In the most recent edition of Qualtech’s Webinar series, our Japan registration experts informed interested participants from all corners of the world about the medical device registration process in Japan. Japan — representing one of the most highly developed medical device markets in the world — yet still strongly relies on imported medical devices, which make up around 50% of the market. Thus, it is important for foreign medical device manufacturers to understand the necessary regulatory procedures in order to be able to gain approval from the Japanese authorities:
1. Regulatory Authorities and Other Key Players:
There are three main regulatory authorities in Japan, including Japan’s Ministry of Health, Labor, and Welfare (MHLW), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the 13 Registered Certification Bodies (RCBs). The Japanese Ministry of Health is thereby mostly responsible for issuing and revising regulations. PMDA on the other hand, represents an independent institution, which is in charge of ensuring the safety, efficacy, and quality of pharmaceutical and medical devices. They review pre-market medical devices while focusing on medium to high-risk products. For low to medium risk products, they are generally reviewed by the Registered Certification Bodies (RCBs).
When entering the Japanese Medical Device market, it is important to note that the Product Registration License is not the only license that is required. Other important licenses and key players are the following:
- 1.1. Foreign Manufacturers:
The Foreign Manufacturer needs to obtain Foreign Manufacturer Accreditation (FMA) in Japan for manufacturing sites that conduct Design, Sterilization, and/or Main Assembly. Afterward, they must also get QMS-inspected by PMDA or an RCB. In addition, the foreign manufacturer shall assign and contract a local DMAH/MAH as well as its selected distributor(s) for Japan. Qualtech’s webinar speakers also pointed out that Foreign Manufacturers are able to assign multiple distributors in Japan, if so desired.
- 1.2. Designated Marketing Authorization Holder (DMAH) or Marketing Authorization Holder (MAH):
The DMAH or MAH are the entities that serve as the authorized representatives for foreign manufacturers. In order to be eligible to do so, they must be authorized by the local government by having obtained Marketing Authorization. The DMAH/MAH conducts the final market release and ensure quality and safety standards. The DMAH will also make a quality agreement with the foreign manufacturer’s distributor(s) for the final warehouse (in case the final warehouse is owned by the distributor). In response to one of the webinar participant’s questions, Qualtech’s speakers highlighted that the DMAH and the Distributor can hypothetically be the same entity, as long as the company has all related DMAH and Distributor licenses.
Essential is furthermore, that as stated in the Japanese regulations, the DMAH/MAH has to be the entity that submits the product registration application to Japan’s PMDA or to the RCBs, respectively. However, it is important to note that the DMAH/MAH cannot sell medical devices to any end-users.
- 1.3. Distributor and Repairer:
In order to sell and/or repair, the entities have to obtain the Distributor’s License or Repairer’s License. Ultimately, the distributor represents the only entity that can directly sell medical devices to the end-users. However, distributors, unlike the DMAH/MAH, are not authorized to conduct market releases. The distributor is moreover required to report any AE to the designated DMAH/MAH.
As for the repairer, even in case the medical device is repaired abroad, the medical device must nonetheless ultimately be shipped by the Repairing License Holder.
1.4. Local Manufacturers:
Local manufacturers are important to foreign manufacturers, as the latter is obligated to assign local final storage in Japan to import products. Thus, they are required to assign either a local manufacturer or another entity with a local manufacturing license as the local final storage and for conducting incoming inspections.
2. Classification of Medical Devices in Japan:
During Qualtech’s webinar, two different main ways to classify medical devices in Japan have been introduced. Namely, the general risk classification, and the detailed classification.
2.1. General Classification:
As for the general classification, there are four risk classifications, with Class I being the lowest risk class. Class I products do not have to get reviewed by the Japanese authorities, but only require notification to PMDA (self-certifying). Most Class II products on the other hand, will be either certified by an RCB. Yet, certain Class II products nonetheless require review and approval by PMDA. In turn, most Class III products require review and approval by PMDA, while a small number of Class III products – such as reusable insulin pen injectors or anesthesia depth monitors - can be certified by an RCB. Class IV products; however, are exclusively reviewed and approved by PMDA.
2.2. Detailed Classification:
The detailed classification is based on the general classification. However, it takes three additional factors into consideration:
Factor 1 - Does PMDA provide product criteria for the product?
This refers to the JMDN codes given to Medical Devices in Japan, similar to the GMDN codes in the EU. JMDN codes thereby are generic names, which are used to identify medical devices. Most of the JMDN codes are given specific Approval Criteria (Standards) in order to obtain product registration licenses. However, some JMDN codes are not given criteria, in which case consultation with PMDA is necessary.
Factor 2 - Is the product a generic device, improved device, or a new medical device?
- Generic Devices represent devices that are substantially equivalent (such as structure, intended use, efficacy, performance) to an existing product that has been approved by the Japanese authorities.
- Improved Devices: Devices that do not have any novelty, but that are not substantially equivalent to existing products that have been approved by the Japanese authorities.
- New Devices: Devices whose structure, intended use, efficacy, and performance are clearly different from existing products that have been approved in Japan.
Factor 3 - Does your product require clinical data?
- Clinical Data does not have to be presented in case efficacy and safety are different from the predicate device, but equivalency can be proven by non-clinical data.
- However, clinical data needs to be presented, in case efficacy and safety are different from the predicate device and equivalency can be proven only by clinical data.
Thus, with those three factors in mind, there are a total of 5 different classification possibilities:
3. Consultations with Japan’s PMDA:
As based on the above 5 cases for Class II to Class IV products, only the Generic Devices, that have product criteria provided by PMDA and that do not need to present clinical data, are not obligated to undergo consultation with PMDA. In the other 4 cases, and if PMDA does not provide approval standards for your product, consultation with PMDA is mandatory.
PMDA consultation consists of General Consultation (30 minutes and at no cost), Preparation Consultation (summarizes agenda and necessary documents), Protocol Consultation (checking protocols of clinical and non-clinical tests, the documents must be submitted to PMDA 3 weeks before the appointment), and potentially additional consultations as assigned and determined by PMDA.
Noteworthy for foreign manufacturers is the option of applying for an information disclosure request to MHLW or PMDA prior to the consultations with PMDA. This request will enable manufacturers to view the dossier of already approved products along with other important documents. Thus, if granted, it will significantly assist foreign manufacturers in understanding what kind of approval standards have been used for the respective predicate devices.
4. Japan Registration Routes:
Overall there are three certificates that are needed for foreign manufacturers. The first one being the Foreign Manufacturer Accreditation (FMA), which has a validity of 5 years. Manufacturing sites that require accreditation are those that are involved in the Design, Assembly, Sterilization, and Final Storage. PMDA’s review time for Foreign Manufacturer Accreditation is around 4 months
Secondly, the Quality Management System Certificate (QMS) likewise has a validity of 5 years. However, PMDA’s reviewing time for QMS is 10 to 12 months. Manufacturing sites that are accredited must receive QMS inspection. Depending on certain conditions, this can be a paper-based inspection, or in some incidences, an on-site inspection may be required.
Lastly, the Product Approval Certificate needs to be attained via PMDA or the respective RCB. It is important to note that in Japan, the product approval certificate does not have an expiry date. In case the product is being reviewed by PMDA, the reviewing time is approximately 10 to 12 months. Yet, if an RCB is reviewing the product, the reviewing time can be slightly shorter. The final product approval certificate will only show information regarding the DMAH and the manufacturer, but no information related to the distributor.
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