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Comprehensive Guide to Medical Device Registration in Japan and Common Pitfalls to Avoid

Time：2026-07-06 11:28:01

Japan, as a mature and high-end global medical device market with strong consumption capacity and a sound healthcare system, is a key destination for many Chinese medical device enterprises expanding overseas. However, Japan’s regulatory system under the Pharmaceuticals and Medical Devices Act features strict supervision, detailed classification rules, and fragmented administrative governance. Many enterprises face prolonged registration cycles and repeated supplementary corrections due to misunderstandings of the rules, missing market entry windows. This article comprehensively breaks down the core logic of medical device registration in Japan to help you quickly clarify access requirements.

一、Definition of Medical Devices in Japan

As defined in Paragraph 4, Article 2 of the Pharmaceuticals and Medical Devices Act, medical devices refer to instruments, equipment and other articles used for the diagnosis, treatment or prevention of human/animal diseases, or those affecting the structure and functions of the human/animal body.

Japan implements a division of responsibilities by authority, with different competent authorities corresponding to different determination matters:

Determination of medical device attributes: Judged by local prefectural governments, based on comprehensive assessment of the product’s intended use, mode of application, impact on human body functions, promotional statements, etc.
Device class and classification: Conventional products can be self-assessed by benchmarking against competing products; innovative/improved products need to be confirmed through consultation with the Pharmaceuticals and Medical Devices Agency (PMDA).
Compliance with certification standards: Judged by third-party certification bodies. If the certification body cannot make a determination, the matter may be submitted to PMDA for confirmation.

Important reminder: A local government’s ruling that a product is a medical device does not necessarily mean it can be registered via the medical device pathway (typical examples include beauty devices such as hair removal devices). Japan’s administrative system is characterized by fragmented jurisdiction. It is essential to clarify the responsibilities of each link before declaration to avoid detours.

二、Four Device Categories Corresponding to Distinct Registration Pathways

Medical devices in Japan are divided into 4 categories by risk level to the human body, from low to high. The classification directly determines the application method, processing cycle and project difficulty.

Class 1 General Medical Devices

Risk level: Extremely low riskTypical products: Standard scalpels, forceps, stethoscopes, medical eyeglassesRegistration method: PMDA filingReference duration: Approximately 1 month

Class 2 Controlled Medical Devices

Risk level: Relatively low riskTypical products: Blood pressure monitors, magnetic therapy devices, general massagersRegistration method: Certification by a third-party certification bodyReference duration: 6 months to 1 year

Class 3 Highly Controlled Medical Devices

Risk level: Relatively high riskTypical products: Contact lenses, dialysis machines, dental implantsRegistration method: PMDA approval application (multiple in-person consultations required)Reference duration: Over 1 year (without clinical trials)

Class 4 Highly Controlled Medical Devices

Risk level: Extremely high risk; malfunctions directly endanger lifeTypical products: Cardiac pacemakers, coronary stentsRegistration method: PMDA approval application (clinical trials are generally required)Reference duration: Over 2 years

Note: For Class 2 and Class 3 devices with corresponding official certification standards, the third-party certification pathway applies. For those without corresponding certification standards, the PMDA approval pathway is required. The applicability of standards must be confirmed prior to application.

三、Full Registration Process

For overseas medical devices entering the Japanese market, the standard process consists of 5 core stages, which are closely linked and cannot be reversed.

(1) Confirm Classification and Application Route

Based on the product’s intended use, structure and risk level, confirm its specific classification under the Pharmaceuticals and Medical Devices Act, and lock in the filing/certification/approval application path. This step is the strategic foundation of the entire registration project, directly determining subsequent document preparation and cycle planning.

(2) Appoint a Japan-based Registration Holder

The regulation mandates that overseas manufacturers cannot apply in their own name directly. They must entrust a local Japanese Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (D-MAH) as the license holder, who shall bear legal responsibility for the entire product lifecycle.

(3) Foreign Manufacturer Registration (FMR)

Overseas manufacturing plants must complete Foreign Manufacturer Registration with PMDA to confirm the legality and compliance of the manufacturing premises. This is a prerequisite for submitting product registration applications.

