As any device manufacturer is aware, medical products throughout the globe are regulated according to each device’s targeted country of distribution. While conventional and/or equivalency products typically have a clearcut regulatory pathway, new or improved medical devices are often comprised of time-intensive and sometimes confusing regulatory approval routes. This is especially true for multinational manufacturers as they try to accurately understand the varying definitions of “equivalency” and the rules surrounding country-specific guidance, guidelines and notifications.
While Japan’s medical device landscape is no exception when it comes to complex regulatory rules, there are tools available to manufacturers wishing to gain device approval within the country, one of which is the Pharmaceuticals and Medical Device Agency (PMDA) consultation offering. In fact, the PMDA is now encouraging all global manufacturers wishing to distribute in Japan to secure a consultation prior to submitting device approval applications. The PMDA has also recently committed the organization to the reduction of “device lags” in hopes of lessening overall time to device approvals. (To see the PMDA’s updated consultation menu, click here.)
Medical Device & IVD Consultations
There are several types of medical device consultations available through the PMDA, all of which first require a complimentary “general meeting.” During this meeting, the PMDA provides recommendations for which type of consultation is most appropriate based on device specifications and the desired approval pathway. These meetings can be held face-to-face or via phone and typically last about 30 minutes. It is recommended that medical device organizations undergo a “pre-consultation meeting” following the general meeting; during this meeting, the applicant and PMDA regulator are able to discuss and clarify points made during the general meeting, in addition to examining any supporting materials that may be required. This pre-consultation meeting can be omitted, but is highly recommended given the relatively low investment (less than $250 U.S.).
The six (6) main types of consultations available for medical device manufacturers are:
- Consultation on pre-development of a medical device (before and during R&D phases)
- Consultation on the necessity of a clinical study
- Consultation on protocols within the following sub-categories: (i) Safety, (ii) Quality, (iii) Performance, (iv) Exploratory Clinical Trial, and (v) Clinical Trial
- Consultation on evaluation within the following sub-categories: (i) Safety, (ii) Quality, (iii) Performance, (iv) Exploratory Clinical Trial, and (v) Clinical Trial. (Data is reviewed during these meetings)
- Consultation on the sufficiency of materials submitted and submission category
- Consultation on pre-meeting for expansion of a clinical trial
Also available through the PMDA are nine (9) consultations for IVD manufacturers, including:
- General meeting
- Pre-consultation meeting
- Simple meeting
- Consultation on pre-development on IVDs
- Pre-development consultation on companion diagnostics (CoDx)
- Consultation on protocols within the following sub-categories: (i) Quality, (ii) Performance (other than Quality), (iii) Correlativity, (iv) Clinical Performance Tests, and (v) Clinical Performance Tests for CoDx (Data is reviewed during these types of meetings)
- Consultation on evaluation within the following sub-categories: (i) Quality, (ii) Performance (other than Quality), (iii) Correlativity, (iv) Clinical Performance Tests, and (v) Clinical Performance Tests for CoDx
- Consultation on submission procedure
- Additional consultation options
Following any of the above meetings, if an applicant has amended documents as a result of the recommendations made during the general meeting and wishes to receive additional advice regarding the acceptability of the amended materials, an additional consultation of the same category can be held (referred to as the “additional consultation on medical devices”).
If a device manufacturer already has an approved product on the market but is planning changes (which are required to be listed in the Ministry of Health, Labor and Welfare [MHLW] Notification No. 0731-5), a simple “consultation for pre-confirmation of notification” is required. (It is important to note that the PMDA allows multiple submissions using the same submission dossier and reports through their “simultaneous submission” consultation option.)
The goal of the PMDA’s now increasingly available consultation meetings are to allow manufacturers direct access to regulators. This not only allows device organizations to better understand potential regulatory hurdles, set expectations and obtain buy-in, but also helps manufacturers in identifying how to best proceed with product development and testing requirements.
Preparing for Successful PMDA Consultations
Well prepared consultation presentations with the right experts are key to building beneficial relationships with the PMDA and typically result in more streamlined and efficient submissions and approval processes. NAMSA’s team of Japanese regulatory experts are available to discuss with you how to best navigate this unique medical device development landscape, including how to adequately prepare for PMDA consultation efforts.