Medical Device Classification. 27 June 2006. [Online]. http://www.imdrf.org/about/about.asp. [Accessed 19 Available: http://www.imdrf.org/docs/ghtf/final/sg1/technical- November 2018].

Journal

Current Directions in Biomedical Engineering – de Gruyter

Published: Sep 1, 2019

Keywords: Registration; medical product; harmonization; global market placement; procedure

There are no references for this article.