MI Tech K.K.

MEDICAL DEVICE REGISTRATION

MI Tech K.K., was one of the first medical device registration contract-service agencies to be established in Japan. We support medical device companies in their entry into the Japanese market.

Our services include:

1. Providing consultations, advising, and preparing documents for approval by the Japanese regulatory authorities.
2. Developing strategies to successfully negotiate the Japanese regulatory review process.
3. Liaising with the Pharmaceutical and Medical Device Agency (PMDA), the Ministry of Health, Labor and Welfare(MHLW) and third parties.

MEDICAL DEVICE SERVICE

• Summarizing technical dossiers.
• Liaising with PMDA, MHLW and third parties.
• Developing strategies for regulatory pathways and reimbursement pricing.
• Designing protocols for pre-clinical trials, clinical studies and tests for design-input.
• Recruiting and organizing teams of surgeons for clinical trials.
• Providing professional education for new products.
• Preparing documentation for FDA, Proposition 65, and UL, in the USA; and CE marking, REACH, and RoHS in Europe.

COMPANY INFORMATION