In-vitro Diagnostic (IVD) Regulations and Registration in Japan

ANSWERED ON THIS PAGE:

• What is the classification scheme for IVDs in Japan?
• How do regulatory requirements differ for Japanese vs. foreign IVD manufacturers?
• What are the IVD registration procedures in Japan?

A complicated regulatory process and language barriers make Japan one of the most challenging markets for manufacturers of In-Vitro Diagnostic (IVD) devices. But for companies that try, Japan’s lucrative medical device market holds tremendous potential.

IVD classification in Japan

Unlike in major markets outside Japan, in Japan, IVD refers to In-Vitro Diagnostic agents, not In-Vitro diagnostic devices. For example, although devices for self-monitoring of blood glucose are often classified into In-Vitro diagnostic Device in the market outside Japan, the glucose meter is classified into medical devices, and the test strip is classified into In-Vitro Diagnostic agents separately in Japan. Therefore, the first step in the registration process is to determine if your product is a medical device or an IVD.

Your IVD’s risk level determines your registration route. Pre-market Notification (PMN, or Todoke) is for Class I IVD. Pre-market certification (PMC, or Ninsho) is for Class II IVD. Pre-market approval (PMA, or Shonin) is required for some Class II and Class III.

How to classify medical devices in Japan with JDMN nomenclature

Japanese Medical Device Nomenclature (JMDN) is governed by Japanese law and announced by the MHLW Official Journal. Once the applicable JMDN is determined, the IVD registration route, classification/definition, and applied certification/approval standards are automatically determined.

Because this information is in Japanese only, you need the help of a native speaker who is very familiar with the nuances of JMDN to find the correct code. Our team in Tokyo can assist you in determining the applicable JMDN code for your IVD.

Japan registration requirements for IVDs

IVD 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 IVD sold in Japan

Based on the results of classification and JMDN code confirmation, the next step is to identify the correct IVD registration route. This will determine the proper registration and testing procedures for your IVD. There are three types of IVD registration procedures:

• Pre-market approval (Shonin). To register and market Class III (and some Class I/II) IVDs, you file a Pre-market Approval Application with the PMDA and ultimately obtain approval from the MHLW. Novel IVD technology without any published standards or predicate devices must also go through the PMA process.
• Pre-market certification (Ninsho). To register and market most Class II IVDs, the D-MAH/MAH needs to file a Pre-Market Certification application with a Registered Certification Body (RCB), e.g., BSI, TUV, SGS, etc., and obtain their certification. Several European Notified Bodies are also Japanese RCBs.
• Pre-market notification (Todokede). To register and market a Class I IVD, your MAH only needs to file a Pre-Market notification to the PMDA with no technical assessment by an authority.

Emergo can help you determine the appropriate registration pathway for your IVD.

Emergo can assist you with IVD registration in Japan

With an experienced team in Tokyo, Emergo is prepared to assist your company with multiple aspects of the IVD registration process in Japan. Here's how we can help:

• IVD classification: we will identify the applicable classification and JMDN code for your IVD.
• Documentation preparation: Emergo can prepare all necessary documentation for pre-market submission, certification, and approvals. We can also assist with Foreign Manufacturing Establishment Registration.
• QMS consulting and implementation: our quality consultants are experts in MHLW Ordinance #169 and ISO 13485:2016. We can help you comply with QMS regulations in Japan and pass your PMDA/RCB conformity assessment.
• Clinical consulting: Emergo can assist with the PMDA pre-submission consultation process if you need to confirm the necessity of clinical data or additional clinical trials, or the validity of protocol for clinical trials and/or other testing.

IVD registration in Japan is best left to experienced regulatory experts who fully understand Japan's IVD compliance process and can work with the PMDA on your behalf. Let Emergo help get your products registered in Japan as we have done for hundreds of companies worldwide.

Please contact us for more information about IVD approval in Japan

Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.

Japan's IVD regulations and registration FAQs

How long does it take to register IVDs in Japan?
Timelines for IVD registration in Japan vary depending on the classification. General Class I – IVDs can be registered in less than one month but higher classes can take anywhere from 6-12 months. Ask us for details.

Will our clinical studies and testing conducted outside Japan be accepted?
The PMDA usually accepts the results of clinical trials conducted outside Japan if the investigation conforms to Japan’s regulatory requirements. However, new IVDs may require clinical data. We can assist you in conducting a pre-submission consultation meeting with the PMDA to determine acceptability of your foreign clinical studies. If the PMDA requires additional clinical investigations conducted in Japan, Emergo can assist you with clinical investigation document review and more.