(4) Submit Product Registration Application

Submit a full set of documents according to the pathway corresponding to the product classification:

Class 1: Submit filing documents to PMDA
Class 2: Submit certification application to a third-party certification body accredited by the Ministry of Health, Labour and Welfare (MHLW)
Class 3 / Class 4: Submit approval application to PMDA, accompanied by technical documentation, risk management documents, performance test reports, QMS system documents, etc.

(5) Obtain Approval and Launch Compliantly

After passing official review, the corresponding filing number, certification certificate or approval number will be obtained. After the product is launched, it must continuously comply with compliance requirements such as Quality Management System (QMS) and Good Vigilance Practice (GVP) for legal distribution and sales.

四、Required Legal Qualifications

Japan’s medical device industry chain has a clear division of labor. In the import chain, four types of entities — manufacturers, warehouses, importers and distributors — each require corresponding legal qualifications.

(1) Overseas Manufacturers

Required qualification: Foreign Manufacturer Registration (FMR)
Processing requirements: Basic factory information is sufficient for registration; ISO 13485 certificate and complete system documents shall be supplemented at the product certification stage
Accepting authority: PMDA

(2) Local Japanese Warehousing Entities

Required qualification: Medical device manufacturing business registration
Processing requirements: Have a compliant product storage site; assign 1 management personnel with a science and engineering background as the responsible person
Accepting authority: Local government at the company’s location

(3) Importers (Manufacturing and Marketing Business Operators)

There are three levels of licenses corresponding to the risk levels of products:

First-class manufacturing and marketing business license: Covers Class 1, 2, 3 and 4 devices
Second-class manufacturing and marketing business license: Covers Class 1 and 2 devices
Third-class manufacturing and marketing business license: Covers Class 1 devices

Requirements for the first-class license: A General Supervisor (with science and engineering background), a Quality Management Officer (with more than 3 years of relevant experience) and a Safety Management Officer (with more than 3 years of relevant experience) must be appointed. Requirements vary slightly among prefectures. Conditions for the second and third-class licenses are correspondingly more lenient.

Accepting authority: Local government at the company’s location

(4) Distributors

Required qualifications: License for sales of highly controlled medical devices (for Class 3, 4 devices and specific maintenance Class 1 and 2 devices); Filing for sales of controlled medical devices (for non-specific maintenance Class 2 products)
Processing requirements: Assign 1 management personnel with a science and engineering background as the responsible person
Accepting authority: Local government at the company’s location

五、Common Pitfalls in Registration

Problems most frequently occur in the following links of medical device registration in Japan. Enterprises are advised to conduct advance screening and avoidance.

Incorrect classification and application pathway: Failure to accurately determine the Japan Medical Device Nomenclature (JMDN) classification leads to deviation in the application pathway; or unreasonable selection of benchmark products for equivalence comparison fails to support the substantial equivalence conclusion, directly resulting in project restart.
Substandard quality of Summary Technical Documentation (STED): Inconsistent descriptions of product use, specifications and performance indicators throughout the document; professional deviations in the translation of original Chinese documents (PMDA has extremely strict requirements on this); lack of key technical explanations such as algorithm principles and measurement principles.
Insufficient performance evaluation data: Test methods only comply with Chinese/CE standards and do not meet local Japanese technical requirements; test sample size lacks statistical basis; evaluation model does not match actual clinical use scenarios.
Formalistic risk management: Severe templating of risk analysis without combining product reality; risk control measures do not correspond one-to-one with product design; insufficient demonstration and explanation of residual risks.
Deficiencies in sterilization and biocompatibility: Sterilization verification does not meet the requirements of corresponding ISO standards; failure to provide data on the impact of repeated sterilization on product performance; biocompatibility evaluation is not carried out in full accordance with the ISO 10993 system.
Failure in QMS system audit: The scope of the ISO 13485 certificate does not match the applied product; unclear description of production process flow; lack of key system documents such as verification records, equipment calibration records and batch production records.

六、Conclusion

The Japanese medical device market has high thresholds and detailed rules, but also offers considerable market stability and return space after compliant entry. From classification determination, entity establishment to document preparation and official review, every step needs to accurately comply with local regulatory requirements. For further information, welcome to consult Wiselink!

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