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
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.
Establishment of QMS (Quality Management System)
In order to carry out the series of processes for the design, development, manufacturing, shipment, and sales of medical devices, a Quality Management System (QMS) is required, and first, the QMS must be established. In Japan, this is stipulated by the Ministry of Health, Labour and Welfare Ordinance No. 169 (QMS Ordinance). This Ordinance No. 169 largely aligns with ISO 13485 (2016 edition).
Notification, Certification Application, and Approval Application for Medical Devices
Once the design and development and manufacturing paln is prepard for product realization, notification, certification application, or approval application for the medical device is required. The choice among these depends on the risk level associated with the medical device.
For instance, a syringe without needle is categorized as Class I and requires notification, whereas one with a needle is Class II and requires a certification application. Additionally, devices such as catheters that are inserted into blood vessels require an approval application.
QMS Conformity Assessment
In the case of a certification application or an approval application, a QMS conformity assessment will be conducted after the application is submitted. This assessment determines whether the manufacturing management and quality management practices are indeed being implemented in compliance with the QMS Ordinance and ISO 13485 (2016 edition). For certification, this assessment is carried out by a Registered Certification Body, and for approved products, it is conducted by PMDA (Pharmaceuticals and Medical Devices Agency).
Marketing License
In the case of certification and approval applications, manufacturing and marketing are only possible once the application has passed and the QMS conformity assessment has been successfully completed.
New Market Entry Support Services by CM Plus
As shown in the examples above, various tasks arise based on regulatory requirements during the steps of a new market entry. CM Plus supports the execution of these tasks. We provide services that cater to your needs, ranging from full project support to partial assistance, such as validation only. The specific support contents are as follows:
Establishment of QMS
We assist in the establishment of a Quality Management System (QMS) that is as compact as possible, tailored to the scale of your operations. This includes support for the preparation of necessary documentation and the practical implementation of the system.
Support for Design Control
We assist in the design of newly developed medical devices by helping with the clarification of requirements, converting them into inputs, progressing with the actual design and development work, creating outputs, verifying outputs, validating outputs, and performing risk management tasks at key points.
Support for QMS Conformity Assessment Preparation
We provide assistance with preparatory work and services such as mock inspections in anticipation of inspections by certification bodies and PMDA.
Validation Support
When setting up the manufacturing process at the production site, we provide comprehensive support, from planning the validation to summarizing the reports.
Quality Management System: Continuous Improvement of QMS
Medical devices are tools for treatment and diagnosis, requiring continuous performance improvement, safety enhancement, and the ongoing improvement of the Quality Management System (QMS) itself. To support this continuous improvement, CM Plus offers the following services.
Additionally, many medical device manufacturers not only target the domestic market but also export to various countries worldwide. Regulatory requirements include not only Japan’s QMS regulations but also international standards such as ISO 13485 and the U.S. FDA’s Quality System Regulation (QSR). Exporting requires compliance with the regulations of the destination countries.
Continuous Improvement of the Quality Management System
Optimization of the Quality Management System (QMS)
We often see cases where the Quality Management System itself becomes bloated and difficult to manage, turning into a mountain of documents due to repeated corrections of issues pointed out in past ISO 13485 periodic audits. We support the reconstruction of a compact and easy-to-operate Quality Management System based on the PDCA cycle, tailored to the scale of the production facility and the number of items manufactured or sold.
Support for Building the Management Review System
The core of QMS is the management review in which top management is directly involved. CM Plus help optimize the content of management reviews and their formats to make it easier for top management to make decisions.
Support for Reviewing Corrective and Preventive Action Systems
The most frequently pointed out issues in external QMS audits are related to corrective and preventive actions. What are true corrective actions? What are effective methods for preventive actions? From these perspectives, we propose a review of the current system.
Design Control Support
When designing new medical devices, CM Plus support the following:
- Clarification of requirements
- Conversion to inputs
- Progression of actual design and development work
- Creation of outputs
- Verification of outputs
- Validation of outputs
- Risk management at critical points
Additionally, CM Plus provide comprehensive support for documentation, from protocol creation based on the PDCA cycle to report preparation.
CSV (Computerized System Validation) Support
Given the integration of software into medical devices, the sale of standalone software, and the use of specialized software in Quality Management Systems, CSV (Computerized System Validation) is now indispensable. We assist with the entire process, from CSV planning to report creation.
Support for Preparing for QMS Conformity Audits
We offer services to aid in the pre-preparation for QMS conformity audits by certification bodies and PMDA, including mock audits.
Validation Support
When establishing manufacturing processes in production facilities, we provide comprehensive support for validation, from planning to report compilation. Our services particularly include validation of related utilities for sterilization processes.
For validation of manufacturing facilities and building equipment, please see here.
CM Plus also offers pharmaceutical consulting and is capable of handling combination products (pharmaceuticals + medical devices).
Pharmaceutical GMP/GDP Consulting
GMP/GDP improvement, inspection support, GMP/GDP training, supplier management/procurement management support, and other M&A support services.
Introduction to e-Learning Services
“ISO 13485:2016 Medical Device QMS Practical Course”
We provide web-based training for ISO 13485.
Key Points of the Medical Device QMS Practical Course
This course responds to the 2016 revision of ISO 13485, covering the essentials required by ISO 13485 while explaining both the “changes in regulations revised in 2016” and “specific practical implementations.”
“Commentary on Quality Management System Process Diagram”
(From our eLearning, “Practically-Oriented Training Course on QMS for Medical Devices ISO 13485: 2016 Ver.” Course 2 Quality Management System)
