QMS for Medical Devices

Home/ Services/ Consulting/ QMS for Medical Devices ConsultingQMS for Medical Devices Support for New Entry into the Medical Device Industry The global market size for medical devices is estimated to be approximately 30 trillion yen, with around 2.8 trillion yen in Japan alone. This market is large and attractive for new entrants; however, medical devices are subject to stringent regulations under the “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices” (abbreviated as the Pharmaceuticals and Medical Devices Act or PMD Act). Even if a material or technology can be applied to medicine, there are significant hurdles to overcome in order to introduce it as a medical device to the market. CM Plus supports new entries by building a quality management system (QMS) based on the QMS Ordinance (ISO 13485) and conducting product design and development in accordance with the QMS from the early planning stages of medical devices, ensuring a smooth and irreversible entry into the market. Roadmap from Development to Market Launch of Medical Devices   “Medical Device Development Support Handbook” Revised in October 2023 From the Cabinet Secretariat (Healthcare and Medical Strategy Office), Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare, and Ministry of Economy, Trade and Industry ※indicates the scope of CM Plus’s medical device consulting services. Examples of Progression Steps within Japan STEP01 Acquisition of medical devices Marketing License and Registration of Manufacturing Business The manufacturing and marketing of medical devices in Japan must comply with the Pharmaceuticals and Medical Devices Act (PMD Act). To conduct manufacturing and marketing, it is necessary to obtain a medical devices marketing license, and to conduct manufacturing, it is required to register as a manufacturing business. STEP02 Establishment of QMS (Quality Management System) In order to carry out...

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Regenerative Medicine Consulting

Home/ Services/ Consulting/ Regenerative Medicine Consulting ConsultingRegenerative Medicine Consulting What is a regenerative medicine products?Classification under the Pharmaceutical and Medical Device Act A regenerative medicine product uses cells or genes for the treatment or prevention of diseases or injuries. The scope of regenerative medicine products defined under the Pharmaceutical and Medical Device Act (commonly known as the PMD Act) is as follows: 1.Products in which cells from humans or animals have been cultured or otherwise processed, with the purposes of:a. Reconstruction, repair, or formation of the structure or function of the body of humans or animals.b. Treatment or prevention of diseases in humans or animals. 2.Products intended for the treatment of diseases in humans or animals that involve the introduction of genes into human or animal cells to express them in the body. regenerative medicine products are classified separately from drugs and medical devices under the Pharmaceutical and Medical Device Act (commonly known as the PMD Act). Since regenerative medicine products involve the use of live cells or viruses themselves as products, specialized manufacturing and quality control different from those for drugs and medical devices are required. Difference Between “Products” and “Medical Care” in Regenerative Medicine In regenerative medicine, the applicable regulations differ depending on whether regenerative medicine products are provided by companies or medical care is offered within medical institutions. The former must comply with the Pharmaceutical and Medical Device Act (PMD Act) and adhere to the Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP) ordinance, requiring appropriate manufacturing facilities and stringent manufacturing and quality control. On the other hand, the latter is subject to theAct on Securing Safety of Regenerative Medicine, under which clinical research or private medical practice must be conducted.   CM Plus’s Support for Regenerative Medicine Products Steps from Development to Manufacturing and Sales...

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Education/Training Support

Home/ Services/ Education/Training Support ServicesEducation/Training Support We provide education that encourages thinking “why,” not just acquiring knowledge. In the manufacturing and sale of pharmaceuticals and other products, it is essential to comply with various regulations, starting with the Pharmaceutical and Medical Device Act. Moreover, as these products directly affect human and animal lives and health, there is a social mission and responsibility to maintain proper quality while ensuring a stable supply. Therefore, it is required for companies to plan and implement education and training programs for all employees that include mandatory GMP training, compliance, morality, and the ability to think and make judgments. Our education and training support services based on the “GMP Platform,” provide educational content focused on quality (manufacturing). Additionally, we offer education and training support programs that bring together various information and the expertise of our experienced consultants. Through those services, CM Plus assist in solving our clients' issues from the perspectives of both the quality system and the education system. Features of CM Plus Education/Training Support Aggregate of "knowledge", which keeps sharing the latest information On "GMP Platform" (https://www.gmp-platform.com/en/), CM Plus's web service, you can read the latest information and regulations in life science industries, and serial articles. GMP Platform By registering for a free membership, you will be able to access the published information. You can gather information from a series of articles and news topics related to GMDP/QMS. GMP Platform You can learn at any time and as much as you need CM Plus offers eLearning courses which you can use at any time and any place such as open seminars held at a venue or on-site seminars held at our client's office. We offer tailor-made educational programs for companies which are too busy to develop and carry out their own programs. CM Plus's...

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Technical Information Services

Home/ Services/ Technical Information Services ServicesTechnical Information Services The environment surrounding facilities and equipment requiring advanced environmental control, such as those in the life sciences and semiconductor sectors, is evolving to become more international, diverse in scope, and demanding in terms of information processing.Our company, which thrives on challenges in engineering and life sciences manufacturing quality, offers comprehensive information services to support our clients’ international operations. These services address topics related to GMP (Good Manufacturing Practice), QMS (Quality Management Systems), and the latest technological advancements, including digitalization.In addition, we provide product services that include engineering information tools and education and training related to quality. GMP Platform Aggregating knowledge to solve our clients’ challenges GMP Platform is a free information site established based on CM Plus Corporation’s founding principle of addressing various quality-related issues in life sciences facilities while staying close to our customers. We offer a variety of technical articles and translated and explained guidelines. In addition to GMP (Good Manufacturing Practice), we also share information related to clinical and non-clinical studies, as well as quality and safety for medical devices, cosmetics, and even food products. CM Plus aims not only to disseminate the expertise of our experienced in-house consultants and engineers through this site but also to gather and integrate knowledge from top consultants worldwide to help solve any challenges our clients may face. GMP Platform Internet Virtual Exhibition for Life Science Life Science Company Information Platform Life Science Company Information Platform is a specialized portal site where top suppliers, who constitute the robust supply chain in the life sciences industry, showcase and share extensive information on their latest technologies, products, and services. Those seeking the latest information on technologies, products, and services related to life sciences can access a wealth of information from various perspectives provided by the...

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Consultants

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