Overview of entry into the medical device market

With medical needs expanding in emerging countries and populations continuing to age, the medical device market is expected to continue growing in both Japan and the rest of the world.

SunFlare provides consulting services tailored to each step involved in the launching of a medical device business, from establishing a framework for the medical device organization to commercializing the final product.

Workflow for entering the medical device market

Workflow for entering the medical device market

Track record

  • 77

    Projects related to supporting entry into
    the medical device market over the past 10 years

Consulting services provided by SunFlare

Lectures on entering the medical device market

We hold lectures on ascertaining the options and business categories available for entering the medical device market. As part of these lectures, we:

  • Explain the regulations for each category of health care products (medical devices, disability and care devices, and non-medical devices)
  • Explain the options available for entering the medical device market (manufacturers, original equipment manufacturers, and material suppliers)
  • Explain the roles and relationships of marketing authorization holders, manufacturing businesses, distributors, leasing businesses, and repair businesses
  • Identify the major benchmarks that need to be met in relation to regulatory affairs and present a roadmap
  • Provide an overview of relevant laws and regulations (e.g., the Pharmaceuticals and Medical Devices Act, the QMS Ordinance, and the GVP Ordinance)
  • Compare QMS standards (e.g. ISO 9001 and ISO 16949) with ISO 13485 and the QMS Ordinance
  • Provide advice (through on-site seminars) to new businesses entering the medical device industry

QMS and GVP systems

We assist in establishing, operating, and maintaining a quality management system (QMS) based on the QMS Ordinance and ISO 13485 as well as a Good Vigilance Practice (GVP) system based on the GVP Ordinance. As part of this assistance, we:

  • Provide consulting services that assist the client in understanding the requirements and making strategic decisions
  • Provide samples of QMS and GVP documents
  • Draft QMS and GVP documents
  • Review QMS and GVP documents prepared by the client
  • Provide consulting services that assist the client in operating a QMS and a GVP system
  • Assist in collecting post-marketing safety data and reporting to the authorities
  • Provide training programs for internal auditors and issue training completion certificates

Business licensing, registration and notification

We provide consulting services related to acquiring a license as a marketing authorization holder, a manufacturer, a distributor, a leasing business, or a repair business. As part of these services, we:

  • Verify the requirements for each business category and present a workflow for obtaining approval
  • Hold lectures on the qualifications required for the positions of General Controller and Responsible Engineering Manager
  • Draft applications and summary technical documentation (STED), provide information about the registration of business codes, etc.
  • Perform simulated examinations
  • Assist with and provide advice on consultations with the relevant local government and public health centers