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Japan is the second biggest market for Medical devices and is expected to reach US $74.4 billion by 2025. Key factors driving growth in the Japanese medical device market are:
Though the market looks promising, the major barrier in tapping the market is the stringent Pharmaceuticals and Medical Devices Agency (PMDA) regulations that Medical Device companies must abide by.
Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) working under the Ministry of Health Labour and Welfare (MHLW)
Regulation: Pharmaceuticals and Medical Devices Act (PMD Act)
Regulatory Pathway: Pre-Market Submission or Pre-Market Certification or Pre-Market Approval
Authorized Representative: MAH/D-MAH
QMS Requirement: Ordinance No. 169, MDSAP Certification
Assessment of Technical Data: Third party for Class II devices and PMDA for Class III and IV devices
Validity of License: Unlimited
Labeling Requirements: PMD Act
Submission Format: Paper
Language: Japanese
Japan has a clear-cut device classification system. The devices are classified into 4 classes based on the risk associated with the device. The registration procedure, document requirements, Technical assessment varies with the class of the device.
Device Class |
Risk |
Class I |
Low Risk |
Class II |
Low/Medium Risk |
Class III |
Medium/High Risk |
Class IV |
High Risk |
Foreign manufacturers should appoint a Market Authorization Holder (MAH) as a pre-requisite to market devices in Japan. However, the PMDA allows to appoint a Designated Market Authorization Holder (D-MAH). In the former case, MAH owns and controls the registration and certificate/approval of the product. In the latter case, Foreign manufacturer owns and controls the registration and certificate/approval of product and D-MAH acts as a representative in Japan. It is ideal to appoint a D-MAH rather than MAH as the process to change a D-MAH is easier than changing the MAH.
All the foreign manufacturing companies which intend to export their devices into Japan must register themselves with the Ministry of Health, Labor and Welfare (MHLW). This registration procedure is called as Foreign Manufacturer Registration (FMR), which formerly was known as “Foreign Manufacturer Accreditation (FMA)” or “Accreditation of Foreign Manufacturers (AFM)”.
The registration pathway in Japan depends on various factors such as class of device, assigned JMDN, availability of predicate device and availability of associated Japanese Industrial Standard (JIS). Various registration pathways in Japan are detailed below -
Freyr supports the foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:
Despite having an established medical device Regulatory framework, navigating through Japan’s device classification system and respective registration procedures may require proven expertise.
Freyr, as a strategic Regulatory partner, provides end-to-end Medical Device Regulatory services that span across quality control, classification, clinical safety, and market access. We assist clients in all the procedural challenges right from Regulatory intelligence to dossier preparation and submission to product registration.
Controls |
Device Class |
Risk / Classification Criteria |
Approval Routes |
Agency |
Timelines |
General |
Class I |
Low Risk |
Pre-Market Submission (Todokede) |
NA |
1 Month |
Specified Controlled |
Class II |
Low/Medium Risk |
Pre-Market Certification (PMC / Ninsho) |
Notified Body |
3-5 months |
Controlled |
Class II |
Medium Risk |
Pre-Market Approvals (PMA / Shonin) |
PMDA |
7-9 Months |
Highly Controlled |
Class III |
Medium / High Risk |
Pre-Market Approvals (PMA / Shonin) |
PMDA |
9 - 12 Months |
Highly Controlled |
Class IV |
High Risk |
Pre-Market Approvals (PMA / Shonin) |
PMDA |
13-16 Months |
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