Marketing medical devices in Japan

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

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:

  • Provide a roadmap to commercialization (for details, please see the Roadmaps for marketing medical devices)
  • Investigate previous and similar products and conduct a comparative analysis
  • Investigate the appropriateness of classifying the product as a medical device
  • Identify the applicable Japanese medical device nomenclature and classification and specify its purpose of use
  • Assess the novelty of the product, identify the correct submission category, and develop a course of action for regulatory submissions
  • Assist in consultations with the PMDA (as well as assist in preparing consultation documentation)
  • Assist in consultations with the relevant local governments and certification bodies

QMS establishment, operation and maintenance

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)

Product approval applications

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
III New medical device
II New medical device
Dental material
Diagnostic imaging system
Electrotherapy devics
Bio-information monitor
Home physiotherapy device
Stand-alone software medical device
I Wearable device Non-active

Post-marketing regulatory affairs

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

National Health Insurance (NHI) coverage

We provide comprehensive support related to coverage under Japan’s National Health Insurance (NHI) system. As part of this support, we:

  • Provide comprehensive advice on NHI coverage
  • Draft documents requesting that a product be covered under the NHI

Fixed-term contracts

We provide comprehensive support related to regulatory affairs for the period specified in our contract with the client. During this period, we:

  • Provide consulting services and advice to address any questions that may arise regarding regulatory affairs
  • Provide consulting services and advice tailored to specified themes
  • Respond to questions concerning any unclear or ambiguous matters via email.

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.