Medical Device Registration and Approval in Japan

ANSWERED ON THIS PAGE:

• What is the classification scheme for medical devices?
• What are the registration procedures in Japan?
• How do regulatory requirements differ for domestic vs. foreign manufacturers?

Understanding Japan's medical device registration requirements

Japan is considered one of the more challenging markets for foreign medical device manufacturers due to its complex registration process and language barriers. But once you understand the device registration process, you will see that it is actually not complicated and the rewards are worth the effort. 

Japan's medical device regulation and approval process

Medical device companies interested in offering their products in Japan must comply with Japan's Pharmaceuticals and Medical Devices Act (PMD Act). Complying with the PMD Act can be challenging for foreign manufacturers, as very few regulatory documents are published in English.

As part of the approval process, medical device manufacturers must:

• Comply with MHLW Ordinance No. 169 related to quality management systems
• Appoint an in-country representative (MAH/D-MAH)
• Register design and manufacturing facilities, among other requirements

Registration procedures for medical devices sold in Japan

The registration pathway for your device is determined by its classification and associated Japan Medical Device Nomenclature (JMDN).

To market medical devices in Japan, your Marketing Authorization Holder (MAH) must register your device through one of the following procedures. Emergo can assist you with any medical device approval in Japan, regardless of classification or JMDN code.

Pre-market notification (Todokede)
To register General Medical Devices (Class I), you must file a pre-market submission to the PMDA. No review/assessment by the PMDA will be conducted.

Pre-market certification (Ninsho)
Class II (and a limited number of Class III) devices which have an associated certification standard (JIS), are subject to pre-market certification. Many, but not all, Japan Industrial Standards are based on existing ISO/IEC standards. Your MAH will file your application with a Registered Certification Body (RCB). The process is similar to the European CE Marking process where reviews are outsourced to a third party similar to a Notified Body.

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 your MAH will file a pre-market approval application with the PMDA and ultimately obtain approval from the MHLW.

Emergo by UL can help navigate PMDA regulations for medical devices

With an experienced team in Tokyo, Emergo can assist your company with the medical device registration process in Japan. Here's how we can help:

• Device classification: we will assess the classification for your medical device.
• Documentation preparation: Emergo can prepare all necessary documentation for pre-market notification, certification, and approval.
• QMS consulting and implementation: our quality consultants are experts in Ministerial Ordinance #169 and ISO 13485. We can help you comply with QMS regulations in Japan.
• Clinical consulting: Emergo can assist with the PMDA pre-submission consultation process if you need to confirm the necessity of clinical data, additional clinical trials, or the validity of your protocol for clinical trials and/or other testing.

Emergo's team in Tokyo has worked on hundreds of PMDA medical device and IVD registrations, so we fully understand the process and how to get your device approved as efficiently as possible. Please contact us for more information on obtaining medical device approval in Japan.

Frequently Asked Questions about PMDA Registration in Japan

How are devices classified in Japan?
Medical devices in Japan are classified using a coded predicate system combined with a rule-based risk assessment based on GHTF classification rules. Japan Medical Device Nomenclature (JMDN) codes identify the device classification and registration pathway. Devices are segmented into General Class I, Specified Controlled Class II, Controlled Class II, Specified Highly Controlled Class III, Highly Controlled Class III, or Highly Controlled Class IV.

How long does it take to register devices in Japan?
Timelines for medical device registration in Japan vary considerably depending on your device classification. Download our informative PDF chart (English) for details on the process and timelines.

Will our clinical studies and testing conducted outside Japan be accepted?
The PMDA often accepts the results of clinical trials conducted outside Japan if the investigation conforms to Japan's Good Clinical Practices. We can provide you with the support necessary to take a pre-submission consultation meeting with the PMDA to determine acceptability of the foreign clinical data. If the PMDA requires additional clinical investigations, Emergo can assist you with contracts, GCP documentation, clinical investigation document review, and more.

Can we "own" our Japanese device registration?
The MHLW permits manufacturers with no location in Japan to register their own Class II, III, and IV devices through the Foreign Special Approval System (FSAS). This registration route allows you to own your device registrations in your own name and take on some of the responsibilities of the Marketing Authorization Holder (MAH). However, because you have no Japanese office, you still need to appoint a licensed Designated Marketing Authorization Holder (D-MAH) in Japan that will coordinate shipment releases to your distributor and handle complaints and vigilance.

Manufacturing establishment registration for domestic manufacturers vs. foreign manufacturers
The PMD Act defined a new registration system for manufacturers. The registration system requires domestic manufacturers to register their manufacturing establishments with their local prefectural government and obtain Manufacturer Registration (MR). Foreign manufacturers, on the other hand, must register their manufacturing establishments with the PMDA and obtain a Foreign Manufacturer Registration (FMR) certificate. The MR and FMR is a requirement of the application of medical device registration and needs to be obtained prior to the filing.