Language barriers and a complex registration process make Japan one of the most time consuming markets for medical device manufacturers to enter. Yet, the rewards are worth the effort. Japan’s lucrative medical device market is the third largest in the world, behind the US and Europe and still ahead of China.
Navigating the Japanese regulatory process
Medical device companies interested in selling their products in Japan must comply with Japan's Pharmaceutical and Medical Device Law (PMDL). For foreign manufacturers, complying with the PMDL can be challenging. Few English language documents have been issued by the Ministry of Health, Labour and Welfare (MHLW) and its division, the Pharmaceuticals and Medical Devices Agency (PMDA).
Japan “Toroku” Registration
Under the PMDL, a registration system known as “Toroku” requires domestic manufacturers to register their manufacturing facilities having manufacturing process of design, key manufacturing process, sterilization and warehouse of final product in Japan with the authorities at their local prefectures. Foreign manufacturers must register their manufacturing facilities with the PMDA.
Todokede, Ninsho and Shonin for medical devices in Japan
To market medical devices in Japan, the MAH must register the device through the following procedures. Emergo can assist you with any medical device approval in Japan, regardless of classification.
Pre-market Submission (Todokede) - CLASS I MEDICAL DEVICES
To register and market General Medical Devices (Class I devices), the MAH must file a Pre-Market Submission to PMDA. There is no review/assessment by the PMDA for Class I devices.
Pre-market Certification (Ninsho) - CLASS II MEDICAL DEVICES
Only Class II devices which are specified as Specified Controlled Devices are subject to Pre-market Certification. Class II devices other than Specified Controlled Devices are subject to Pre-market Approval.
The process is similar to European CE Marking using a Notified Body. Each Specified Controlled Medical Device must apply internationally harmonized standards as is the case with CE Marking
Pre-market Approval (Shonin) - CLASS II, III & IV MEDICAL DEVICES
To register and market a “Highly Controlled Medical Device” the MAH needs to file a Pre-market Approval Application with the PMDA and obtain their approval. Class II devices that are not Specified Controlled Devices are also subject to Pre-Market Approval.
Let Emergo assist you with PMDA medical device registration
With an experienced team in Tokyo, Emergo is prepared to assist your company with all aspects of the medical device registration process in Japan. Here’s how we can help:
- We will identify the correct classification and JMDN code for your medical device.
- Our Designated Marketing Authorization Holder (DMAH) services allow us to communicate with Japanese authorities on your behalf.
- Emergo can prepare all necessary documentation for pre-market submission, certification and approvals and coordinate the submission to the PMDA or the RCB.
- Emergo can assist to take PMDA Pre-Consultation before medical device registration process when you need to confirm with PMDA, for example, confirming necessity of clinical data, necessity of additional clinical trial, validity of protocol for clinical trial and/or other testings