Research on National Laws, Regulations, and Standards
- Key points:
- We identify only information that is relevant to your research and development or patent applications, thereby improving the efficiency of the information collection process.
- We help to facilitate systematic research by reporting on the international conformity of regulations and standards and any differences with practices in Japan.
- We monitor business trends to ensure we can respond quickly to requests for support with your research and development endeavors and patent applications.
- We conduct detailed research that focuses on specific issues so that we can provide timely and well-informed answers to your questions.
■ Solution Case Studies
- Initial research
- In the initial phase of overseas development, we provide you with a broad overview of the relevant legal system and market.
- Case Study 1: Medical equipment (South Korea)
We conducted extensive research on bulletins and detailed enforcement regulations (which explain in detail how the national law is enforced) relating to medical equipment licensing systems. We also obtained application guidelines for specific types of equipment.
- Case Study 2: IT equipment (Russia, Ukraine, Argentina, and the Republic of South Africa)
We conducted research on the conformity of different countries’ systems with IEC 60950, as well as on legal regulations, authentication procedures, and authentication marks.
- Case Study 3: Medical equipment (France and Germany)
Since France’s regulations on sterilization and disinfection are stricter than those of other EU countries, we searched for websites that provided information on regulations in France and identified available documents. We conducted a similar survey on regulations in Germany.
- Periodic research
- We perform periodic monitoring of the latest trends in safety regulations and the relevant industry, including reports on defective products.
- Case Study 1: Medical equipment (France and Germany)
We monitored specified websites every month and submitted reports on our findings. In these reports, we described how and where we had obtained the specified documents and summarized their content.We managed the specified documents by storing them in Excel databases. If the client wanted a more detailed understanding of a specified document, we provided them with a translation.
- Detailed research
- Once we have provide you with a broad overview, we collect detailed information on specific matters of interest.
- Case Study 1: Customs procedures (mainly developing countries)
We identified solutions to problems related to customs procedures. Once we had done that, we proposed a framework for problem solving based on interviews with staff in the relevant agencies on the specific procedures required to correct document defects in accordance with strict customs rules.
- Case Study 2: Medical equipment (China)
Local interpretations of detailed operational rules and regulations regarding the re-registration of medical equipment were unclear, necessitating the establishment of guidelines to enable appropriate measures to be taken. Taking advantage of SunFlare’s local contacts, we identified notifications providing detailed procedural rules and interviewed local experts on their interpretations of procedural rules.