SunFlare provides comprehensive, one-stop assistance in ensuring compliance with Japan’s Pharmaceutical and Medical Device (PMD) Act and overseas regulations in every stage of a medical device’s development, from its design through to its commercialization.
Consulting services for Japanese and overseas regulatory affairs
Medical device registration, ISO 13485, CE marking, market launch, standards compliance, etc.
Investigation of laws, regulations, standards and products
Investigation of laws and regulations, differences in regulatory and standard requirements, road maps, etc.
On-site seminars, courses, human resource development programs, etc.
Translation services for medical device documents
Applications and STED for marketing approval, QMS documents, marketing materials, country-specific regulations and standards, etc.