Medical device registration in Japan
Ministry of Health, Labor, and Welfare (MHLW) – The MHLW is Japan’s primary regulatory body for creating and implementing safety standards for medical devices and drugs. Within the MHLW, the Pharmaceutical and Food Safety Bureau is in charge of pharmaceutical and medical device regulatory policy.
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.
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.
Rely on us for :
Rely on us for :
Classifying devices
Selecting the authorization procedure
Preparing and reviewing authorization documents
Finding an MAH
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
