Understanding legislation and standards from around the world

The medical device market is growing not just in Japan, but in other parts of the world as well. Since this market growth is expected to continue, especially in the emerging countries of Asia and Africa, it is essential that growth-oriented businesses take the actions necessary to launch their medical device products in overseas markets.
Crucial to the global development of medical devices is an accurate understanding of country-specific legal and regulatory frameworks as well as the standards and regulations that apply to the relevant product.

SunFlare provides reliable support for the global marketing of medical devices by investigating the legal and regulatory frameworks as well as the standards and regulations that apply specifically to the client’s product (medical device, health care product, etc.).

Track record

  • We have conducted 190 investigations over the past 5 years.

Countries and regions covered to date

We have conducted investigations on the following countries and regions:
Vietnam, Indonesia, Thailand, Singapore, Mexico, the United States, Europe, India, Hong Kong, the Philippines, Canada, Australia, Brazil, Russia, Saudi Arabia, the United Arab Emirates, Turkey, Egypt, Uruguay, Panama, Peru, Argentina, Bahrain, and many more

Fields of investigation

  • Medical devices and in-vitro diagnostics
  • Other (nursing care devices, health care products, automotive and industrial equipment, etc.)

Fields of investigation

Case study #1: Investigations for the overseas launch of a medical device

For the overseas launch of a medical devices, we investigate requirements such as including the requirements criteria for for its classification as a medical device, the establishment of a quality management system (QMS), and application for the submission of the product approval application.

Examples of topics covered:

  • Regulatory Authority (RA)
  • Existence of third-party certification bodies
  • Main laws, regulations, and guidelines related to medical devices
  • Definitions of medical devices
  • Appropriateness of the relevant product's classification as a medical device
  • Overview of the classification system
  • Overview of licenses related to the production, sale, and importing of medical devices
  • Positioning of the manufacturer in the country of origin
  • Overview of regulations for product approval (registration)
  • Overview of medical device standards and national standards
  • Overview of regulations related to QMS
  • Post-marketing regulations
  • Overview of laws, regulations and guidelines related to commercial promotion and advertising
  • Overview of the medical insurance system

Case study #2: Investigations for the overseas launch of a quasi-medical devices

For the overseas launch of a quasi-medical device, which requires careful consideration to determine whether it should be classified as a medical device or a non-medical device, we investigate regulations and standards related to its classification as well as product safety.

Examples of topics covered:

  • Main laws, regulations, and guidelines related to medical devices
  • Definitions of medical devices
  • Identification of similar products that have met the regulatory requirements for medical devices
  • Judgment and discussion regarding the classification of the relevant product as a medical device
  • Regulations and standards related to the safety of the relevant product

Contact

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