To market a medical device in Japan, you need to obtain approval and certification by submitting a registration application to the Pharmaceuticals and Medical Devices Agency (PMDA) and other certification bodies. The application must include written documents demonstrating the safety, efficacy and quality of the relevant device.
SunFlare provides consulting services tailored to each step in the marketing process for medical devices.
Marketing process for medical devices
Consulting services provided by SunFlare
Strategies for regulatory affairs
We provide pre-development regulatory consulting services related to the marketing of medical devices in Japan. As part of these services, we:
We assist with the establishment, operation and maintenance of a quality management system (QMS) based on Japan’s QMS Ordinance. As part of this assistance, we:
Hold detailed lectures on QMS requirements (QMS System Ordinance, QMS Ordinance and GVP Ordinance)
Analyze the client’s existing QMS to determine whether it complies with the requirements of Japan’s QMS Ordinance
Propose detailed solutions and provide consultations on any non-compliance issues
Provide samples and draft QMS documents, including quality manuals, provisions, procedure manuals, and record forms
Review QMS documents prepared by the client
Provide QMS training and internal auditor training (as well as provide textbooks and issue training completion certificates)
We assist in drafting premarket notifications, applications for marketing certification, as well as applications, summary technical documentation (STED), and package inserts (draft) for marketing approval. We also assist in consultations with the PMDA and/or other certification bodies. As part of this support, we:
Formulate an application strategy and provide assistance suited to the attributes of the device
Hold lectures on registration applications, notifications and STED
Formulate a strategy for submitting the application and hold technical meetings
Work with the client to examine the method to be used for ensuring compliance with the basic requirement standards and other applicable regulations
Assist in preparing premarket notifications, applications for marketing certification, and applications and STED for marketing approval
Hold lectures on preparing notifications, applications, and STED
Identify related notifications and missing source documents
Draft notifications, applications, and STED based on the source documents
Hold technical meetings
Assist in drafting the package insert -Draft the package insert based on the source documents and review its content
Translate the instructions for use (IFU), documents related to risk management, etc. (for foreign products imported into Japan) ※For details on the preparation of technical documents during design development, see Compliance with standards during design development.
Assist in consultations with the PMDA and/or other certification bodies
Provide a list of certification bodies and assist in making an appropriate choice
Provide support in communicating with the PMDA and/or other certification bodies (assist in the preparation of documentation for consultation as well as help and provide advice on responding to inquiries)
Types of medical devices
We provide assistance related to the submission of product approval applications for device categories ranging from Class I to Class IV, including new medical devices. The following are a few examples of the product types we have handled in each category.
Class
Product type
Active/Non-active
IV
Central vascular catheter Cerebrovascular stent
Non-active Non-active
III
New medical device Catheter
Non-active Non-active
II
New medical device Dental material Diagnostic imaging system Electrotherapy devics Bio-information monitor Home physiotherapy device Stand-alone software medical device
Active Non-active Active Active Active Active Active
We provide assistance related to post-marketing regulatory affairs. As part of this assistance, we:
Assist in drafting partial and minor change applications and responding to any inquiries from the PMDA concerning the applications
Collect post-marketing safety management data, such as information concerning malfunctions of the client’s product or similar products, and assist in reporting to the relevant authorities
Monitor technical levels and trends in standards related to the client’s product, similar products and rival products
SunFlare supports its clients in their efforts to comply with country-specific regulatory requirements. We offer a wide range of services, including providing information and conducting customized investigations regarding the laws and regulations of specific countries or regions, assisting and providing expertise in the preparation of approval application documents for submission to local regulatory authorities and certification bodies, creating sales promotion materials and assisting in post-marketing safety management.
