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Japan PMDA Clinical Data Evaluation and GCP Compliance with MHLW Ordinance 36

ANSWERED ON THIS PAGE:

  • How do we know if our clinical data fulfills Japanese regulations?
  • What is the PMDA pre-consultation program?
  • What’s the next step if clinical trials are required for our device?

Most foreign companies entering the Japanese market have conducted device trials outside of Japan. However, clinical trials conducted in Japan may be necessary if your device is "new to market" or "high risk" with few predicate devices in the Japanese market. In this case, The Ministry of Health, Labour and Welfare (MHLW) enforces Ordinance No. 36, "GCP Regulation," concerning the Standards for Executing Clinical Tests on Medical Devices.

Determining your clinical data requirements in Japan

When the clinical efficacy and safety of a medical device cannot be evaluated based only on the results of non-clinical investigations, such as performance tests, animal tests, existing literature, etc., a clinical study must be conducted and technical documents on the results of the clinical investigation must be submitted.

A number of factors determine if technical documents for clinical investigation records are necessary, including:

  • the characteristics of the particular medical device,
  • equivalency with an existing medical device,
  • and non-clinical investigation results.

Our team in Tokyo has deep expertise in clinical data requirements and can assist you in negotiations with the Pharmaceuticals and Medical Devices Agency (PMDA) to determine whether additional clinical studies will be necessary to support your registration.

Clinical trial consultations with the PMDA

Emergo can represent your company during a Clinical Trial Necessity Consultation. As the name implies, the PMDA will evaluate your device’s non-clinical or clinical data, and the trial protocol if your clinical study was conducted outside Japan.  

If a study is required in Japan, Emergo can represent you during a Clinical Trial Consultation during which the PMDA reviews and confirms the design of the clinical trial you wish to conduct in Japan. In both cases, we can also meet with the PMDA prior to these very important meetings to informally discuss issues, concerns, and questions you may have.

Emergo can help with PMDA clinical data evaluations

Emergo's experienced consultants in Tokyo can help with every stage of the clinical data evaluation, from the pre-meeting to post-consultation, if needed. We will ensure you get the most benefit from your meetings with the PMDA, which are all conducted in Japanese. Even if the PMDA requires additional clinical trials for your product, we can assist with all aspects of the process, including:

  • Prepare documentation to PMDA to request a consultation.
  • Attend consultations and handle all correspondence with PMDA.
  • Analyze your clinical data, consult with medical experts if needed, and prepare your clinical evaluation report according to PMDA guidelines.
  • Prepare your pre-market approval or pre-market certification application.
  • Research and prepare cost estimates for conducting clinical trials in Japan, if needed.

Common questions

Does the PMDA charge a fee for consultation?
No, the PMDA does not charge a fee.

Do we need to translate our protocol and clinical trial results into Japanese prior to the clinical trial consultations with PMDA?
All documents for the PMDA Clinical Necessity Consultation must be in Japanese. Emergo Japan can assist with English-to-Japanese document translation.

Our high-risk, novel device is being sold in numerous other markets with good post-market results. Do we still need clinical consultation with the PMDA?
The PMDA takes an objective approach to evaluating clinical data. Even if your device has a good record in other markets, the need for additional clinical studies will be evaluated based on your compliance with Japanese clinical requirements. Manufacturers of devices that require clinical data are advised to take advantage of the PMDA consultation program to determine their requirements in advance and avoid costly delays in the registration process.