The cost and time to register a medical device in Japan will vary greatly depending on device classification and, more significantly, application of a predicacy system, the Japan Medical Device Nomenclature Code (JMDN code) system. Registrations are overseen by the Pharmaceuticals and Medical Devices Agency (PMDA) of the Ministry of Health, Labor and Welfare (MHLW) under the newly revised Pharmaceutical and Medical Device Law (PMDL), formerly the Pharmaceutical Affairs Law (J-PAL).
Low Risk Class I medical devices are subject to Pre-Market Submission (PMS) also known as ‘todokede.’ Applications are submitted to the PMDA and are considered accepted upon submission. It takes one week to issue a PMS number. There is no PMDA fee to process the application.
Most Medium Risk Class II and some High Risk Class III devices qualify for Pre-Market Certification (PMC), also known as ‘ninsho.’ Review of the medical device and quality systems conformity assessments are outsourced by the PMDA to Registered Certification Bodies (RCB). There are 14 RCBs, 7 of which are international companies that also offer Notified Body/Registrar services. The average time to process a PMC application is 3 months, with an average cost of US$30,000.
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.
PMDA Clinical Evaluation Consultation: If clinical evidence is required as part of the registration application, it is recommended to take this formal 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.
PMDA Clinical Study Consultations: Similarly, it is recommended to take a formal meeting with the PMDA 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.
Contact Asia Actual to see if we can help navigate the registration process for your medical device in Japan.