Medical Device Registration in Japan

Utilize our intimate industry knowledge and expertise to obtain Japan PMDA registration approval for your medical device.

Medical Device Registration in Japan

For a free consultation with an expert in Japan’s PMDA and MHLW regulations, contact us now.

Registration of medical devices in Japan is complicated, costly, and will generally take between 1-3 years depending on the device classification. In some cases, Japanese regulators require clinical trials in Japan to be conducted, and the costs of these trials can be very high. Product registration in Japan needs to be pursued carefully and only after determining that there is a strong market demand for your product.

Medical device registration in Japan may require that you have PMDA consultation sessions. The first PMDA consultation session is normally for 30 minutes and is free. Typically at this free consultation, the PMDA will not answer your questions but recommend you attend a more formal PMDA consultation. Formal paid PMDA consultations can cover a variety of sessions including a pre-development consultation, a clinical trial consultation, etc. These formal PMDA consultations are not cheap, and the applicant needs to submit some appropriate regulatory information in Japanese, prior to each meeting.

In addition, before medical device registration in Japan, it is always best to determine likely reimbursement in Japan. Japanese will only use medical products/services if they are reimbursed. Reimbursement codes in Japan include A1, A2, A3, B1, B2, B3, C1, and C2. For the A reimbursement categories, all medical procedures including diagnosis and treatment are paid by a fixed fee. For the B categories, the costs of disposable one-time use medical devices are allocated by function category. C reimbursement categories will have a new function and/or have new therapies. Japan will also utilize foreign reference pricing (FRP). For FRP, Japan will take the unweighted average price of the US, England, France, Germany, and Australia. If the price in any one or two countries exceeds the specified Japanese formulas, the average foreign price may be determined by only 4 or 3 of these 5 countries.

As the use of software for medical purposes has become increasingly ubiquitous, in April 2021, Japanese health authorities established several new regulatory units dedicated to the review and approval of software as medical devices (SaMD). The regulatory unit at the MHLW is responsible for evaluating the safety and efficacy of SaMD products, while the office at the PMDA is in charge of reviewing applications by foreign medical device manufacturers. Japan is also considering the use of the “Sakigake” fast-track approval system on software-driven devices in order to accelerate the approval of innovative SaMD.

Pacific Bridge Medical can help you streamline the medical device registration process in Japan so that you can obtain approval for your product in the most cost-effective and timely manner. We can also act as your Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH) in Japan. Our regulatory affairs consultants in Japan will ensure that you have maximum flexibility in your marketing and increased control over your brand.

PBM works with a number of Western CDx companies to register their CDx products in Japan. Please click here to learn more.

If you would like to learn more about the registration requirements and regulatory pathway for medical device products in Japan, please click on the following questions.

Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?

In Japan, are medical devices required to be registered before they can be sold?

Yes, medical devices are required to be registered before they can be sold.

What are the different regulatory classifications for medical devices?

What are the different application categories for medical device registration?

Application Category Overview
New medical devices
(clinical trial data required)		 Medical devices that are clearly different from those with approval or certification in Japan in terms of structure, principle, method of use, efficacy, and/or performance. GCP clinical trial data must be provided to prove clinical safety and efficacy.
Improved medical devices
(clinical trial data required)		 This category is for medical devices that 1) do not have an applicable approval standard or do not meet the requirements of the approval standard; 2) cannot be proven to be “me-too” devices (refer to the “me-too” medical device section below); 3) are not regarded as new medical devices (refer to the section above); and 4) cannot be proven safe and effective with non-clinical data.
Improved medical devices
(clinical trial data NOT required)		 This category is for medical devices that 1) do not have an applicable approval standard or do not meet the requirements of the approval standard; 2) cannot be proven to be “me-too” devices (refer to the “me-too” medical device section below); 3) are not regarded as new medical devices (refer to the section above); and 4) can be proven safe and effective with non-clinical data.
“Me-too” medical devices
(clinical trial data NOT required)		 This category is for medical devices regarded as the “me-too” type that 1) do not have an applicable approval standard or do not meet the requirements of the approval standard; 2) are not regarded as new medical devices or improved medical devices (refer to the sections above); and 3) can be proven safe and effective with non-clinical data.
“Me-too” medical devices
(clinical trial data NOT required and compliant with approval standards)		 This category is for medical devices regarded as the “me-too” type that 1) have an applicable approval standard and meet the requirements of the approval standard; and, 2) can be proven compliant to the approval standard.

What does the registration pathway look like for each regulatory classification?