The complex registration process of medical devices in Japan makes the market one of challenging ones for foreign manufacturers. Upon understanding the process, the complication eases, and the results are compliant and worth the efforts. Medical device companies interested in offering their products in Japan, must abide by Japan's Pharmaceuticals and Medical Devices Act (PMD Act). Medical devices in Japan are classified based on their risk; which are divided into 4 classes such as:
- CLASS I- General (low-risk)
- CLASS II- Specified Controlled (low/medium risk)
- CLASS II- Controlled (medium-risk)
- CLASS III- Highly Controlled (medium/high risk)
- CLASS IV- Highly Controlled (high-risk)
Based on the class of the device, Regulatory pathway is defined. Following are the Regulatory pathways for registering medical devices in Japan.
Pre-market submission (Todokede)
General Medical Devices (Class I) can file a pre-market submission to the PMDA. This is a notification, and no review/assessment by the PMDA will be conducted. Class I devices only require registration via the Todokede process.
Pre-market certification (Ninsho)
Class II (and a limited number of Class III) devices which have an associated certification standard (Japan Industrial Standard - JIS), are subject to pre-market certification. Many, but not all, JIS are based on existing ISO/IEC standards. Your MAH will file your application with a Registered Certification Body (RCB). The process is like the European CE Marking process where reviews are outsourced to a third party like a Notified Body. Class IV, and the majority of Class III devices, require the Shonin process. Most Class II devices, and a few Class III devices, follow the Ninsho pathway.
Pre-market approval (Shonin)
Class II and III devices without a specific certification standard, are subject to the pre-market approval process. This also applies to all Class IV devices. In this case a MAH will have to file a pre-market approval application with the PMDA to obtain approval from the MHLW. Class II products that do not hold, or comply, with the Ninsho Certification Standard can be approved via the Shonin pathway.
For Todokede and Shonin Regulatory pathways, the permission is granted by the PMDA, whereas for Ninsho it is done by the third-party agency i.e. Registered Certified Body.
With the growing demand for medical devices in Japan, manufacturers must be aware of region-specific terms and their definitions in detail. To know more about Todokede, Ninsho, Shonin Regulatory pathways for Medical Devices, reach us at firstname.lastname@example.org.