Special challenges apply to device manufacturers that wish to launch new technology in the Japanese market with regard to (1) regulatory access, (2) reimbursement enrollment and (3) sales promotion. It is important to coordinate and pursue all three disciplines more or less in parallel.
New Medical Technology Registration
New Class II, Class III and Class IV devices are subject to Pre-Market Approval (PMA), also known as ‘shonin’ by the PMDA. Application processing time and PMDA/MHLW fees will vary from 6 months and US$20,000 to 36 months and US$120,000, depending on classification, JMDN code application, and requirements for clinical evidence.
Harmonization by doing…In some cases we can argue successfully for acceptance of foreign clinical data. In other cases, we must conduct a full or partial clinical trial in Japan. For new devices that require a clinical trial for a US PMA, we can realize significant cost savings by combining US and Japan studies through the so-called Harmonization By Doing program.
If clinical evidence is required as part of the registration application, it is recommended to take this formal PMDA Clinical Evaluation Consultation meeting with the PMDA to determine if your data is sufficient for a successful application. The PMDA fee for the 2- hour meeting is approximately US$10,000.
Similarly, it is recommended to take a formal PMDA Clinical Study Consultation meeting to confirm if your clinical study is designed such that the data will be acceptable for a medical device registration application. The PMDA fee for the 2-hour meeting is approximately US$10,000.
Special fast track system
New Medical Technology Reimbursement
New medical device will likely qualify for C1 (new technology) or C2 (new function) categories are eligible for new or premium pricing…based on cost account methodology ..government application fees of US$30,000. Ideally start just before product registration…24 month process….involve KOL and academia engagement and support development
Insured Medical Materials Organization (IMMO)
confirmatoin by Central Social Insurance Medical Council (Chuikyo)
Entry into National Health Insurance (NHI) reimbursement list
New Medical Technology Sales Promotion
Asia Actual employs a stellar team of bi-lingual Americans residing in Japan 15 over years of hands on knowledge and experience working in the sales and marketing functions with Japanese distribution companies as well as foreign multinationals.
Contact Asia Actual to see if we can help navigate the registration process for your medical device in Japan.