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Japan is a lucrative market for medical devices. It is a $2B industry and steadily growing. However, registering a device in Japan can be complicated and expensive. To register a medical device in japan, you must first appoint a Market Authorization Holder (MAH). The MAH is responsible for identifying the class of the medical device. Japanese health authority, Pharmaceutical and Medical Device Agency (PMDA), classifies medical device in four classes:

  1. Class I Devices: These are generic devices that pose minimum risk to the patients. Examples include plasters, casts, and microscopes.
  2. Class II Devices: These are non-invasive devices that pose very little risk to the patients. Examples include CT scanner, X-Ray devices and so on.
  3. Class III Devices: These are controlled devices that can pose serious risks to the patients in case they malfunction. Some examples are artificial organs and bypass circuits.
  4. Class IV Devices: These devices tend to be highly invasive and can potentially be fatal to the patient if they malfunction. These include controlling devices like pacemakers and implants.

The class of the device then clarifies which registration procedure MAH should follow. Japan has three different pathways for device registration, viz. Shonin (Pre-market Approval), Ninsho (Pre-Market Certification) and Todokede (Pre-market submission). Ninsho and Shonin pathways are for various class II and II devices, while Todokede can be used for Class I devices.

Process for Todokede

Todokede or pre-market submission procedures for general medical devices is straightforward once the documentation is in place. It:

  • allows for self-certification
  • requires no review/assessment by the PMDA
  • takes less than one month for processing
  • can be processed with ease
  • is referred to be approved, once submitted
  • is not time-bound to expire

Todokede Process Flowchart

 

Step-by-step Explanation

1) Identify the class of the device using JMDN number

Market Authorization Holder should first determine the class of the device using the Japanese Medical Device Nomenclature (JMDN) codes. As per the PMDA, the devices can be classified into five classes depending on the risk.

2) Appoint an MAH in Japan

For Class I devices, i.e. for the Todokede registration process, an MAH should be appointed in Japan.

3) If a foreign manufacturer, submits an FMR to PMDA

If a manufacturer is of foreign origin, it is required to submit a Foreign Manufacturer Registration (FMR) to the PMDA

4) QMS Certification

Though most of the Class I devices do not require MHLW Ordinance #169 documentation, some of them require Quality Management System (QMS), even if they are new devices. A QMS conformity (Kijun Tekigoshou) certificate is issued by PMDA upon successful completion of quality assessment.

5) Local Language Restrictions

While submitting Todokede to the PMDA, MAH based in Japan must ensure that all documents are in Japanese

6) Submission

Submit Todokede complying with all requirements and obtain approval

7) Reimbursement

Irrespective of the class, all device should file a reimbursement application with economic affairs division of MHLW to notify the health authority that the product is being marketed.

Japan’s medical device market is lucrative, but it comes with language barriers, strict regulations, and complex processes. Freyr’s in-house experts can help you navigate through the various processes and requirements. Talk to us at sales@freyrsolutions.com.