Addressing national differences in standards and regulations

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. Such actions include ascertaining and addressing differences in the standards and regulations of different countries around the world.

SunFlare investigates and analyzes differences in medical device requirements, including the various standards and regulations specific to the target market.

Case study #1: Investigation of differences in various technical and national standards

We investigate and analyze differences in standards related to the establishment of a quality management system (QMS) and product safety.

  • Gap analysis case study #1: Investigation of differences in the QMS requirements of different countries
    • Example: ISO 13485 vs. Korean Good Manufacturing Practice (KGMP)
  • Gap analysis case study #2: Analysis of differences in medical device standards of different countries
    • Example: Japan's Essential Requirements vs. the EU's Essential Requirements (Medical Device Directive[MDD])
  • Gap analysis case study #3: Analysis of differences in the technical standards of different countries
    • Example: China's YY standards vs. the US's ASTM standards

Case study #2: Investigation of differences between the standards and the clients current system in preparation for obtaining certification/approval for a medical device

We investigate the regulatory requirements specific to each target market and perform an investigation and analysis to determine how the clients current system differs from these requirements.

  • Gap analysis case study #1: For the overseas launch of a product that complies with Japanese regulations, we:
    • Identify the standards used for the design and development inputs and analyze any differences
    • Identify unique requirements in the QMS standards of different countries
    • Provide advice on how best to address the identified differences
  • Gap analysis case study #2: For a company with ISO 9001 certification that plans to obtain ISO 13485 certification, we:
    • Hold lectures on differences in the requirements of ISO 9001 and ISO 13485
    • Provide advice on how best to address the identified differences